Trial Outcomes & Findings for Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer (NCT NCT00274456)

Last Updated: 2019-11-21

Results Overview

Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is \>= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

302 participants

Primary outcome timeframe

Day 1 up to 95 weeks

Results posted on

2019-11-21

Participant Flow

Three hundred and two patients were enrolled and randomized between November 2005 and June 2006, of which 300 received study drug and were evaluated for response and safety. Data below represents data cut-off 31 March 2008.

Participant milestones

Participant milestones
Measure	ABI-007 300 mg/m^2 q3w ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Overall Study STARTED	76	76	74	74
Overall Study At Least One Response Assessment	73	76	73	70
Overall Study COMPLETED	39	49	39	29
Overall Study NOT COMPLETED	37	27	35	45

Reasons for withdrawal

Reasons for withdrawal
Measure	ABI-007 300 mg/m^2 q3w ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Overall Study Still on treatment	2	3	5	1
Overall Study Unacceptable toxicity	10	5	12	16
Overall Study Adverse Event	0	1	2	2
Overall Study Physician Decision	7	5	6	13
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Withdrawal by Subject	18	13	9	13

Baseline Characteristics

Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest.	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).	Total n=300 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 9.47 • n=5 Participants	55.4 years STANDARD_DEVIATION 9.59 • n=7 Participants	53.3 years STANDARD_DEVIATION 9.14 • n=5 Participants	55.4 years STANDARD_DEVIATION 11.57 • n=4 Participants	53.9 years STANDARD_DEVIATION 10.05 • n=21 Participants
Age, Customized >=65 years	9 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants	52 Participants n=21 Participants
Age, Customized <65 years	67 Participants n=5 Participants	62 Participants n=7 Participants	64 Participants n=5 Participants	55 Participants n=4 Participants	248 Participants n=21 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	76 Participants n=7 Participants	74 Participants n=5 Participants	74 Participants n=4 Participants	300 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White, Non-Hispanic, Non-Latino	74 Participants n=5 Participants	75 Participants n=7 Participants	74 Participants n=5 Participants	74 Participants n=4 Participants	297 Participants n=21 Participants
Race/Ethnicity, Customized White, Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Weight	72.56 Kg STANDARD_DEVIATION 12.668 • n=5 Participants	73.64 Kg STANDARD_DEVIATION 14.670 • n=7 Participants	76.24 Kg STANDARD_DEVIATION 13.437 • n=5 Participants	75.99 Kg STANDARD_DEVIATION 14.034 • n=4 Participants	74.59 Kg STANDARD_DEVIATION 13.742 • n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (fully active)	34 participants n=5 Participants	33 participants n=7 Participants	24 participants n=5 Participants	28 participants n=4 Participants	119 participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (restrictive but ambulatory)	35 participants n=5 Participants	39 participants n=7 Participants	45 participants n=5 Participants	44 participants n=4 Participants	163 participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (ambulatory but unable to work)	7 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	18 participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 (limited self-care) + 4 (completely disabled)	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Menopausal Status Pre-menopausal	26 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants	12 Participants n=4 Participants	73 Participants n=21 Participants
Menopausal Status Post-menopausal	49 Participants n=5 Participants	62 Participants n=7 Participants	53 Participants n=5 Participants	60 Participants n=4 Participants	224 Participants n=21 Participants
Menopausal Status Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Physician Assessment of Sensory Neuropathy Grade 0	67 Participants n=5 Participants	70 Participants n=7 Participants	65 Participants n=5 Participants	67 Participants n=4 Participants	269 Participants n=21 Participants
Physician Assessment of Sensory Neuropathy Grade 1	9 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	31 Participants n=21 Participants
Time from Primary Diagnosis and from First Metastasis/Relapse to Study Entry Time from Primary Diagnosis to Study Entry	1.24 Years n=5 Participants	1.17 Years n=7 Participants	0.97 Years n=5 Participants	1.27 Years n=4 Participants	1.23 Years n=21 Participants
Time from Primary Diagnosis and from First Metastasis/Relapse to Study Entry Time from First Metastasis/Relapse to Study Entry	0.02 Years n=5 Participants	0.04 Years n=7 Participants	0.05 Years n=5 Participants	0.04 Years n=4 Participants	0.04 Years n=21 Participants
Current Site of Metastasis/Relapse Breast	10 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	42 Participants n=21 Participants
Current Site of Metastasis/Relapse Skin/Soft Tissue	16 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants	68 Participants n=21 Participants
Current Site of Metastasis/Relapse Supraclavicular	23 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	25 Participants n=4 Participants	93 Participants n=21 Participants
Current Site of Metastasis/Relapse Axilla	43 Participants n=5 Participants	48 Participants n=7 Participants	47 Participants n=5 Participants	44 Participants n=4 Participants	182 Participants n=21 Participants
Current Site of Metastasis/Relapse Lung/Thoracic	53 Participants n=5 Participants	49 Participants n=7 Participants	51 Participants n=5 Participants	58 Participants n=4 Participants	211 Participants n=21 Participants
Current Site of Metastasis/Relapse Hepatic/Liver	21 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	25 Participants n=4 Participants	97 Participants n=21 Participants
Current Site of Metastasis/Relapse Abdomen/Peritoneal	12 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	34 Participants n=21 Participants
Current Site of Metastasis/Relapse Pelvis	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Current Site of Metastasis/Relapse Bone	22 Participants n=5 Participants	25 Participants n=7 Participants	33 Participants n=5 Participants	25 Participants n=4 Participants	105 Participants n=21 Participants
Current Site of Metastasis/Relapse Other	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Dominant Current Site of Metastasis/Relapse Visceral	64 Participants n=5 Participants	61 Participants n=7 Participants	59 Participants n=5 Participants	67 Participants n=4 Participants	251 Participants n=21 Participants
Dominant Current Site of Metastasis/Relapse Non-visceral	12 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	49 Participants n=21 Participants
Stage at Primary Diagnosis Stage I	2 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	11 participants n=21 Participants
Stage at Primary Diagnosis Stage IIa	11 participants n=5 Participants	13 participants n=7 Participants	11 participants n=5 Participants	13 participants n=4 Participants	48 participants n=21 Participants
Stage at Primary Diagnosis Stage IIb	12 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants	15 participants n=4 Participants	47 participants n=21 Participants
Stage at Primary Diagnosis Stage IIIa	11 participants n=5 Participants	10 participants n=7 Participants	7 participants n=5 Participants	6 participants n=4 Participants	34 participants n=21 Participants
Stage at Primary Diagnosis Stage IIIb	14 participants n=5 Participants	14 participants n=7 Participants	9 participants n=5 Participants	13 participants n=4 Participants	50 participants n=21 Participants
Stage at Primary Diagnosis Stage IIIc	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Stage at Primary Diagnosis Stage IV	23 participants n=5 Participants	25 participants n=7 Participants	28 participants n=5 Participants	21 participants n=4 Participants	97 participants n=21 Participants
Stage at Primary Diagnosis Unknown	3 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	10 participants n=21 Participants
Number of Lesions (Target + Non-Target) 0 lesions	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Number of Lesions (Target + Non-Target) 1 lesion	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Number of Lesions (Target + Non-Target) 2-3 lesions	11 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	40 Participants n=21 Participants
Number of Lesions (Target + Non-Target) >3 lesions	63 Participants n=5 Participants	62 Participants n=7 Participants	67 Participants n=5 Participants	60 Participants n=4 Participants	252 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 up to 95 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator Independent reader assessed ORR	37 percentage of participants Interval 26.0 to 47.7	45 percentage of participants Interval 33.6 to 55.9	49 percentage of participants Interval 37.3 to 60.0	35 percentage of participants Interval 24.3 to 46.0
Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator Investigator assessed ORR	46 percentage of participants Interval 34.8 to 57.3	63 percentage of participants Interval 52.3 to 74.0	74 percentage of participants Interval 64.4 to 84.3	39 percentage of participants Interval 28.1 to 50.3

