Trial Outcomes & Findings for Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer (NCT NCT00455533)

Last Updated: 2016-02-24

Results Overview

The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

384 participants

Primary outcome timeframe

at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

Results posted on

2016-02-24

Participant Flow

A total of 384 participants were enrolled in this study; 71 did not receive any study medication.

Participant milestones

Participant milestones
Measure	Doxorubicin / Cyclophosphamide (AC) 60 mg/m\^2 doxorubicin and 600 mg/m\^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).	Ixabepilone ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel Paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Period One: Initial Chemotherapy STARTED	313	0	0
Period One: Initial Chemotherapy COMPLETED	295	0	0
Period One: Initial Chemotherapy NOT COMPLETED	18	0	0
Period Two: Randomized Period STARTED	0	145	144
Period Two: Randomized Period COMPLETED	0	139	138
Period Two: Randomized Period NOT COMPLETED	0	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxorubicin / Cyclophosphamide (AC) 60 mg/m\^2 doxorubicin and 600 mg/m\^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).	Ixabepilone ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel Paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Period One: Initial Chemotherapy Adverse Event Not Related to Study Drug	1	0	0
Period One: Initial Chemotherapy Disease Progression	5	0	0
Period One: Initial Chemotherapy Lost to Follow-up	2	0	0
Period One: Initial Chemotherapy Not Reported	1	0	0
Period One: Initial Chemotherapy Other--Need Reasons	2	0	0
Period One: Initial Chemotherapy Study Drug Toxicity	2	0	0
Period One: Initial Chemotherapy Subject Request to Discontinue Study	1	0	0
Period One: Initial Chemotherapy Subject No Longer Meets Study Criteria	2	0	0
Period One: Initial Chemotherapy Subject Withdrew Consent	2	0	0
Period Two: Randomized Period Death	0	0	3
Period Two: Randomized Period Disease Progression	0	1	1
Period Two: Randomized Period Lost to Follow-up	0	0	1
Period Two: Randomized Period Other - need reasons	0	1	0
Period Two: Randomized Period Study Drug Toxicity	0	2	0
Period Two: Randomized Period Subject Withdrew Consent	0	2	1

Baseline Characteristics

Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=295 Participants Total of all reporting groups	Ixabepilone (Randomized Population) n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel (Randomized Population) n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Age, Continuous	48.0 years n=5 Participants	48.0 years n=5 Participants	46.0 years n=7 Participants
Age, Customized <65 years	271 participants n=5 Participants	134 participants n=5 Participants	137 participants n=7 Participants
Age, Customized >=65 years	24 participants n=5 Participants	14 participants n=5 Participants	10 participants n=7 Participants
Age, Customized <50 years	167 participants n=5 Participants	85 participants n=5 Participants	82 participants n=7 Participants
Age, Customized >=50 years	128 participants n=5 Participants	63 participants n=5 Participants	65 participants n=7 Participants
Sex: Female, Male Female	295 Participants n=5 Participants	148 Participants n=5 Participants	147 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized White	150 participants n=5 Participants	74 participants n=5 Participants	76 participants n=7 Participants
Race/Ethnicity, Customized Black/African American	11 participants n=5 Participants	7 participants n=5 Participants	4 participants n=7 Participants
Race/Ethnicity, Customized Asian Indian	50 participants n=5 Participants	22 participants n=5 Participants	28 participants n=7 Participants
Race/Ethnicity, Customized Chinese	28 participants n=5 Participants	16 participants n=5 Participants	12 participants n=7 Participants
Race/Ethnicity, Customized Asian Other	31 participants n=5 Participants	17 participants n=5 Participants	14 participants n=7 Participants
Race/Ethnicity, Customized Unknown or Not Reported	25 participants n=5 Participants	12 participants n=5 Participants	13 participants n=7 Participants
Karnofsky Performance Status-Baseline 100 - Normal no complaints; no evidence of disease	210 participants n=5 Participants	107 participants n=5 Participants	103 participants n=7 Participants
Karnofsky Performance Status-Baseline 90 - Normal activity; minor signs of disease	67 participants n=5 Participants	28 participants n=5 Participants	39 participants n=7 Participants
Karnofsky Performance Status-Baseline 80 - Activity with effort; some signs of disease	18 participants n=5 Participants	13 participants n=5 Participants	5 participants n=7 Participants
Karnofsky Performance Status-Baseline 70 - Unable to carry on normal activity	0 participants n=5 Participants	0 participants n=5 Participants	0 participants n=7 Participants
Karnofsky Performance Status-Baseline <=60 Needs increasing assistance up to Death (0)	0 participants n=5 Participants	0 participants n=5 Participants	0 participants n=7 Participants
Menopausal Status Pre-Menopausal	146 Participants n=5 Participants	71 Participants n=5 Participants	75 Participants n=7 Participants
Menopausal Status Peri-Menopausal	12 Participants n=5 Participants	6 Participants n=5 Participants	6 Participants n=7 Participants
Menopausal Status Post-Menopausal	131 Participants n=5 Participants	67 Participants n=5 Participants	64 Participants n=7 Participants
Menopausal Status Not Reported	6 Participants n=5 Participants	4 Participants n=5 Participants	2 Participants n=7 Participants

