NCT04960839 Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
| NCT ID | NCT04960839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 323 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 323 participants in total. It began in 2023-01-01 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high. Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality. Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
Eligibility 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.
Contact & Investigator
Peifen Fu, M.D.
PRINCIPAL INVESTIGATOR
Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT04960839 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04960839 currently recruiting?
Yes, NCT04960839 is actively recruiting participants. Contact the research team at ydchen@zju.edu.cn for enrollment information.
Where is the NCT04960839 trial being conducted?
This trial is being conducted at Jiangxi, China, Shanghai, China, Hangzhou, China, Hangzhou, China and 4 additional locations.
Who is sponsoring the NCT04960839 clinical trial?
NCT04960839 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Peifen Fu, M.D. at Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University. The trial plans to enroll 323 participants.
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