Trial Outcomes & Findings for Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer (NCT NCT00050167)

Last Updated: 2011-08-29

Results Overview

Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

603 participants

Primary outcome timeframe

Median of 50 months

Results posted on

2011-08-29

Participant Flow

Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.

Planned accrual was 930 participants, only 601 were found eligible.

Participant milestones

Participant milestones
Measure	Weekly Paclitaxel (WP) Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Overall Study STARTED	302	301
Overall Study COMPLETED	301	300
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Weekly Paclitaxel (WP) Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Overall Study not eligible not invasive	1	1

Baseline Characteristics

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weekly Paclitaxel (WP) n=302 Participants Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) n=301 Participants Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.	Total n=603 Participants Total of all reporting groups
Age Continuous	50 years n=5 Participants	50 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	302 Participants n=5 Participants	301 Participants n=7 Participants	603 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	302 participants n=5 Participants	301 participants n=7 Participants	603 participants n=5 Participants

PRIMARY outcome

Timeframe: Median of 50 months

Population: (WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis. (DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis.

Outcome measures

Outcome measures
Measure	Weekly Paclitaxel (WP) n=301 Participants Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) n=300 Participants Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Percentage of Participants With Reoccurrence	90.7 participants Interval 86.4 to 93.7	87.5 participants Interval 82.7 to 91.1

SECONDARY outcome

Timeframe: 7 Years

Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 years

Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.

Outcome measures

Outcome data not reported

Adverse Events

Weekly Paclitaxel (WP)

Serious events: 81 serious events

Other events: 297 other events

Deaths: 0 deaths

Docetaxel and Capecitabine (DX)

Serious events: 293 serious events

Other events: 293 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Weekly Paclitaxel (WP) n=301 participants at risk Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) n=300 participants at risk Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Gastrointestinal disorders Nausea	1.7% 5/297 • Number of events 5 • 8 years and 5 months	4.1% 12/293 • Number of events 12 • 8 years and 5 months
Gastrointestinal disorders Vomiting	0.00% 0/297 • 8 years and 5 months	1.7% 5/293 • Number of events 5 • 8 years and 5 months
Infections and infestations Stomatitis	0.00% 0/297 • 8 years and 5 months	1.7% 5/293 • Number of events 5 • 8 years and 5 months
Gastrointestinal disorders Diarrhea	4.0% 12/297 • Number of events 12 • 8 years and 5 months	5.8% 17/293 • Number of events 17 • 8 years and 5 months
General disorders Fatigue	8.4% 25/297 • Number of events 25 • 8 years and 5 months	22.5% 66/293 • Number of events 66 • 8 years and 5 months
Gastrointestinal disorders Constipation	0.67% 2/297 • Number of events 2 • 8 years and 5 months	2.0% 6/293 • Number of events 6 • 8 years and 5 months
Nervous system disorders Peripheral Neurotoxicity	2.4% 7/297 • Number of events 7 • 8 years and 5 months	4.8% 14/293 • Number of events 14 • 8 years and 5 months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/297 • 8 years and 5 months	1.0% 3/293 • Number of events 3 • 8 years and 5 months
Musculoskeletal and connective tissue disorders Myalgia	6.4% 19/297 • Number of events 19 • 8 years and 5 months	10.9% 32/293 • Number of events 32 • 8 years and 5 months
Blood and lymphatic system disorders Neutropenia	0.67% 2/297 • Number of events 2 • 8 years and 5 months	15.4% 45/293 • Number of events 45 • 8 years and 5 months
Infections and infestations Neutropenic Infection	0.67% 2/297 • Number of events 2 • 8 years and 5 months	6.8% 20/293 • Number of events 20 • 8 years and 5 months
Infections and infestations Neutropenic Fever	0.00% 0/297 • 8 years and 5 months	4.4% 13/293 • Number of events 13 • 8 years and 5 months
General disorders Alopecia	0.00% 0/297 • 8 years and 5 months	0.00% 0/293 • 8 years and 5 months
Skin and subcutaneous tissue disorders Skin rash	1.0% 3/297 • Number of events 3 • 8 years and 5 months	0.34% 1/293 • Number of events 1 • 8 years and 5 months
Skin and subcutaneous tissue disorders Hand foot syndrome	0.34% 1/297 • Number of events 1 • 8 years and 5 months	18.4% 54/293 • Number of events 54 • 8 years and 5 months
Immune system disorders Allergic reaction	0.67% 2/297 • Number of events 2 • 8 years and 5 months	1.4% 4/293 • Number of events 4 • 8 years and 5 months
Cardiac disorders Fluid retention	0.34% 1/297 • Number of events 1 • 8 years and 5 months	0.00% 0/293 • 8 years and 5 months

Other adverse events

Other adverse events
Measure	Weekly Paclitaxel (WP) n=301 participants at risk Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel and Capecitabine (DX) n=300 participants at risk Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Gastrointestinal disorders Nausea	21.5% 64/297 • Number of events 64 • 8 years and 5 months	44.7% 131/293 • Number of events 131 • 8 years and 5 months
Gastrointestinal disorders Vomiting	8.1% 24/297 • Number of events 24 • 8 years and 5 months	14.0% 41/293 • Number of events 41 • 8 years and 5 months
Gastrointestinal disorders Stomatitis	10.4% 31/297 • Number of events 31 • 8 years and 5 months	40.3% 118/293 • Number of events 118 • 8 years and 5 months
Gastrointestinal disorders Diarrhea	18.5% 55/297 • Number of events 55 • 8 years and 5 months	29.0% 85/293 • Number of events 85 • 8 years and 5 months
General disorders fatigue	49.2% 146/297 • Number of events 146 • 8 years and 5 months	57.7% 169/293 • Number of events 169 • 8 years and 5 months
Gastrointestinal disorders Constipation	9.1% 27/297 • Number of events 27 • 8 years and 5 months	17.1% 50/293 • Number of events 50 • 8 years and 5 months
Nervous system disorders Peripheral Neurotoxicity	22.9% 68/297 • Number of events 68 • 8 years and 5 months	21.8% 64/293 • Number of events 64 • 8 years and 5 months
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 10/297 • Number of events 10 • 8 years and 5 months	6.8% 20/293 • Number of events 20 • 8 years and 5 months
Musculoskeletal and connective tissue disorders Myalgias	36.7% 109/297 • Number of events 109 • 8 years and 5 months	46.8% 137/293 • Number of events 137 • 8 years and 5 months
Blood and lymphatic system disorders Neutropenia	10.1% 30/297 • Number of events 30 • 8 years and 5 months	3.1% 9/293 • Number of events 9 • 8 years and 5 months
Blood and lymphatic system disorders Neutropenic Infection	0.00% 0/297 • 8 years and 5 months	0.00% 0/293 • 8 years and 5 months
Infections and infestations Neutropenic Fever	0.00% 0/297 • 8 years and 5 months	0.00% 0/293 • 8 years and 5 months
Skin and subcutaneous tissue disorders Alopecia	80.5% 239/297 • Number of events 239 • 8 years and 5 months	90.8% 266/293 • Number of events 266 • 8 years and 5 months
Skin and subcutaneous tissue disorders Skin rash	25.9% 77/297 • Number of events 77 • 8 years and 5 months	14.7% 43/293 • Number of events 43 • 8 years and 5 months
Skin and subcutaneous tissue disorders Hand Foot Syndrome	1.7% 5/297 • Number of events 5 • 8 years and 5 months	24.6% 72/293 • Number of events 72 • 8 years and 5 months
Immune system disorders Allergic reaction	1.3% 4/297 • Number of events 4 • 8 years and 5 months	2.0% 6/293 • Number of events 6 • 8 years and 5 months
Blood and lymphatic system disorders Fluid Retention	1.0% 3/297 • Number of events 3 • 8 years and 5 months	2.7% 8/293 • Number of events 8 • 8 years and 5 months

Additional Information

Aman Buzdar, M.D./Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place