PRIMARY outcome

Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants Achieving Pathologic Complete Response (pCR)	24.3 Percentage of Participants Interval 18.6 to 30.8	25.2 Percentage of Participants Interval 19.4 to 31.7

PRIMARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Population: For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size \[N\] not applicable).

Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 \[log2 normalized intensity units\], respectively (corresponding to prevalence rates of 43.3% and 44.3%).

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations Beta-III positive subgroup (cross-validation)	35.9 Percentage of Participants Interval 20.6 to 53.2	36.1 Percentage of Participants Interval 23.3 to 56.0
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations Beta-III negative subgroup (cross-validation)	17.4 Percentage of Participants Interval 10.3 to 27.1	22.4 Percentage of Participants Interval 13.1 to 32.0
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations Beta-III positive subgroup (n=43, 42)	34.9 Percentage of Participants Interval 22.9 to 48.5	35.7 Percentage of Participants Interval 23.5 to 49.5
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations Beta-III negative subgroup (n=71, 75)	18.3 Percentage of Participants Interval 11.2 to 27.5	22.7 Percentage of Participants Interval 15.0 to 32.0
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations TACC3 positive subgroup (cross-validation)	30.1 Percentage of Participants Interval 18.1 to 37.9	29.4 Percentage of Participants Interval 19.6 to 47.2
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations TACC3 negative subgroup (cross-validation)	19.8 Percentage of Participants Interval 10.8 to 30.7	27.0 Percentage of Participants Interval 13.2 to 41.4
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations CAPG positive subgroup (cross-validation)	30.7 Percentage of Participants Interval 18.9 to 47.4	35.3 Percentage of Participants Interval 24.0 to 49.9
Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations CAPG negative subgroup (cross-validation)	20.4 Percentage of Participants Interval 11.4 to 31.5	20.7 Percentage of Participants Interval 9.1 to 44.3

PRIMARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Population: For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.

For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)

Population: All randomized participants

Clinical response was defined as the number of participants who achieved modified World Health Organization's tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of \>= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants Achieving Clinical Objective Response	81.1 Percentage of Participants Interval 75.0 to 86.2	77.6 Percentage of Participants Interval 71.2 to 83.1

SECONDARY outcome

Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

Population: All randomized participants

Number of randomized participants requiring breast conservation surgery following study treatment.

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants Requiring Breast Conservation Surgery	41.9 Percentage of Participants Interval 35.1 to 49.0	32.7 Percentage of Participants Interval 26.3 to 39.6

SECONDARY outcome

Timeframe: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)

Population: All randomized participants

Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1	30.4 Percentage of Participants Interval 24.2 to 37.2	33.3 Percentage of Participants Interval 26.9 to 40.3

SECONDARY outcome

Timeframe: pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Relevance of biomarker in differentiation between ixabepilone \& paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR\~Biomarker:Treatment:estrogen receptor \[ER\]) \& reduced model (PCR\~Treatment:ER); 2) the likelihood ratio test between the full model (PCR\~Biomarker:Treatment) \& reduced model (PCR\~Biomarker+Treatment); 3) the contrast of the interaction between treatment \& biomarker expression within ER Negative subjects from the full model(PCR\~Biomarker:Treatment:ER). A:B represents A,B \& A\*B.

Outcome measures

Outcome measures
Measure	Ixabepilone n=295 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR ABCB1 (209993_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR ABCB1 /// ABCB4 (209994_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR BRCA1 (211851_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR BRCA1 (204531_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR ERCC1 (203719_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR ERCC1 (203720_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR GTSE1 (204315_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR GTSE1 (204317_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR GTSE1 (215942_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR GTSE1 (204318_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR GTSE1 (211040_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR KLK10 (209792_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR KLK10 (215808_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR KLK5 (222242_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR KLK6 (204733_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR RRM1 (201476_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR RRM1 (201477_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB (211714_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB (212320_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB (209026_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB1 (208601_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB2A (204141_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB2A /// TUBB2B (209372_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB2B (214023_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB2C (208977_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB2C (213726_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB4 (212664_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TUBB6 (209191_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TYMS (202589_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR TYMS (217684_at)	245 participants	—

SECONDARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Relevance of biomarker in differentiation between ixabepilone \& paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1\~Biomarker:Treatment: ER) \& reduced model (pCR/RCB1\~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) \& reduced model (pCR/RCB1\~Biomarker+Treatment); 3) contrast of the interaction between treatment \& biomarker expression within ER Negative subjects from the full model (pCR/RCB1\~Biomarker:Treatment:ER). A:B represents A,B \& A\*B.

