A Phase 1 interventional study of cyclophosphamide and docetaxel in Breast Cancer, sponsored by Centre Antoine Lacassagne. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Centre Antoine Lacassagne · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Antoine Lacassagne is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of breast cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
Maximum-tolerated dose of radiotherapy
Time frame: 6 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Centre Antoine Lacassagne