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

NCT ID: NCT00872625

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyberknife

Group Type: EXPERIMENTAL

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

hypofractionated radiation therapy

Intervention Type: RADIATION

image-guided radiation therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

stereotactic radiosurgery

Intervention Type: RADIATION

Interventions

cyclophosphamide

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

hypofractionated radiation therapy

Intervention Type: RADIATION

image-guided radiation therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

stereotactic radiosurgery

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Yves Bondiau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Other Identifiers

CALACASS-CYBERNEO

Identifier Type: -

Identifier Source: secondary_id

CALACASS-2006/24

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0621

Identifier Type: -

Identifier Source: secondary_id

2006-A00250-51

Identifier Type: OTHER

Identifier Source: secondary_id

2006/24

Identifier Type: -

Identifier Source: org_study_id