Doxorubicin or Epirubicin and Cyclophosphamide in Treating Older Women With Invasive Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving doxorubicin or epirubicin together with cyclophosphamide is more effective than observation in treating older women with invasive breast cancer.

PURPOSE: This randomized phase III trial is studying doxorubicin or epirubicin and cyclophosphamide to see how well they work compared with observation in treating older women with invasive breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charing Cross Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Epirubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast carcinoma

• Primary operable breast cancer that was surgically treated by wide local excision or mastectomy with clear margins (> 1 mm apart from deep margin if full thickness resection)

• No more than 8 weeks since prior definitive surgery

• Early-stage disease with no evidence of metastases clinically or on routine staging investigations

• No T4 and/or N3 disease

• Prior axillary staging required, including 1 of the following:

• Sentinel node biopsy

• Axillary sampling or clearance

• All node-positive patients must have had axillary clearance or radiotherapy to the axilla

• Must be at high risk of relapse within 5 years (risk factors evaluated at clinician's discretion)

• No other invasive breast cancer, systemically treated ductal carcinoma in situ (DCIS), or solid tumor within the past 5 years

• No prior hematologic malignancy or melanoma

• Hormone receptor status:

• Estrogen receptor (ER)- or progesterone receptor (PR)-negative OR ER/PR-weakly positive (e.g., Allred/Quick score ≤ 5 OR H score ≤ 100)

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

• Performance status 0-1

• Hemoglobin > 9 g/dL

• WBC > 3,000/mm³

• Platelet count > 100,000/mm³

• Bilirubin normal (unless known Gilbert's disease is present)

• Albumin normal

• AST and ALT ≤ 1.5 x upper limit of normal (ULN)

• Creatinine ≤ 1.5 x ULN

• Creatinine clearance > 50 mL/min

• No active or uncontrolled infection

• Must be available for routine long-term hospital follow-up

• Must have normal cardiac function and no significant cardiac disease by ECHO or MUGA

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior preoperative endocrine therapy

• No prior systemic therapy for this breast cancer or mantle radiotherapy

• No prior breast-conserving surgery in which there is a contraindication for, or decline of postoperative radiotherapy

• No concurrent hormone replacement therapy (HRT)