SECONDARY outcome

Timeframe: Day 1 up to 95 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug

Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response Independent Assessed SD Disease Control	68 percentage of participants Interval 58.0 to 78.9	75 percentage of participants Interval 65.3 to 84.7	80 percentage of participants Interval 70.6 to 88.9	58 percentage of participants Interval 46.9 to 69.3
Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response Investigator Assessed Disease Control	72 percentage of participants Interval 62.3 to 82.4	83 percentage of participants Interval 74.4 to 91.4	91 percentage of participants Interval 83.9 to 97.2	69 percentage of participants Interval 58.4 to 79.5

SECONDARY outcome

Timeframe: Day 1 up to 95 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug

PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Kaplan-Meier Estimates for Progression-free Survival (PFS) Independent Assessment for PFS	11.0 months Interval 7.3 to 15.0	12.8 months Interval 9.0 to 14.7	12.9 months Interval 10.9 to 16.6	7.5 months Interval 7.2 to 9.0
Kaplan-Meier Estimates for Progression-free Survival (PFS) Investigator Assessment for PFS	10.9 months Interval 8.9 to 14.6	7.5 months Interval 7.2 to 9.3	14.6 months Interval 10.0 to 18.9	7.8 months Interval 6.3 to 11.0

SECONDARY outcome

Timeframe: Day 1 - 95 weeks

Population: Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.

Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=28 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=34 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=36 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=26 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression	13.0 months Interval 11.2 to 23.9	13.2 months Interval 11.3 to 14.9	15.1 months Interval 10.9 to 16.7	9.0 months Interval 7.5 to 14.8

SECONDARY outcome

Timeframe: Day 1 - 95 weeks

Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=35 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=48 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=55 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=29 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression	12.9 months Interval 10.3 to 19.4	9.2 months Interval 7.4 to 12.4	14.8 months Interval 12.8 to 19.2	15.1 months Interval 11.0 to 17.6

SECONDARY outcome

Timeframe: Day 1 to 221 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug

Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Kaplan-Meier Estimate for Overall Survival (OS)	27.7 months Interval 21.7 to 38.9	22.2 months Interval 16.9 to 29.4	33.8 months Interval 29.1 to 41.3	26.6 months Interval 19.0 to 31.3

SECONDARY outcome

Timeframe: Day 1 up to 125 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug

Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=76 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=74 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related AE drug interrupted	1 participants	1 participants	0 participants	1 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >= 1 adverse event (AE)	75 participants	75 participants	73 participants	73 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related AE	74 participants	72 participants	73 participants	72 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 serious AE	14 participants	12 participants	11 participants	56 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related serious AE	13 participants	5 participants	8 participants	55 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 severe (grade 3-5) treatment-related AE	47 participants	30 participants	49 participants	71 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events Grade 3-5 Neutropenia	33 participants	19 participants	33 participants	68 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events Grade 3-5 Febrile neutropenia	1 participants	1 participants	1 participants	8 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events Grade 3-5 Sensory neuropathy	16 participants	7 participants	16 participants	9 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 AE with outcome of death	0 participants	1 participants	2 participants	2 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related AE with outcome of death	0 participants	0 participants	0 participants	2 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related AE drug discontinued	10 participants	5 participants	12 participants	16 participants
Participants With Treatment-Emergent, Treatment-Related Adverse Events >=1 treatment-related AE drug dosage reduced	14 participants	13 participants	35 participants	21 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to 125 weeks

Population: The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.

Maximal degree of myelosuppression is represented by the nadir in absolute neutrophil (ANC), white blood cell (WBC), and platelet measurements over all treatment cycles.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=75 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=72 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts ANC	1.21 10^9/L Standard Deviation 1.004	1.51 10^9/L Standard Deviation 0.960	1.11 10^9/L Standard Deviation 0.628	0.38 10^9/L Standard Deviation 0.339
Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts WBC	2.88 10^9/L Standard Deviation 1.187	3.15 10^9/L Standard Deviation 1.228	2.68 10^9/L Standard Deviation 0.817	1.60 10^9/L Standard Deviation 0.726
Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts Platelet	182.1 10^9/L Standard Deviation 59.16	192.1 10^9/L Standard Deviation 57.82	172.6 10^9/L Standard Deviation 46.39	161.8 10^9/L Standard Deviation 49.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to 125 weeks

Maximal degree of myelosuppression is represented by the nadir in hemoglobin (Hb) measurements over all treatment cycles.

Outcome measures

Outcome measures
Measure	ABI-007 300 mg/m^2 q3w n=75 Participants ABI-007 300 mg/m\^2 administered once every third week (q3w).	ABI-007 100 mg/m^2 Weekly n=76 Participants ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	ABI-007 150 mg/m^2 Weekly n=74 Participants ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest	Docetaxel 100 mg/m^2 q3w n=72 Participants Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).
Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts	112.1 g/L Standard Deviation 10.58	106.7 g/L Standard Deviation 10.72	105.6 g/L Standard Deviation 11.31	107.1 g/L Standard Deviation 13.39

Adverse Events

ABI-007 300 mg/m^2 q3w

Serious events: 14 serious events

Other events: 75 other events

Deaths: 0 deaths

ABI-007 100 mg/m^2 Weekly

Serious events: 12 serious events

Other events: 75 other events

Deaths: 0 deaths

ABI-007 150 mg/m^2 Weekly

Serious events: 11 serious events

Other events: 73 other events

Deaths: 0 deaths

Docetaxel 100 mg/m^2 q3w

Serious events: 56 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications of this multicenter trial should include input from INVESTIGATORS, his/her colleagues, and SPONSOR personnel. Such input should be reflected in publication authorship, and agreement regarding order of authors should be established before writing a manuscript. Subsequent to the multicenter publication or one year after completion of the study, whichever occurs first, an investigator and/or his/her colleagues may publish the results of INVESTIGATOR's part of the study independently.
Publication restrictions are in place

Restriction type: OTHER