Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery (TACT2)
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ClinicalTrials.gov Identifier: NCT00301925 |
Recruitment Status :
Active, not recruiting
First Posted : March 13, 2006
Last Update Posted : August 8, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | March 9, 2006 | |||
First Posted Date ICMJE | March 13, 2006 | |||
Last Update Posted Date | August 8, 2018 | |||
Actual Study Start Date ICMJE | December 16, 2005 | |||
Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Disease-free survival (DFS) at 5 years | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery | |||
Official Title ICMJE | Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2) | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment continues in the absence of unacceptable toxicity. Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years. Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization. After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK. PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
4400 | |||
Original Enrollment ICMJE | Not Provided | |||
Estimated Study Completion Date ICMJE | September 2024 | |||
Estimated Primary Completion Date | September 2024 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00301925 | |||
Other Study ID Numbers ICMJE | CDR0000463447 ICR-TACT2 EU-205114 EUDRACT-2004-000066-13 MREC-04/MRE00/88 ISRCTN68068041 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Institute of Cancer Research, United Kingdom | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Institute of Cancer Research, United Kingdom | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Institute of Cancer Research, United Kingdom | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |