Paclitaxel, Doxorubicin, and Cyclophosphamide With Or Without Carboplatin in Treating Women With Locally Advanced Breast Cancer That Can Be Removed by Surgery

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

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, cyclophosphamide, and carboplatin, 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 combination chemotherapy is more effective with or without carboplatin in treating breast cancer.

PURPOSE: This randomized phase II trial is studying giving paclitaxel together with doxorubicin and cyclophosphamide to see how well it works compared to giving paclitaxel together with doxorubicin, cyclophosphamide, and carboplatin in treating women with locally advanced breast cancer that can be removed by surgery.

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

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive basal-type breast cancer meeting the following criteria:

• Newly diagnosed disease

• Locally advanced or operable primary disease > 2 cm, without evidence of metastatic disease

• Clinical T2 (> 2 cm), T3 (> 5 cm), or T4 primary tumors with or without clinical lymph node involvement (N0-3)

• T4 tumors are defined by any of the following:

• Skin ulceration

• Satellite nodules

• Peau d' orange (skin edema)

• Chest wall invasion

• Inflammatory breast cancer

• Her-2/neu 0-1+ by IHC (or negative by fluorescent in situ hybridization if Her-2 2+ by immunohistochemistry)

• No metastatic disease

• Hormone receptor status:

• Estrogen and progesterone receptor-negative disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Female

• Menopausal status not specified

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• Life expectancy > 10 years

• Leukocytes ≥ 3,000/μL

• Absolute neutrophil count ≥ 1,500/μL

• Platelets ≥ 100,000/μL

• Total bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Cardiac ejection fraction ≥ 50% as assessed by MUGA scan or 2D echocardiogram

Exclusion criteria:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or other agents used in the study

• Pre-existing peripheral neuropathy

• Uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situations that would limit compliance with study requirements

• Prior malignancies except for basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No HIV-positive patients receiving combination antiretroviral therapy

• No concurrent primary growth factor prophylaxis

• No other concurrent investigational agents

• No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, surgery for cancer, or experimental medications