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Compares treatment options for Breast Cancer
Official title Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
ClinicalTrials.gov ID: NCT07084519
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- pT3 or N2-3 disease; or pT1-2N1
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Province, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Province, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.