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

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ClinicalTrials.gov Identifier: NCT00050167

Recruitment Status : Completed

First Posted : November 27, 2002

Results First Posted : August 5, 2011

Last Update Posted : August 29, 2011

Sponsor:

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Paclitaxel Drug: Docetaxel Drug: Capecitabine
Enrollment	603

Participant Flow

Recruitment Details	Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details	Planned accrual was 930 participants, only 601 were found eligible.


Arm/Group Title	Weekly Paclitaxel (WP)	Docetaxel and Capecitabine (DX)
Arm/Group Description	Weekly Paclitaxel for 12 weeks foll...	Docetaxel + Capecitabine days 1-14 ...
Arm/Group Description	Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Period Title: Overall Study
Started	302	301
Completed	301	300
Not Completed	1	1
Reason Not Completed
not eligible not invasive	1	1

Baseline Characteristics

Arm/Group Title		Weekly Paclitaxel (WP)	Docetaxel and Capecitabine (DX)	Total
Arm/Group Description		Weekly Paclitaxel for 12 weeks foll...	Docetaxel + Capecitabine days 1-14 ...	Total of all reporting groups
Arm/Group Description		Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.	Total of all reporting groups
Overall Number of Baseline Participants		302	301	603
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	302 participants	301 participants	603 participants
		50 (42 to 57)	50 (42 to 57)	50 (42 to 57)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	302 participants	301 participants	603 participants
	Female	302 100.0%	301 100.0%	603 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	302 participants	301 participants	603 participants
United States		302	301	603

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Reoccurrence
Description	Percentage of participants where number with local recurrence, distant...
Description	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).
Time Frame	Median of 50 months

Outcome Measure Data

Analysis Population Description

(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.


Arm/Group Title	Weekly Paclitaxel (WP)	Docetaxel and Capecitabine (DX)
Arm/Group Description:	Weekly Paclitaxel for 12 weeks foll...	Docetaxel + Capecitabine days 1-14 ...
Arm/Group Description:	Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Overall Number of Participants Analyzed	301	300
Log Mean (95% Confidence Interval) Unit of Measure: participants
	90.7 (86.4 to 93.7)	87.5 (82.7 to 91.1)

2.Secondary Outcome


Title	Proportion of Participants With Pathological Complete Response
Description	Safety of 2 Different Treatments determined by proportion of participa...
Description	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.
Time Frame	7 Years

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes
Description	Effectiveness defined as proportion of patients who were able to have ...
Description	Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.
Time Frame	7 years

Outcome Measure Data Not Reported

Adverse Events

Time Frame	8 years and 5 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Weekly Paclitaxel (WP)		Docetaxel and Capecitabine (DX)
Arm/Group Description	Weekly Paclitaxel for 12 weeks foll...		Docetaxel + Capecitabine days 1-14 ...
Arm/Group Description	Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles		Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
All-Cause Mortality
	Weekly Paclitaxel (WP)		Docetaxel and Capecitabine (DX)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Weekly Paclitaxel (WP)		Docetaxel and Capecitabine (DX)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/301 (26.91%)		293/300 (97.67%)
Blood and lymphatic system disorders
Neutropenia ^† 1	2/297 (0.67%)	2	45/293 (15.36%)	45
Cardiac disorders
Fluid retention ^† 1	1/297 (0.34%)	1	0/293 (0.00%)	0
Gastrointestinal disorders
Nausea ^† 1	5/297 (1.68%)	5	12/293 (4.10%)	12
Vomiting ^† 1	0/297 (0.00%)	0	5/293 (1.71%)	5
Diarrhea ^† 1	12/297 (4.04%)	12	17/293 (5.80%)	17
Constipation ^† 1	2/297 (0.67%)	2	6/293 (2.05%)	6
General disorders
Fatigue ^† 1	25/297 (8.42%)	25	66/293 (22.53%)	66
Alopecia ^† 1	0/297 (0.00%)	0	0/293 (0.00%)	0
Immune system disorders
Allergic reaction ^† 1	2/297 (0.67%)	2	4/293 (1.37%)	4
Infections and infestations
Stomatitis ^† 1	0/297 (0.00%)	0	5/293 (1.71%)	5
Neutropenic Infection ^† 1	2/297 (0.67%)	2	20/293 (6.83%)	20
Neutropenic Fever ^† 1	0/297 (0.00%)	0	13/293 (4.44%)	13
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/297 (0.00%)	0	3/293 (1.02%)	3
Myalgia ^† 1	19/297 (6.40%)	19	32/293 (10.92%)	32
Nervous system disorders
Peripheral Neurotoxicity ^† 1	7/297 (2.36%)	7	14/293 (4.78%)	14
Skin and subcutaneous tissue disorders
Skin rash ^† 1	3/297 (1.01%)	3	1/293 (0.34%)	1
Hand foot syndrome ^† 1	1/297 (0.34%)	1	54/293 (18.43%)	54
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE (2.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Weekly Paclitaxel (WP)		Docetaxel and Capecitabine (DX)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	297/301 (98.67%)		293/300 (97.67%)
Blood and lymphatic system disorders
Neutropenia ^† 1	30/297 (10.10%)	30	9/293 (3.07%)	9
Neutropenic Infection ^† 1	0/297 (0.00%)	0	0/293 (0.00%)	0
Fluid Retention ^† 1	3/297 (1.01%)	3	8/293 (2.73%)	8
Gastrointestinal disorders
Nausea ^† 1	64/297 (21.55%)	64	131/293 (44.71%)	131
Vomiting ^† 1	24/297 (8.08%)	24	41/293 (13.99%)	41
Stomatitis ^† 1	31/297 (10.44%)	31	118/293 (40.27%)	118
Diarrhea ^† 1	55/297 (18.52%)	55	85/293 (29.01%)	85
Constipation ^† 1	27/297 (9.09%)	27	50/293 (17.06%)	50
General disorders
fatigue ^† 1	146/297 (49.16%)	146	169/293 (57.68%)	169
Immune system disorders
Allergic reaction ^† 1	4/297 (1.35%)	4	6/293 (2.05%)	6
Infections and infestations
Neutropenic Fever ^† 1	0/297 (0.00%)	0	0/293 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	10/297 (3.37%)	10	20/293 (6.83%)	20
Myalgias ^† 1	109/297 (36.70%)	109	137/293 (46.76%)	137
Nervous system disorders
Peripheral Neurotoxicity ^† 1	68/297 (22.90%)	68	64/293 (21.84%)	64
Skin and subcutaneous tissue disorders
Alopecia ^† 1	239/297 (80.47%)	239	266/293 (90.78%)	266
Skin rash ^† 1	77/297 (25.93%)	77	43/293 (14.68%)	43
Hand Foot Syndrome ^† 1	5/297 (1.68%)	5	72/293 (24.57%)	72
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE (2.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Aman Buzdar, M.D./Professor
Organization:	UT MD Anderson Cancer Center
EMail:	agmadrig@mail.mdanderson.org

Layout table for additonal information

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050167
Other Study ID Numbers:	ID01-580
First Submitted:	November 25, 2002
First Posted:	November 27, 2002
Results First Submitted:	July 7, 2011
Results First Posted:	August 5, 2011
Last Update Posted:	August 29, 2011

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