Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Evaluate the tolerance to concurrent neoadjuvant docetaxel and cyberknife hypofractionated radiotherapy followed by standard treatment in women with breast cancer in order to find the maximum-tolerated dose of radiotherapy. Secondary * Evaluate the efficacy of the combination chemoradiotherapy. * Evaluate breast-conserving surgery. * Evaluate the quality of life. OUTLINE: This is a dose-escalation study of cyberknife hypofractionated radiotherapy. Patients receive neoadjuvant docetaxel IV on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning during the first or second course of neoadjuvant chemotherapy, patients undergo hypofractionated radiotherapy. Patients then receive standard chemotherapy comprising epirubicin hydrochloride IV, cyclophosphamide IV, and fluorouracil IV on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 4-8 weeks after the last course of chemotherapy, and then undergo standard radiotherapy.
Interventions
DRUGcyclophosphamide
DRUGdocetaxel
DRUGepirubicin hydrochloride
DRUGfluorouracil
PROCEDUREneoadjuvant therapy
PROCEDUREtherapeutic conventional surgery
RADIATIONhypofractionated radiation therapy
RADIATIONimage-guided radiation therapy
RADIATIONradiation therapy
RADIATIONstereotactic radiosurgery
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum-tolerated dose of radiotherapy | 6 months |
Countries
France
Outcome results
None listed