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Brief Title † | Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer | ||||||||||||||||||||
Official Title † | Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node Positive or High-Risk Node Negative Breast Cancer | ||||||||||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (0 vs 1-3 positive nodes by axillary nodal dissection vs 4-9 positive nodes by axillary nodal dissection vs at least 10 positive nodes by axillary nodal dissection vs positive sentinel node with no or negative axillary nodal dissection vs negative sentinel node with no axillary nodal dissection vs node negative by axillary nodal dissection) and receptor status (estrogen receptor [ER] or progesterone receptor [PR] positive vs other). Patients are randomized to 1 of 3 treatment arms.
NOTE: *Patients who completed paclitaxel on or after October 25, 2004 may receive trastuzumab for a maximum of 52 weeks either concurrently with paclitaxel or following completion of paclitaxel treatment.
NOTE: *Patients who completed paclitaxel on or after October 25, 2004 may receive trastuzumab for a maximum of 52 weeks either concurrently with paclitaxel or following completion of paclitaxel treatment.
Within 5 weeks after completion of paclitaxel, patients may undergo radiotherapy. All postmenopausal ER- or PR-positive patients receive oral tamoxifen or an aromatase inhibitor once daily for 5 years beginning no later than 5 weeks after the last dose of paclitaxel. Patients may also receive an aromatase inhibitor once daily for 5 years after 5 years of daily tamoxifen. Patients who receive tamoxifen once daily for less than 4.5 years may receive an aromatase inhibitor daily until they have received a total of 5 years of adjuvant hormonal therapy. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 15 years or until disease progression. PROJECTED ACCRUAL: A total of 3,700 patients (at least 1,150 for arms I and II and at least 1,000 for arm III) will be accrued for this study within approximately 5.75 years. |
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Study Phase | Phase III | ||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||
Study Design † | Treatment, Randomized, Active Control | ||||||||||||||||||||
Primary Outcome Measure † | |||||||||||||||||||||
Secondary Outcome Measure † | |||||||||||||||||||||
Condition † | Breast Cancer | ||||||||||||||||||||
Intervention † | Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Drug: trastuzumab Procedure: adjuvant therapy Procedure: aromatase inhibition therapy |
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MEDLINE PMIDs | 18250349, 16809727, 15365066, 12048274, 18757259, 18543100, 17592827, 17308268, 17308267, 17687157, 16971734, 16236738, 14722042 | ||||||||||||||||||||
Links | Clinical trial summary from the National Cancer Institute's PDQ® database  | ||||||||||||||||||||
Recruitment Information Fields | |||||||||||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||||||||||
Enrollment † | |||||||||||||||||||||
Start Date † | May 2000 | ||||||||||||||||||||
Completion Date | |||||||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Female | ||||||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||
Contacts †† | |||||||||||||||||||||
Location Countries † | United States, Canada, Peru, South Africa | ||||||||||||||||||||
Administrative Information Fields | |||||||||||||||||||||
NCT ID † | NCT00005970 | ||||||||||||||||||||
Organization ID | CDR0000067953 | ||||||||||||||||||||
Secondary IDs †† | NCCTG-N9831, CALGB-49909, ECOG-N9831, SWOG-N9831, GUMC-00224, CAN-NCIC-MA28 | ||||||||||||||||||||
Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||||||||||
Collaborators †† | National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group National Cancer Institute of Canada |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
Verification Date | January 2006 | ||||||||||||||||||||
First Received Date † | July 5, 2000 | ||||||||||||||||||||
Last Updated Date | January 7, 2009 |