Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Institute of Cancer Research, United Kingdom

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: tamoxifen citrate; Drug: fluorouracil; Drug: methotrexate; Drug: CMF regimen; Drug: goserelin acetate; Radiation: radiation therapy; Drug: doxorubicin hydrochloride; Drug: cyclophosphamide; Procedure: oophorectomy; Drug: leuprolide acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00002582

YRCO-ABC

CDR0000063697 (Registry Identifier)

CRC-TU-BR3010

UKCCCR-ABC

SCTN-BR9401/BR9402

EU-94029

NCRI-ABC

Details and patient eligibility

About

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

Full description

OBJECTIVES:

• Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group).

• First group: Patients receive tamoxifen by mouth every day for 5 years.
• Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses.
• Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin.
• Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC.

Patients are followed for overall and relapse-free survival.

PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study.

Enrollment: 6,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate

  • Stage I, II, or IIIA
  • Pathologically positive or negative nodes
  • Any size primary tumor

• No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• Not specified

Sex:

• Female

Menopausal status:

• Pre-, peri-, or postmenopausal

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No prior malignancy except:

  • Basal cell carcinoma
  • Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior systemic treatment for breast cancer