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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: 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

• Registration Number: NCT00872625
• Lead Sponsor: Centre Antoine Lacassagne

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-03-28
• Study First Submitted QC: 2009-03-28
• Study First Posted: 2009-03-31
• Primary Completion: 2009-04
• Study Completion: 2010-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyberknife	hypofractionated radiation therapy	-
Cyberknife	stereotactic radiosurgery	-
Cyberknife	neoadjuvant therapy	-
Cyberknife	therapeutic conventional surgery	-
Cyberknife	radiation therapy	-
Cyberknife	epirubicin hydrochloride	-
Cyberknife	image-guided radiation therapy	-
Cyberknife	cyclophosphamide	-
Cyberknife	docetaxel	-
Cyberknife	fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Maximum-tolerated dose of radiotherapy	6 months

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France