Outcome measures

Outcome measures
Measure	Ixabepilone n=295 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 ABCB1 (209993_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 ABCB1 /// ABCB4 (209994_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 BRCA1 (211851_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 BRCA1 (204531_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 ERCC1 (203719_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 ERCC1 (203720_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 GTSE1 (204315_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 GTSE1 (204317_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 GTSE1 (215942_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 GTSE1 (204318_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 GTSE1 (211040_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 KLK10 (209792_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 KLK10 (215808_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 KLK5 (222242_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 KLK6 (204733_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 RRM1 (201476_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 RRM1 (201477_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB (211714_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB (212320_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB (209026_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB1 (208601_s_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB2A (204141_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB2A /// TUBB2B (209372_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB2B (214023_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB2C (208977_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB2C (213726_x_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB4 (212664_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TUBB6 (209191_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TYMS (202589_at)	245 participants	—
Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1 TYMS (217684_at)	245 participants	—

SECONDARY outcome

Timeframe: : pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Population: Randomized participants with non-missing pCR and biomarker expression

Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.

Outcome measures

Outcome measures
Measure	Ixabepilone n=111 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=117 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds Mem+Cyto Threshold/Negative Biomarker Status	0.143 percentage of participants Interval 0.069 to 0.252	0.288 percentage of participants Interval 0.193 to 0.4
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds Mem+Cyto Threshold/Positive Biomarker Status	0.323 percentage of participants Interval 0.225 to 0.433	0.259 percentage of participants Interval 0.167 to 0.37
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds Mem Threshold/Negative Biomarker Status	0.316 percentage of participants Interval 0.147 to 0.53	0.2 percentage of participants Interval 0.057 to 0.44

SECONDARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Population: Randomized participants with non-missing pCR/RCB1 and biomarker expression

Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .

Outcome measures

Outcome measures
Measure	Ixabepilone n=111 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=117 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds Mem+Cyto Threshold/Negative Biomarker Status	0.224 percentage of participants Interval 0.131 to 0.344	0.339 percentage of participants Interval 0.237 to 0.453
Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds Mem+Cyto Threshold/Positive Biomarker Status	0.371 percentage of participants Interval 0.268 to 0.483	0.362 percentage of participants Interval 0.257 to 0.478
Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds Mem Threshold/Negative Biomarker Status	0.316 percentage of participants Interval 0.147 to 0.53	0.267 percentage of participants Interval 0.097 to 0.511

SECONDARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.

Population: Randomized estrogen negative participants with non-missing pCR and biomarker expression

Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.

Outcome measures

Outcome measures
Measure	Ixabepilone n=64 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=70 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants Mem+Cyto Threshold/Negative Biomarker Status	0.192 percentage of participants Interval 0.079 to 0.363	0.483 percentage of participants Interval 0.32 to 0.648
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants Mem+Cyto Threshold/Positive Biomarker Status	0.447 percentage of participants Interval 0.309 to 0.593	0.341 percentage of participants Interval 0.22 to 0.481
Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants Mem Threshold/Negative Biomarker Status	0.417 percentage of participants Interval 0.181 to 0.685	0.3 percentage of participants Interval 0.087 to 0.607

SECONDARY outcome

Timeframe: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment

Population: Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.

Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive \[with 90% confidence interval by Bootstrap method\]): Beta 3 Tubulin IHC (45.866 \[5, 83.9\]); TACC3 mRNA (6.714 \[6.312, 7.192\]); CAPG mRNA (6.739 \[5.728, 7.298\]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.

Outcome measures

Outcome measures
Measure	Ixabepilone n=245 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) Beta 3 Tubulin IHC (n=231)	0.394 Percentage of Participants Interval 0.242 to 0.571	—
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) Beta 3 Tubulin IHC H-Score (n=231)	0.299 Percentage of Participants Interval 0.173 to 0.524	—
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) Beta 3 Tubulin mRNA (n=245)	0.392 Percentage of Participants Interval 0.167 to 0.772	—
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) TACC3 mRNA (n=245)	0.514 Percentage of Participants Interval 0.273 to 0.743	—
Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants) CAPG mRNA (n=245)	0.486 Percentage of Participants Interval 0.294 to 0.767	—

SECONDARY outcome

Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades

Outcome measures

Outcome measures
Measure	Ixabepilone n=148 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=147 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Death	0 Participants	2 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade (Gr) 1 (mild)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade 2 (moderate)	2 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade 3 (severe)	8 Participants	6 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade 4 (life-threatening)	6 Participants	3 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade 5 (death)	0 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any SAE, Grade Unknown	1 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants AE Leading to Discontinuation, Grade 1 (mild)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants AE Leading to Discontinuation, Grade 2 (moderate)	3 Participants	8 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants AE Leading to Discontinuation, Grade 3 (severe)	7 Participants	4 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants AE Leading to Discon, Grade 4 (life-threatening)	4 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any Drug-Related AE, Grade 1 (mild)	24 Participants	40 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any Drug-Related AE, Grade 2 (moderate)	45 Participants	54 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any Drug-Related AE, Grade 3 (severe)	46 Participants	24 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants Any Drug-Related AE, Grade 4 (life-threatening)	15 Participants	3 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Peripheral Sensory Neuropathy,Grade 1 (mild)	36 Participants	46 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE:Peripheral Sensory Neuropathy,Gr 2 (moderate)	21 Participants	21 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Peripheral Sensory Neuropathy, Gr 3 (severe)	6 Participants	5 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Peripheral Sensory Neuropathy, Grade 4	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Myalgia, Grade 1 (mild)	18 Participants	13 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Myalgia, Grade 2 (moderate)	19 Participants	5 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Myalgia, Grade 3 (severe)	4 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Myalgia, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Arthralgia, Grade 1 (mild)	15 Participants	12 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Arthralgia, Grade 2 (moderate)	18 Participants	2 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Arthralgia, Grade 3 (severe)	1 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Arthralgia, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Bone Pain, Grade 1 (mild)	10 Participants	5 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Bone Pain, Grade 2 (moderate)	11 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Bone Pain, Grade 3 (severe)	7 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Bone Pain, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Fatigue, Grade 1 (mild)	11 Participants	12 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Fatigue, Grade 2 (moderate)	11 Participants	10 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Fatigue, Grade 3 (severe)	5 Participants	2 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Fatigue, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Diarrhea, Grade 1 (mild)	19 Participants	11 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Diarrhea, Grade 2	4 Participants	5 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Diarrhea, Grade 3 (severe)	2 Participants	2 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Diarrhea, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Nausea, Grade 1 (mild)	18 Participants	16 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Nausea, Grade 2	6 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Nausea, Grade 3 (severe)	1 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Nausea, Grade 4 (life-threatening)	0 Participants	0 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Musculoskeletal Pain, Grade 1 (mild)	9 Participants	4 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Musculoskeletal Pain, Grade 2 (moderate)	5 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Musculoskeletal Pain, Grade 3 (severe)	1 Participants	1 Participants
Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants TNAE: Musculoskeletal Pain,Gr 4 (life-threatening)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy

