Overview

Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
Female
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, 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) together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Antoine Lacassagne
Treatments:
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of breast cancer

- Unifocal disease

- Non-metastatic disease

- Not a candidate for breast-conserving surgery

- No superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)

- Undergone MRI of the breast to define the macroscopic tumor volume

- Undergone scanning of the breast to mark the location for radiotherapy

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of
an implantable venous device

- No patient for whom clinical follow up is impossible for psychological, familial,
social, or geographical reasons

- No patients deprived of liberty or under trusteeship

PRIOR CONCURRENT THERAPY:

- No prior ipsilateral breast irradiation