SWOG-8814 Tamoxifen With or Without Combination Chemotherapy in Postmenopausal Women Who Have Undergone Surgery for Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: endocrine therapyDrug: cyclophosphamideDrug: doxorubicin hydrochlorideRadiation: brachytherapyRadiation: low-LET electron therapyDrug: endocrine-modulating drug therapyRadiation: low-LET photon therapyDrug: fluorouracilDrug: tamoxifen citrateRadiation: radiation therapy
- Registration Number
- NCT00929591
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen alone is more effective in treating breast cancer than giving tamoxifen together with chemotherapy or after chemotherapy.
PURPOSE: This randomized phase III trial is studying giving tamoxifen with or without combination chemotherapy to compare how well they work in treating postmenopausal women who have undergone surgery for breast cancer.
- Detailed Description
OBJECTIVES: I. Compare disease-free survival and overall survival of postmenopausal women with node-positive, estrogen and/or progesterone receptor-positive adenocarcinoma of the breast randomly assigned to postoperative adjuvant treatment with long-term (5 years) tamoxifen vs. CAF (cyclophosphamide/doxorubicin/fluorouracil) plus concurrent and long-term tamoxifen vs. CAF followed by long-term tamoxifen. II. Compare the relative toxicities of these three regimens.
OUTLINE: Randomized study. All patients are randomized on Arms I, II, and III. Lumpectomy patients must receive radiotherapy on Regimen A. At the discretion of the physician, mastectomy patients may receive radiotherapy on Regimen B for a tumor greater than 5 cm in diameter, 4 or more positive nodes, or extranodal extension of the tumor into the axillary fat. Patients randomized to Arm I who are to receive radiotherapy should begin as soon as feasible postoperatively; these patients may be irradiated while receiving tamoxifen. Patients on Arms II and III who are to receive radiotherapy are treated either postoperatively prior to registration or after completion of and recovery from 6 courses of CAF. Arm I: Antiestrogen Therapy. Tamoxifen, TMX, NSC-180973. Arm II: 3-Drug Combination Chemotherapy followed by Antiestrogen Therapy. CAF: Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Fluorouracil, 5-FU, NSC-19893; followed by TMX. Arm III: 3-Drug Combination Chemotherapy plus Concurrent Antiestrogen Therapy. CAF; plus concurrent TMX. Regimen A: Radiotherapy. Irradiation of the breast and underlying chest wall and (optionally) of the supraclavicular area and, if indicated, the axilla, using megavoltage equipment with photon energies of up to 6 MV followed, if indicated, by a tumor bed boost using either electrons or iridium-192 (192-Ir) implants. Regimen B: Radiotherapy. Irradiation of the chest wall using either megavoltage photons via a tangential field or electrons via a direct field plus (optional) photon irradiation of the supraclavicular area and, if indicated, the axilla.
PROJECTED ACCRUAL: 350 patients will be randomized to Arm I and 530 patients each will be randomized to Arms II and III. Accrual should be completed in about 4 years, and 4 additional years will be required for follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1558
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAF followed by tamoxifen for five years tamoxifen citrate intermittent CAF X 6 courses followed by tamoxifen for five years tamoxifen for five years endocrine therapy tamoxifen for five years tamoxifen for five years tamoxifen citrate tamoxifen for five years tamoxifen for five years brachytherapy tamoxifen for five years tamoxifen for five years low-LET electron therapy tamoxifen for five years tamoxifen for five years low-LET photon therapy tamoxifen for five years tamoxifen for five years radiation therapy tamoxifen for five years CAF followed by tamoxifen for five years endocrine therapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years endocrine-modulating drug therapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years brachytherapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years low-LET electron therapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years low-LET photon therapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years radiation therapy intermittent CAF X 6 courses followed by tamoxifen for five years CAF with concurrent tamoxifen for five years doxorubicin hydrochloride intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years endocrine therapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years endocrine-modulating drug therapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years tamoxifen citrate intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years brachytherapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years low-LET electron therapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years low-LET photon therapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years radiation therapy intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF followed by tamoxifen for five years cyclophosphamide intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years doxorubicin hydrochloride intermittent CAF X 6 courses followed by tamoxifen for five years CAF followed by tamoxifen for five years fluorouracil intermittent CAF X 6 courses followed by tamoxifen for five years CAF with concurrent tamoxifen for five years cyclophosphamide intermittent CAF X 6 courses with concurrent tamoxifen for five years CAF with concurrent tamoxifen for five years fluorouracil intermittent CAF X 6 courses with concurrent tamoxifen for five years
- Primary Outcome Measures
Name Time Method Disease-free survival eight years Overall survival eight years Toxicity/morbidity of treatment during treatment
- Secondary Outcome Measures
Name Time Method