Population: Ixabepilone- and Paclitaxel-treated participants

MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class GDASC AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Any Drug-Related AEs, Gr 3	55 Participants	32 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Any Drug-Related AEs, Gr 4	22 Participants	23 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Any Drug-Related AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Any Drug-Related AEs, Grade (Gr) 1	5 Participants	8 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Any Drug-Related AEs, Gr 2	56 Participants	69 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Gastrointestinal Disorder AEs, Gr 1	54 Participants	52 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Gastrointestinal Disorder AEs, Gr 2	42 Participants	44 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Gastrointestinal Disorder AEs, Gr 3	10 Participants	6 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Gastrointestinal Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Gastrointestinal Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class MCT Disorder AEs, Gr 1 (spell out)	36 Participants	28 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class MCT Disorder AEs, Gr 2	44 Participants	12 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class MCT Disorder AEs, Gr 3	12 Participants	3 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class MCT Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class MCT Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class GDASC AEs, Gr 1 (spell out)	51 Participants	47 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class GDASC AEs, Gr 2	28 Participants	23 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class GDASC AEs, Gr 3	9 Participants	6 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class GDASC AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Skin and Subcutaneous Tissue Disorder AEs, Gr 1	25 Participants	29 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Skin and Subcutaneous Tissue Disorder AEs, Gr 2	60 Participants	70 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Skin and Subcutaneous Tissue Disorder AEs, Gr 3	3 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Skin and Subcutaneous Tissue Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Skin and Subcutaneous Tissue Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Nervous System Disorder AEs, Gr 1	45 Participants	52 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Nervous System Disorder AEs, Gr 2	27 Participants	25 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Nervous System Disorder AEs, Gr 3	7 Participants	6 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Nervous System Disorder AEs, Gr 4	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Nervous System Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Blood & Lymphatic System Disorder AEs, Gr 1	4 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Blood & Lymphatic System Disorder AEs, Gr 2	13 Participants	15 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Blood & Lymphatic System Disorder AEs, Gr 3	20 Participants	15 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Blood & Lymphatic System Disorder AEs, Gr 4	15 Participants	21 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Blood & Lymphatic System Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Laboratory Investigation AEs, Gr 1	11 Participants	5 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Laboratory Investigation AEs, Gr 2	5 Participants	10 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Laboratory Investigation AEs, Gr 3	7 Participants	9 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Laboratory Investigation AEs, Gr 4	6 Participants	3 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Laboratory Investigation AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Metabolism & Nutrition Disorder AEs, Gr 1	13 Participants	8 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Metabolism & Nutrition Disorder AEs, Gr 2	9 Participants	8 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Metabolism & Nutrition Disorder AEs, Gr 3	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Metabolism & Nutrition Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Metabolism & Nutrition Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class RTM Disorder AEs, Gr 1 (spell out)	18 Participants	17 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class RTM Disorder AEs, Gr 2	1 Participants	6 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class RTM Disorder AEs, Gr 3	1 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class RTM Disorder AEs, Gr 4	1 Participants	3 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class RTM Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Infections & Infestations AEs, Gr 1	9 Participants	6 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Infections & Infestations AEs, Gr 2	8 Participants	7 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Infections & Infestations AEs, Gr 3	3 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Infections & Infestations AEs, Gr 4	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Infections & Infestations, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Psychiatric Disorder AEs, Gr 1	13 Participants	15 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Psychiatric Disorder AEs, Gr 2	3 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Psychiatric Disorder AEs, Gr 3	2 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Psychiatric Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Psychiatric Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Vascular Disorder AEs, Gr 1	12 Participants	17 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Vascular Disorder AEs, Gr 2	5 Participants	3 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Vascular Disorder AEs, Gr 3	1 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Vascular Disorder AEs, Gr 4	0 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Vascular Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Eye Disorder AEs, Gr 1	14 Participants	10 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Eye Disorder AEs, Gr 2	1 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Eye Disorder AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Eye Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Eye Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Immune System Disorder AEs, Gr 1	3 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Immune System Disorder AEs, Gr 2	2 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Immune System Disorder AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Immune System Disorder AEs, Gr 4	2 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Immune System Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Reproductive System and Breast Disorders, Gr 1	2 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Reproductive System and Breast Disorders, Gr 2	3 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Reproductive System and Breast Disorders, Gr 3	1 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Reproductive System and Breast Disorders, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Reproductive System and Breast Disorders, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Cardiac Disorder AEs, Gr 1	1 Participants	3 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Cardiac Disorder AEs, Gr 2	0 Participants	2 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Cardiac Disorder AEs, Gr 3	3 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Cardiac Disorder AEs, Gr 4	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Cardiac Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Ear and Labyrinth Disorder AEs, Gr 1	1 Participants	4 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Ear and Labyrinth Disorder AEs, Gr 2	3 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Ear and Labyrinth Disorder AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Ear and Labyrinth Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Ear and Labyrinth Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Renal and Urinary Disorder AEs, Gr 1	2 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Renal and Urinary Disorder AEs, Gr 2	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Renal and Urinary Disorder AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Renal and Urinary Disorder AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Renal and Urinary Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Injury, Poisoning&Procedural Complication AEs,Gr 1	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Injury, Poisoning&Procedural Complication AEs,Gr 2	1 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Injury, Poisoning&Procedural Complication AEs,Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Injury, Poisoning&Procedural Complication AEs,Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Injury, Poisoning&Procedural Complication AEs,Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Hepatobiliary Disorder AEs, Gr 1	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Hepatobiliary Disorder AEs, Gr 2	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Hepatobiliary Disorder AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Hepatobiliary Disorder AEs, Gr 4	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class Hepatobiliary Disorder AEs, Gr 5	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class NBMUCP AEs, Gr 1	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class NBMUCP AEs, Gr 2	0 Participants	1 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class NBMUCP AEs, Gr 3	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class NBMUCP AEs, Gr 4	0 Participants	0 Participants
Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class NBMUCP AEs, Gr 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase

