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

NCT00872625 | Completed Phase 1

• 5 other identifiers: 2006/24CALACASS-CYBERNEOCALACASS-2006/24INCA-RECF06212006-A00250-51
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated dose of radiotherapy

  6 months

Study Arms (1)

Cyberknife

EXPERIMENTAL

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

Interventions

cyclophosphamide DRUG

Cyberknife

docetaxel DRUG

Cyberknife

epirubicin hydrochloride DRUG

Cyberknife

fluorouracil DRUG

Cyberknife

neoadjuvant therapy PROCEDURE

Cyberknife

therapeutic conventional surgery PROCEDURE

Cyberknife

hypofractionated radiation therapy RADIATION

Cyberknife

image-guided radiation therapy RADIATION

Cyberknife

radiation therapy RADIATION

Cyberknife

stereotactic radiosurgery RADIATION

Cyberknife

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Bondiau PY, Courdi A, Bahadoran P, Chamorey E, Queille-Roussel C, Lallement M, Birtwisle-Peyrottes I, Chapellier C, Pacquelet-Cheli S, Ferrero JM. Phase 1 clinical trial of stereotactic body radiation therapy concomitant with neoadjuvant chemotherapy for breast cancer. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1193-9. doi: 10.1016/j.ijrobp.2012.10.034. Epub 2013 Jan 16.

  PMID: 23332384 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Neoadjuvant Therapy; Radiotherapy, Image-Guided; Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre-Yves Bondiau, MD, PhD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2009
• First Posted: March 31, 2009
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)