NCT00872625

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-04-01
• Completion: 2010-12-01
• First posted: 2009-03-31
• Last updated: 2025-09-30

Locations

1 site across 1 country: France