Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer (NCT00872625) | Clinical Trial Compass
CompletedPhase 1
Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer
France26 participantsStarted 2007-04
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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