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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hypofractionated radiation therapy

receive chest wall and nodal irradiation at a dose of 43.5 Gy in 15 fractions over 3 weeks

Group Type EXPERIMENTAL

hypofractionated radiotherapy

Intervention Type RADIATION

Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate

Interventions

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hypofractionated radiotherapy

Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No