Population: Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

Outcome measures

Outcome measures
Measure	Ixabepilone n=143 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=143 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 3	44 Participants	7 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 4	8 Participants	0 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 1-4	111 Participants	111 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase White Blood Cells (WBC), Grade 0	32 Participants	32 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 1	27 Participants	63 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 2	32 Participants	41 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase WBC, Grade 3-4	52 Participants	7 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Absolute Neutrophil Count (ANC), Grade 0	33 Participants	66 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 1	23 Participants	41 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 2	28 Participants	24 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 3	36 Participants	12 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 4	23 Participants	0 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 1-4	110 Participants	77 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ANC, Grade 3-4	59 Participants	12 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 0	109 Participants	134 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 1	33 Participants	6 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 2	0 Participants	2 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 3	1 Participants	1 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 4	0 Participants	0 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 1-4	34 Participants	9 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Platelets, Grade 3-4	1 Participants	1 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 0	13 Participants	8 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 1	77 Participants	91 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 2	51 Participants	37 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 3	2 Participants	6 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 4	0 Participants	1 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 1-4	130 Participants	135 Participants
On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Hemoglobin, Grade 3-4	2 Participants	7 Participants

SECONDARY outcome

Timeframe: prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase

Population: Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.

Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

Outcome measures

Outcome measures
Measure	Ixabepilone n=143 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=143 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 0 (n=142, 140)	72 Participants	52 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 1 (n=142, 140)	54 Participants	59 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 2 (n=142, 140)	13 Participants	22 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 3 (n=142, 140)	3 Participants	7 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 4 (n=142, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 1-4 (n=142, 140)	70 Participants	88 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase ALT, Grade 3-4 (n=142, 140)	3 Participants	7 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 0 (n=141, 140)	85 Participants	64 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 1 (n=141, 140)	51 Participants	64 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 2 (n=141, 140)	4 Participants	9 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 3 (n=141, 140)	1 Participants	3 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 4 (n=141, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 1-4 (n=141, 140)	56 Participants	76 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase AST, Grade 3-4 (n=141, 140)	1 Participants	3 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 0 (n=141, 140)	114 Participants	117 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 1 (n=141, 140)	27 Participants	23 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 2 (n=141, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 3 (n=141, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 4 (n=141, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 1-4 (n=141, 140)	27 Participants	23 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Alkaline Phosphatase, Grade 3-4 (n=141, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 0 (n=142, 140)	137 Participants	131 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 1 (n=142, 140)	4 Participants	8 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 2 (n=142, 140)	0 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 3 (n=142, 140)	1 Participants	0 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 4 (n=142, 140)	0 Participants	1 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 1-4 (n=142, 140)	5 Participants	9 Participants
On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Total Bilirubin, Grade 3-4 (n=142, 140)	1 Participants	1 Participants

SECONDARY outcome

Population: Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

Outcome measures

Outcome measures
Measure	Ixabepilone n=142 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=139 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 0	136 Participants	135 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 1	6 Participants	3 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 2	0 Participants	1 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 3	0 Participants	0 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 4	0 Participants	0 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 1-4	6 Participants	4 Participants
On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase Creatinine, Grade 3-4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles)

Population: ixabepilone- and paclitaxel-treated participants

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Number of Participants by Dose for AC Dose 1 (Week 3)	145 participants	144 participants
Number of Participants by Dose for AC Dose 2 (Week 6)	145 participants	144 participants
Number of Participants by Dose for AC Dose 3 (Week 9)	145 participants	142 participants
Number of Participants by Dose for AC Dose 4 (Week 12)	143 participants	141 participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

Population: ixabepilone- and paclitaxel-treated participants

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 1 (Week 3, ixabepilone; Week 1 paclitaxel)	145 participants	144 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 2 (Week 6, ixabepilone; Week 2 paclitaxel)	139 participants	142 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 3 (Week 9, ixabepilone; Week 3 paclitaxel)	130 participants	139 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 4 (Week 12, ixabepilone; Week 4 paclitaxel)	124 participants	139 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 5 (Week 5 paclitaxel)	0 participants	135 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 6 (Week 6 paclitaxel)	0 participants	135 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 7 (Week 7 paclitaxel)	0 participants	132 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 8 (Week 8 paclitaxel)	0 participants	131 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 9 (Week 9 paclitaxel)	0 participants	129 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 10 (Week 10 paclitaxel)	0 participants	128 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 11 (Week 11 paclitaxel)	0 participants	123 participants
Number of Participants by Dose for Ixabepilone/Paclitaxel Dose 12 (Week 12 paclitaxel)	0 participants	118 participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles)

Population: ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Reason for First Dose Reduction of AC Participants with at least 1 dose reduction of AC	5 participants	7 participants
Reason for First Dose Reduction of AC Adverse Event	1 participants	3 participants
Reason for First Dose Reduction of AC Hematologic Toxicity	3 participants	3 participants
Reason for First Dose Reduction of AC Non-Hematologic Toxicity	0 participants	1 participants
Reason for First Dose Reduction of AC Not Reported	1 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

Population: ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Participants with at least 1 dose reduction	18 participants	18 participants
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Adverse Event	10 participants	3 participants
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Hematologic Toxicity	2 participants	0 participants
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Non-Hematologic Toxicity	0 participants	4 participants
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Not Reported	1 participants	2 participants
Reason for First Dose Reduction of Ixabepilone/Paclitaxel Peripheral Neuropathy	5 participants	9 participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles)

Population: ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Number of Participants With Course Delay and Reason for Delay for AC Participants with at least 1 dose delay	41 participants	43 participants
Number of Participants With Course Delay and Reason for Delay for AC Administrative Reason	5 participants	6 participants
Number of Participants With Course Delay and Reason for Delay for AC Adverse Event	6 participants	10 participants
Number of Participants With Course Delay and Reason for Delay for AC Hematologic Toxicity	17 participants	10 participants
Number of Participants With Course Delay and Reason for Delay for AC Non-Hematologic Toxicity	3 participants	2 participants
Number of Participants With Course Delay and Reason for Delay for AC Not Reported	14 participants	16 participants
Number of Participants With Course Delay and Reason for Delay for AC Other	3 participants	1 participants
Number of Participants With Course Delay and Reason for Delay for AC Subject Request	2 participants	0 participants

SECONDARY outcome

Timeframe: 12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)

Population: ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel

Outcome measures

Outcome measures
Measure	Ixabepilone n=145 Participants ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 Participants paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Adverse Event	6 participants	15 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Participants with at least 1 dose delay	31 participants	51 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Administrative Reason	3 participants	5 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Hematologic Toxicity	10 participants	15 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Non-Hematologic Toxicity	0 participants	7 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Not Reported	13 participants	8 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Other	3 participants	8 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Peripheral Neuropathy	0 participants	1 participants
Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel Subject Request	0 participants	3 participants

Adverse Events

Ixabepilone

Serious events: 17 serious events

Other events: 128 other events

Deaths: 0 deaths

Paclitaxel

Serious events: 11 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ixabepilone n=145 participants at risk ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 participants at risk paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Investigations HAEMOGLOBIN DECREASED	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Cardiac disorders CARDIAC FAILURE	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Cardiac disorders ATRIAL FIBRILLATION	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Vascular disorders HYPOTENSION	0.69% 1/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Vascular disorders PERIPHERAL ISCHAEMIA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Immune system disorders ANAPHYLACTIC SHOCK	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Immune system disorders ANAPHYLACTIC REACTION	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Nervous system disorders HEADACHE	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Nervous system disorders SOMNOLENCE	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Nervous system disorders ENCEPHALOPATHY	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Nervous system disorders CRANIAL NEUROPATHY	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Nervous system disorders NEUROPATHY PERIPHERAL	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Nervous system disorders CEREBRAL VENOUS THROMBOSIS	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	1.4% 2/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Gastrointestinal disorders VOMITING	1.4% 2/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Gastrointestinal disorders DIARRHOEA	2.8% 4/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Gastrointestinal disorders ABDOMINAL PAIN	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Gastrointestinal disorders GALLSTONE ILEUS	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Infections and infestations SEPSIS	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Infections and infestations PNEUMONIA	0.69% 1/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders LEUKOPENIA	1.4% 2/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders NEUTROPENIA	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.69% 1/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders THROMBOTIC THROMBOCYTOPENIC PURPURA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders RASH	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders URTICARIA	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders EXFOLIATIVE RASH	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Injury, poisoning and procedural complications OVERDOSE	2.1% 3/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Injury, poisoning and procedural complications MEDICATION ERROR	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders MYALGIA	0.69% 1/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders COUGH	0.69% 1/145 Adverse events are reported for randomized population.	0.00% 0/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/145 Adverse events are reported for randomized population.	2.1% 3/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.69% 1/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders NON-CARDIOGENIC PULMONARY OEDEMA	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
General disorders FATIGUE	1.4% 2/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
General disorders PYREXIA	0.00% 0/145 Adverse events are reported for randomized population.	2.1% 3/144 Adverse events are reported for randomized population.
General disorders SUDDEN DEATH	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.
General disorders OEDEMA PERIPHERAL	0.00% 0/145 Adverse events are reported for randomized population.	0.69% 1/144 Adverse events are reported for randomized population.

