Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| hypofractionated radiation therapy | Radiation | — | UNRESOLVED |
| image-guided radiation therapy | Radiation | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyberknife
- interventionNames
- 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
Primary outcomes (1)
- measure
- Maximum-tolerated dose of radiotherapy
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBondiau 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