What is hypofractionated radiotherapy studying for breast cancer?

Hypofractionated radiotherapy is being studied to compare its safety and effects with conventional radiotherapy in women with high-risk breast cancer after mastectomy and implant reconstruction. The research aims to understand if shorter radiation schedules can provide effective treatment with fewer complications. This trial is led by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 to 75 years with confirmed invasive breast adenocarcinoma who have undergone total mastectomy and implant reconstruction may be eligible. Participants must have completed chemotherapy if prescribed, have no distant metastasis, and meet health status requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including radiation treatment and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

FEMALE

ID07084519

Study Comparing Hypofractionated and Conventional Radiotherapy After Mastectomy with Implant Reconstruction for Breast Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-06-22

506

Participants Needed

Research Sites

92 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of two different radiotherapy methods in women with high-risk breast cancer who have had a total mastectomy followed by immediate implant-based breast reconstruction. This phase 3 trial compares hypofractionated radiotherapy HFRT with conventional fractionated radiotherapy CFRT to evaluate their impact on reconstruction outcomes and cancer control. The study has two treatment groups one receives HFRT delivering 43.5 Gy in 15 fractions over 3 weeks, and the other receives CFRT delivering 50 Gy in 25 fractions over 5 weeks. Both treatments are given after surgery and chemotherapy as appropriate. The trial monitors participants for reconstruction failure and other implant-related adverse events as primary and secondary outcomes. Participants will undergo regular assessments including physical exams, cosmetic evaluations, and quality of life questionnaires at baseline and multiple time points up to five years. Researchers will monitor implant complications, radiation side effects, disease-free survival, and overall survival. The total duration of participation may extend to several years to capture long-term outcomes and safety.

CONDITIONS

Brief Title

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Who Can Participate

Age: 18Years - 75Years

FEMALE

Eligibility Criteria

You may qualify if you...

Female, aged 18 to 75 years
Karnofsky Performance Status of 60 or higher
Histopathologically confirmed invasive breast adenocarcinoma
Total mastectomy with or without nipple-areolar complex preservation plus axillary dissection or sentinel lymph node biopsy with implant or expander placement and negative margins
Pathologic stage pT3 or N2-3 disease, or pT1-2N1
No distant metastasis
Completed standard neoadjuvant or adjuvant chemotherapy cycles
At least 8 weeks post-chemotherapy or 12 weeks post-surgery if no chemotherapy
Signed informed consent

You will not qualify if you...

Prior radiotherapy to chest wall or lymph node regions
Pregnancy or lactation
T4 stage disease
Autologous breast reconstruction on the irradiated breast
Local, regional, or distant metastasis before radiotherapy
Grade 3 or higher implant-related adverse events irreversible before radiotherapy
Bilateral breast cancer requiring bilateral radiotherapy
Concurrent or secondary malignancy with less than 5 years disease-free interval except certain skin, thyroid, or cervical cancers
Active collagen vascular diseases such as systemic lupus erythematosus or scleroderma
Uncontrolled acute cardiovascular disease, substance abuse, or psychiatric disorders

Research Team

Xuran Zhao, MD

Yirui Zhai, MD

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