Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

NCT04960839 | Recruiting DMC

• 1 other identifier: 2019-228
• Study Type: interventional
• Target: 323
• Locations: 2 countries
• Sites: 8

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.

Conditions

Breast Cancer

Keywords

BRCA1; BRCA2; PALB2; Deleterious mutation; Prophylactic irradiation; Contralateral breast cancer risk

Outcome Measures

Primary Outcomes (1)

• Contralateral breast cancer

  The recurrence rate of contralateral breast cancer

  up to 10 years

Secondary Outcomes (5)

• Overal survival

  up to 10 years

• Ipsilateral loco-regional recurrence

  Every 3-6 months. Follow up will be continued until 10 years after lumpectomy or mastectomy for primary breast cancer.

• Distant metastasis

  up to 10 years

• Short time adverse effects

  3 months since radiation treatment start

• Long time adverse effects

  up to 10 years

Study Arms (2)

Standard group

NO INTERVENTION

Standard loco-regional treatment without prophylactic contralateral breast irradiation

Prophylactic irradiation group

EXPERIMENTAL

Standard loco-regional treatment with prophylactic contralateral breast irradiation

Radiation: Prophylactic contralateral breast irradiation

Interventions

Prophylactic contralateral breast irradiation RADIATION

The whole contralateral breast will be irradiated once daily, 5 days a week, for 5-6 weeks, using 1.8-2 Gy/fx to a total dose of 45-50 Gy.

Prophylactic irradiation group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (8)

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, 310000, China

NOT YET RECRUITING

Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, 310000, 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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peifen Fu, M.D.

  Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Wenjun Chen, M.D.

  Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Kejin Wu, M.D.

  Department of Breast Surgery, Obsterics and Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaowen Ding, M.D.

  Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Zhengkui Sun

  Department of Breast Surgery, Jiangxi Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Mikael Hartman

  Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore

  PRINCIPAL INVESTIGATOR

• Yiding Chen

  Department of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jiaojiao Zhou

  Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kun Zhang

  Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Wenhong Xu

  Departmen of Radiology, The Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Zhibing Wu

  Department of Oncology, Zhejiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiding Chen, M.D.

CONTACT

+86-571-87784527; ydchen@zju.edu.cn

Jiaojiao Zhou

CONTACT

+86-571-87214404; zhoujj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: July 14, 2021
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); CN (7)