Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Study Overview
=================
Brief Summary
-----------------
Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown that hypofractionated radiotherapy had similar toxicities to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Detailed Description
-----------------
Results from a phase III randomized controlled study in China showed that Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare. Literatures report that reconstruction failure is a well-known complication of radiation therapy in breast cancer patients with reconstruction. Results may vary based on RT timing and technique. Some studies have shown that hypofractionated radiotherapy had similar reconstruction failure to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Official Title
-----------------
Phase II Study of Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Radiation: hypofractionated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic diagnosis of stage I-IIIc invasive breast cancer (ductal, lobular, mammary, medullary, or ductal) ≤ T3 or N+ negative surgery margins positive postoperative pathologic axillary lymph nodes after neoadjuvant chemotherapy (ypN+). Undergo mastectomy+expander+RT（hypofractionated radiotherapy）+delayed prosthesis reconstruction Sign the informed consent form Exclusion Criteria: T4, axillary sentinel lymph node biopsy without axillary dissection Recurrent breast cancer or history of prior breast radiation therapy (neck, chest wall, axilla) Uncontrollable co-morbidities, including but not limited to active collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis), persistent or active infection, symptomatic congestive heart failure, unstable angina, mental illness incapacitating participation in this study Pregnancy or breastfeeding History of malignancy other than the following： (At least 5 years of tumor free survival with a very low risk of recurrence, e.g., carcinoma in situ of the cervix and basal cell or squamous cell carcinoma of the skin） requiring bilateral breast/chest wall radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypofractionated radiation therapy<br>receive chest wall and nodal irradiation at a dose of 43.5 Gy in 15 fractions over 3 weeks | Radiation: hypofractionated radiotherapy<br>* Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reconstruction failure | the 1-year rate of implant removal due to serious complications (such as infection, hematoma, seromatas, prosthesis exposure, prosthesis rupture, envelope contracture, severe breast deformity, etc.) | 12 months after the reconstructive surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetic result | Digital photographs will be taken of each patient to facilitate thorough assessment of breast symmetry, cleavage and donor site scarring. Overall satisfaction is scored on a five-point Likert scale (1 = very unhappy, 5 = very happy). | 12 months after the reconstructive surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypofractionated radiotherapy, Two-Stage Expander/Implant Reconstruction, breast cancer