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

C

Centre Antoine Lacassagne

Status and phase

Completed
Phase 1

Conditions

Breast Cancer

Treatments

Drug: docetaxel
Radiation: hypofractionated radiation therapy
Procedure: neoadjuvant therapy
Drug: fluorouracil
Radiation: radiation therapy
Radiation: image-guided radiation therapy
Radiation: stereotactic radiosurgery
Drug: cyclophosphamide
Procedure: therapeutic conventional surgery
Drug: epirubicin hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00872625
CDR0000633331
EUDRACT-2006-A00250-51
CALACASS-CYBERNEO
INCA-RECF0621
CALACASS-2006/24

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Cyberknife
Experimental group
Treatment:
Drug: epirubicin hydrochloride
Procedure: therapeutic conventional surgery
Drug: cyclophosphamide
Radiation: stereotactic radiosurgery
Radiation: image-guided radiation therapy
Radiation: radiation therapy
Procedure: neoadjuvant therapy
Drug: fluorouracil
Radiation: hypofractionated radiation therapy
Drug: docetaxel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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