Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells.

PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Amgen; National Cancer Institute (NCI); Pharmacia
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage I, II, or III

• Inflammatory breast cancer allowed

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin normal

• SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR

• SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN

Renal

• Not specified

Cardiovascular

• LVEF at least lower limit of normal by MUGA or echocardiogram

• No unstable angina

• No congestive heart failure

• No arrhythmia requiring medical therapy

• No myocardial infarction within the past year

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL

• No psychiatric illness that would preclude understanding of the nature of the study or study compliance

• No active unresolved infection

• No peripheral neuropathy greater than grade 1

• No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No concurrent medical condition that would preclude study participation in the judgment of the investigator

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 12 months since prior immunotherapy for prior breast cancer

• No prior or concurrent biologic therapy or immunotherapy for this breast cancer

Chemotherapy

• More than 12 months since prior chemotherapy for prior breast cancer

• No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy

• No prior or other concurrent chemotherapy for this breast cancer

Endocrine therapy

• No concurrent hormonal therapy for chemoprevention

• Prior hormonal therapy for chemoprevention allowed

• No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy)

Radiotherapy

• No prior radiotherapy

• No other concurrent radiotherapy for this breast cancer

Surgery

• Not specified

Other

• No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure