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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: docetaxel
* Drug: epirubicin hydrochloride
* Drug: fluorouracil
* Procedure: neoadjuvant therapy
* Procedure: therapeutic conventional surgery
* Radiation: hypofractionated radiation therapy
* Radiation: image-guided radiation therapy
* Radiation: radiation therapy
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyberknife<br> | Drug: cyclophosphamide<br> <br> Drug: docetaxel<br> <br> Drug: epirubicin hydrochloride<br> <br> Drug: fluorouracil<br> <br> Procedure: neoadjuvant therapy<br> <br> Procedure: therapeutic conventional surgery<br> <br> Radiation: hypofractionated radiation therapy<br> <br> Radiation: image-guided radiation therapy<br> <br> Radiation: radiation therapy<br> <br> Radiation: stereotactic radiosurgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum-tolerated dose of radiotherapy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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