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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872625
• Other study ID #: CDR0000633331
• Secondary ID: CALACASS-CYBERNE
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2009
• Last updated: February 8, 2015
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• docetaxel

• epirubicin hydrochloride

• fluorouracil

Procedure:
• neoadjuvant therapy

• therapeutic conventional surgery

Radiation:
• hypofractionated radiation therapy

• image-guided radiation therapy

• radiation therapy

• stereotactic radiosurgery

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum-tolerated dose of radiotherapy		6 months	Yes