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

Centre Antoine Lacassagne

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Radiation: hypofractionated radiation therapy; Procedure: neoadjuvant therapy; Drug: fluorouracil; Radiation: radiation therapy; Radiation: image-guided radiation therapy; Radiation: stereotactic radiosurgery; Drug: cyclophosphamide; Procedure: therapeutic conventional surgery; Drug: epirubicin hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00872625

CDR0000633331

EUDRACT-2006-A00250-51

CALACASS-CYBERNEO

INCA-RECF0621

CALACASS-2006/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Cyberknife

Experimental group

Treatment:

Drug: epirubicin hydrochloride

Procedure: therapeutic conventional surgery

Drug: cyclophosphamide

Radiation: stereotactic radiosurgery

Radiation: image-guided radiation therapy

Radiation: radiation therapy

Procedure: neoadjuvant therapy

Drug: fluorouracil

Radiation: hypofractionated radiation therapy

Drug: docetaxel