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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00872625
First received: March 28, 2009
Last updated: February 8, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Breast Cancer
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Maximum-tolerated dose of radiotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyberknife 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872625

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Pierre-Yves Bondiau, MD, PhD Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00872625     History of Changes
Other Study ID Numbers: CDR0000633331, CALACASS-CYBERNEO, CALACASS-2006/24, INCA-RECF0621, EUDRACT-2006-A00250-51
Study First Received: March 28, 2009
Last Updated: February 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 27, 2015