Measure	Ixabepilone n=145 participants at risk ixabepilone 40 mg/m\^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)	Paclitaxel n=144 participants at risk paclitaxel 80 mg/m\^2 administered IV every week for 12 weeks
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.5% 8/145 Adverse events are reported for randomized population.	8.3% 12/144 Adverse events are reported for randomized population.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	2.8% 4/145 Adverse events are reported for randomized population.	6.2% 9/144 Adverse events are reported for randomized population.
Vascular disorders HOT FLUSH	5.5% 8/145 Adverse events are reported for randomized population.	8.3% 12/144 Adverse events are reported for randomized population.
Psychiatric disorders INSOMNIA	11.0% 16/145 Adverse events are reported for randomized population.	11.8% 17/144 Adverse events are reported for randomized population.
Nervous system disorders HEADACHE	4.1% 6/145 Adverse events are reported for randomized population.	6.2% 9/144 Adverse events are reported for randomized population.
Nervous system disorders DYSGEUSIA	1.4% 2/145 Adverse events are reported for randomized population.	5.6% 8/144 Adverse events are reported for randomized population.
Nervous system disorders PARAESTHESIA	6.9% 10/145 Adverse events are reported for randomized population.	2.8% 4/144 Adverse events are reported for randomized population.
Nervous system disorders NEUROPATHY PERIPHERAL	16.6% 24/145 Adverse events are reported for randomized population.	16.0% 23/144 Adverse events are reported for randomized population.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	18.6% 27/145 Adverse events are reported for randomized population.	30.6% 44/144 Adverse events are reported for randomized population.
Gastrointestinal disorders NAUSEA	18.6% 27/145 Adverse events are reported for randomized population.	12.5% 18/144 Adverse events are reported for randomized population.
Gastrointestinal disorders VOMITING	9.7% 14/145 Adverse events are reported for randomized population.	3.5% 5/144 Adverse events are reported for randomized population.
Gastrointestinal disorders DIARRHOEA	16.6% 24/145 Adverse events are reported for randomized population.	13.2% 19/144 Adverse events are reported for randomized population.
Gastrointestinal disorders STOMATITIS	4.1% 6/145 Adverse events are reported for randomized population.	7.6% 11/144 Adverse events are reported for randomized population.
Gastrointestinal disorders CONSTIPATION	6.2% 9/145 Adverse events are reported for randomized population.	6.2% 9/144 Adverse events are reported for randomized population.
Metabolism and nutrition disorders DECREASED APPETITE	8.3% 12/145 Adverse events are reported for randomized population.	6.2% 9/144 Adverse events are reported for randomized population.
Blood and lymphatic system disorders NEUTROPENIA	19.3% 28/145 Adverse events are reported for randomized population.	10.4% 15/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders RASH	9.0% 13/145 Adverse events are reported for randomized population.	11.1% 16/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders ALOPECIA	2.8% 4/145 Adverse events are reported for randomized population.	6.2% 9/144 Adverse events are reported for randomized population.
Skin and subcutaneous tissue disorders NAIL DISORDER	4.8% 7/145 Adverse events are reported for randomized population.	8.3% 12/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders MYALGIA	29.7% 43/145 Adverse events are reported for randomized population.	12.5% 18/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders BONE PAIN	20.7% 30/145 Adverse events are reported for randomized population.	4.2% 6/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders ARTHRALGIA	23.4% 34/145 Adverse events are reported for randomized population.	10.4% 15/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.5% 8/145 Adverse events are reported for randomized population.	4.9% 7/144 Adverse events are reported for randomized population.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	11.0% 16/145 Adverse events are reported for randomized population.	4.9% 7/144 Adverse events are reported for randomized population.
Respiratory, thoracic and mediastinal disorders COUGH	4.8% 7/145 Adverse events are reported for randomized population.	13.2% 19/144 Adverse events are reported for randomized population.
General disorders PAIN	6.9% 10/145 Adverse events are reported for randomized population.	5.6% 8/144 Adverse events are reported for randomized population.
General disorders FATIGUE	18.6% 27/145 Adverse events are reported for randomized population.	16.7% 24/144 Adverse events are reported for randomized population.
General disorders PYREXIA	4.1% 6/145 Adverse events are reported for randomized population.	6.9% 10/144 Adverse events are reported for randomized population.
General disorders ASTHENIA	9.0% 13/145 Adverse events are reported for randomized population.	6.9% 10/144 Adverse events are reported for randomized population.
General disorders MUCOSAL INFLAMMATION	6.2% 9/145 Adverse events are reported for randomized population.	1.4% 2/144 Adverse events are reported for randomized population.