NCT07084519 Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
| NCT ID | NCT07084519 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 506 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2029-03-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 506 participants in total. It began in 2026-03-27 with a primary completion date of 2029-03-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction. Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction. Intervention: HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
Eligibility Criteria
Inclusion Criteria: * Female, aged 18-75 years * Karnofsky Performance Status ≥60 * Histopathologically confirmed invasive breast adenocarcinoma * Total mastectomy \[with or without nipple-areolar complex preservation\] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins * pT3 or N2-3 disease; or pT1-2N1 * No distant metastasis * Completed standard neoadjuvant/adjuvant chemotherapy cycles * ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy * Signed informed consent Exclusion Criteria: * Prior radiotherapy to chest wall or nodal regions * Pregnancy or lactation * T4 stage disease * Autologous breast reconstruction of the irradiated breast * Pre-radiotherapy local/regional/distant metastasis * Grade ≥3 implant-related adverse events irreversible before radiotherapy * Bilateral breast cancer requiring bilateral radiotherapy * Concurrent/secondary malignancy with disease-free interval \<5 years \[except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ\] * Active collagen vascular disease, e.g., SLE, scleroderma * Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07084519 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07084519 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 506 participants.
Is NCT07084519 currently recruiting?
Yes, NCT07084519 is actively recruiting participants. Contact the research team at 923791362@qq.com for enrollment information.
Where is the NCT07084519 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07084519 clinical trial?
NCT07084519 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 506 participants.
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