Actively Recruiting
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2021-07-14
323
Participants Needed
8
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 30 to 70 years
- Diagnosed with stage 0 to III breast cancer within the past year
- Underwent lumpectomy or mastectomy with known lymph node status
- Have a harmful germline mutation in BRCA1, BRCA2, or PALB2
- No contraindications for radiation therapy
- Agree to preventive radiation treatment to the opposite breast
- May have received any adjuvant or neoadjuvant chemotherapy with radiation starting at least 2 weeks after chemotherapy ends
- May receive endocrine therapy before, during, or after study entry
- May receive targeted therapy (Trastuzumab) before, during, or after study entry
- Eligible for MRI examination of the opposite breast
- Have refused preventive removal of the opposite breast and ovaries
You will not qualify if you...
- Metastatic breast cancer
- History of other cancers besides breast cancer
- Previous radiation to the breast or chest wall not for breast cancer treatment
- Having breast cancer in both breasts at the same time
- Active connective tissue diseases or pneumonia due to risk of radiation toxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Department of Breast Surgery, Jiangxi Provincial Cancer Hospital
Jiangxi, Jiangxi, China
Not Yet Recruiting
2
Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
3
Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
4
Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
5
Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
6
Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
7
Department of Oncology, Zhejiang Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
8
Department of Breast Surgery, Yong Loo Lin School of Medicine, National University of Singapore
Singapore, Singapore
Not Yet Recruiting
Research Team
Y
Yiding Chen, M.D.
CONTACT
J
Jiaojiao Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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