Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04960839

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

323

Starts

2023-01-01

Expected to finish

2029-12-01

Last updated by the study team

2021-07-14

Who can join

Age: 30 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China
• Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences — Hangzhou, Zhejiang, China
• Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China
• Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University — Hangzhou, Zhejiang, China
• Department of Oncology, Zhejiang Hospital — Hangzhou, Zhejiang, China
• Department of Breast Surgery, Jiangxi Provincial Cancer Hospital — Jiangxi, Jiangxi, China
• Department of Breast Surgery, Yong Loo Lin School of Medicine, National University of Singapore — Singapore, Singapore

Full record on ClinicalTrials.gov

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