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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: cyclophosphamide; Drug: docetaxel; Drug: fluorouracil; Radiation: radiation therapy; Procedure: therapeutic conventional surgery; Procedure: neoadjuvant therapy; Drug: epirubicin hydrochloride; Radiation: stereotactic radiosurgery; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Nice, France, 06189
    • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyberknife	Drug: cyclophosphamide; Drug: docetaxel; Drug: fluorouracil; Radiation: radiation therapy; Procedure: therapeutic conventional surgery; Procedure: neoadjuvant therapy; Drug: epirubicin hydrochloride; Radiation: stereotactic radiosurgery; Radiation: hypofractionated radiation therapy; Radiation: image-guided radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum-tolerated dose of radiotherapy	6 months

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 28, 2009
• First Submitted That Met QC Criteria: March 28, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 8, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage IA breast cancer; stage IB breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Fluorouracil; Epirubicin
• Other Study ID Numbers: CDR0000633331; CALACASS-CYBERNEO; CALACASS-2006/24; INCA-RECF0621; EUDRACT-2006-A00250-51