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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group NCIC Clinical Trials Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005970 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: aromatase inhibition therapy Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Study Start Date: | May 2000 |
Hide Detailed DescriptionOBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed operable adenocarcinoma of the breast, meeting 1 of the following criteria:
Node-positive disease, meeting the following criteria:
High-risk node-negative disease, meeting the following criteria:
Node-negative as determined by 1 of the following:
HER-2 positive
No locally advanced (T4) tumors at diagnosis, including:
No bilateral invasive carcinoma or DCIS (metachronous or synchronous)
No more than 84 days since prior mastectomy or axillary or sentinel node dissection
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 210 Study Locations| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
| Study Chair: | Nancy E. Davidson, MD | Sidney Kimmel Comprehensive Cancer Center |
| Study Chair: | Peter A. Kaufman, MD | Norris Cotton Cancer Center |
| Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
| Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
More Information
| Study ID Numbers: | CDR0000067953, NCCTG-N9831, CALGB-49909, ECOG-N9831, SWOG-N9831, GUMC-00224, CAN-NCIC-MA28 |
| Study First Received: | July 5, 2000 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005970 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses Trastuzumab Alkylating Agents |
Breast Diseases Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Tamoxifen Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Paclitaxel Tubulin Modulators |