Comparing two treatment approaches for breast cancer before surgery
Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset
PHASE1; PHASE2 · University Hospital, Grenoble · NCT02806258
This study is testing if combining a type of targeted radiation with chemotherapy can help women with intermediate and high-risk breast cancer do better before surgery compared to just chemotherapy alone.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 362 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Grenoble (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Créteil and 5 other locations) |
| Trial ID | NCT02806258 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of combining accelerated partial breast irradiation (APBI) with chemotherapy in patients with intermediate and high-risk breast cancer, compared to chemotherapy alone. The study involves administering APBI in a sequential manner alongside chemotherapy to potentially improve patient outcomes such as pathologic complete response (pCR) and breast conservation rates. Patients will receive varying doses of radiation based on specific protocols, and those who undergo breast-conserving surgery will also receive postoperative whole breast irradiation. The goal is to achieve better survival rates without increasing toxicity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed invasive breast carcinoma who desire breast conservation and meet specific tumor staging criteria.
Not a fit: Patients with distant metastases or those who cannot tolerate chemotherapy or radiation treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and better quality of life for breast cancer patients while minimizing treatment-related side effects.
How similar studies have performed: Previous studies have shown promising results with similar combined treatment approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age * Histologically confirmed invasive carcinoma of the breast * Patient who desires breast conservation * Tumor stage T1N1, T2-3 N0-1 * Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors. * Lobular and/or ductal invasive carcinoma * Confirmation by imaging (standard +/- MRI) of unicentric and unilateral disease * Luminal B (defined by hormone receptor positive and grade II-III (if available from core biopsy) and Ki67 ≥ 15% or by genomic analysis) and TNG subtypes * HER2 negative * No distant metastases * No contraindication for PST with anthracycline and/or taxane based regimens * Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator with the aid of written information. Exclusion Criteria: * Patients considered too frail for CT whatever their age. * Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT). * Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size * Multicentricity that would not allow BCS as confirmed by breast imaging * Uni or bilateral inflammatory (T4d) BC * Metastatic disease * Other histology types: ciribriform or tubular or mucinous or epideroid carcinomas * Her2 positive * No signed consent to participate in the study * Previous malignancy (except non melanoma skin cancer, thyroid carcinoma, non-invasive cancers outside the breast and patients with previous cancer in remission since more \> 5 years) * Patients with psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule * Patients unwilling or unable to comply with the protocol (especially necessity to undergo breast surgery despite clinical complete response) * Patients who have received any other investigational drugs within 30 days prior to the screening visit * Pregnancy * Active connective tissue disease involving the skin * Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study .
Where this trial is running
Créteil and 5 other locations
- CHI Créteil — Créteil, France (RECRUITING)
- CHU de Grenoble — Grenoble Cedex 09, France (RECRUITING)
- AP-HP Henri mondor — Paris, France (RECRUITING)
- CHU Avicenne — Paris, France (RECRUITING)
- H. Hartmann Institute of Radiotherapy and Radiosurgery — Paris, France (RECRUITING)
- Tenon hospital — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Isabelle Gabelle Flandin, Dr — CHU Grenoble Alpes
- Study coordinator: Isabelle Gabelle Flandin, Dr
- Email: IGabelleFlandin@chu-grenoble.fr
- Phone: + 33 4.76.76.54.35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation, Intermediate and High-risk Luminal and Triple Negative Breast Cancer