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Sponsored by: |
University of York |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301925 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: capecitabine Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate Drug: pegfilgrastim Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2) |
Estimated Enrollment: | 4400 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | September 2024 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histological diagnosis of invasive breast carcinoma
Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks
Negative surgical margins required, unless either of the following are true:
No prior or current invasive breast cancer or bilateral breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following:
Study Chair: | David Cameron, MD | National Cancer Research Network |
Study ID Numbers: | CDR0000463447, ICR-TACT2, EU-205114, EUDRACT-2004-000066-13, MREC-04/MRE00/88, ISRCTN68068041 |
Study First Received: | March 9, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00301925 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer male breast cancer |
Folic Acid Capecitabine Skin Diseases Breast Neoplasms, Male Fluorouracil |
Methotrexate Breast Neoplasms Cyclophosphamide Epirubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |