Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective when given together with zoledronic acid in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride together with cyclophosphamide and docetaxel to see how well it works with or without zoledronic acid in treating patients with large resectable or locally advanced breast cancer.

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

Details

• Lead Sponsor: Borstkanker Onderzoek Groep
• Collaborators: Amgen; Dutch Cancer Society; Novartis; Sanofi
• Treatments: Cyclophosphamide; Diphosphonates; Docetaxel; Doxorubicin; Liposomal doxorubicin; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Large resectable or locally advanced disease

• T2 (≥ 2 cm and positive lymph nodes), T2 (≥ 3 cm), ≥ T3, T4, any N, M0 disease

• Measurable disease (breast and/or lymph nodes)

• HER2-negative disease by core biopsy

• No evidence of distant metastases (M1)

• No prior breast cancer

PATIENT CHARACTERISTICS:

• Female

• Menopausal status unspecified

• WHO performance status 0-2

• Not pregnant or nursing

• WBC ≥ 3.0 x 10^9/L

• Neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Bilirubin ≤ 1.5 times upper limit of normal (UNL)

• ALT and/or AST ≤ 2.5 times UNL

• Alkaline phosphatase ≤ 5 times UNL

• Creatinine clearance ≥ 50 mL/min

• Accessible for treatment and follow-up

• No previous malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• No peripheral neuropathy > grade 2 (of any cause)

• No other serious diseases including recent myocardial infarction, clinical signs of cardiac failure, or clinically significant arrhythmias

• No poor dental health

• No known hypersensitivity reaction to any of the components of the treatment

• No medical or psychological condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent

PRIOR CONCURRENT THERAPY:

• No prior breast surgery except for biopsy

• No prior chemotherapy or radiotherapy

• No prior bisphosphonates