Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

Tianjin Medical University

Status: Unknown

Conditions: Breast Cancer

Treatments: Procedure: Immediate Breast reconstruction; Radiation: Radiation; Procedure: Delayed Breast Reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT03743324

E2018210

Details and patient eligibility

About

The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.

Full description

In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management. However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds. It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome. Most studies in this field are retrospective, and studies on Chinese cohort are also rare. This multi-center prospectively designed clinical trial will include several medical centers across China. The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based). Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.

Enrollment: 1,344 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with breast cancer
• Karnofsky Performance Status (KPS) larger than 70
• Underwent autologous or prosthetic based breast reconstruction
• No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

Exclusion criteria

• Metastatic breast cancer
• Local recurrence after mastectomy
• Prior radiation history to chest wall due to other tumors
• Radiation performed more than 6 months after mastectomy
• Interruption of radiation more than 2 weeks
• Gravida or during lactation
• Concurrently undergoing psychotic disorders

Trial design

1,344 participants in 3 patient groups

BR group

Description:

Breast reconstruction without radiation therapy

Treatment:

Procedure: Immediate Breast reconstruction

Procedure: Delayed Breast Reconstruction

Immediate BR +post-op radiation

Description:

Immediate breast reconstruction followed by surgical site radiation therapy

Treatment:

Procedure: Immediate Breast reconstruction

Radiation: Radiation

Radiation +delayed BR

Description:

previous post-mastectomy radiation followed by delayed breast reconstruction

Treatment:

Radiation: Radiation

Procedure: Delayed Breast Reconstruction