Prophylactic irradiation for breast cancer patients with genetic mutations
Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for Breast Cancer Patients With BRCA1, BRCA2 and PALB2 Deleterious Mutation
This study is testing whether radiation treatment can help women with breast cancer and certain genetic mutations lower their risk of developing cancer in the other breast without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 323 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | Trastuzumab, chemotherapy, radiation |
| Locations | 8 sites (Jiangxi, Jiangxi and 7 other locations) |
| Trial ID | NCT04960839 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of prophylactic irradiation to the contralateral breast in female patients diagnosed with breast cancer who carry deleterious mutations in the BRCA1, BRCA2, or PALB2 genes. The study aims to assess the effectiveness of this approach in reducing the risk of subsequent contralateral breast cancer, particularly for patients who have opted against contralateral mastectomy due to concerns about surgical complications and body image. Eligible participants will undergo irradiation after their initial breast cancer treatment, with careful monitoring of their health and response to the intervention. The trial is designed to provide a less invasive alternative to surgery while still addressing the heightened risk of cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 30-70 with stage 0-III breast cancer and a confirmed deleterious germline mutation in BRCA1, BRCA2, or PALB2.
Not a fit: Patients who have contraindications for irradiation or those who have already undergone contralateral mastectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of contralateral breast cancer in mutation carriers without the need for invasive surgery.
How similar studies have performed: While similar approaches have been explored, this specific method of prophylactic irradiation for mutation carriers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients, aged 30-70yrs, diagnosed with stage 0-III breast cancer (NCCN-Breast Cancer V2.2019), undergoing the lumpectomy or mastectomy no more than 1 year. ALND or SLNB should be carried out and the lymph node status should be known. * Patients with a deleterious germline mutation of BRCA 1/2 or PALB2. * The patients with no contraindictation for irradiation. * The patients consent for prophylactic irradiation to the contralateral breast. * The patient may receive any regimen of adjuvant, neoadjuvant chemotherapy, according to the treating physician. The radiation therapy should start at least 2 weeks after the completion of all the chemotherapy cycles. * The patient may receive endocrine therapy before, during or after study entry. * The patient may receive target therapy (Trastuzumab) before, during or after study entry. * The patient must be eligible for MRI examination of the contralateral breast. * The patient refused prophylactic contralateral mastectomy and oophorectomy. Exclusion Criteria: * Metastatic breast cancer. * Past history of other cancer besides breast cancer * Previous irradiation of the breast or chest wall, but not for breast cancer treatment * Synchronous bilateral breast cancer * Patients with active connective tissue diseases, pneumonia are excluded due to the potential risk of significant radiotherapeutic toxicity.
Where this trial is running
Jiangxi, Jiangxi and 7 other locations
- Department of Breast Surgery, Jiangxi Provincial Cancer Hospital — Jiangxi, Jiangxi, China (Not_yet_recruiting)
- Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Department of Oncology, Zhejiang Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Department of Breast Surgery, Yong Loo Lin School of Medicine, National University of Singapore — Singapore, Singapore (Not_yet_recruiting)
Study contacts
- Principal investigator: Peifen Fu, M.D. — Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University
- Study coordinator: Yiding Chen, M.D.
- Email: ydchen@zju.edu.cn
- Phone: +86-571-87784527
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.