New treatment option for Breast Cancer
Official title Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
ClinicalTrials.gov ID: NCT07135661
What this study is testing
- What it's testing
- Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy/5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy/25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment.
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Age ≥ 40 years
- Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
- Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0,negative margins (≥ 2 mm)
- No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the ipsilateral chest or breast
You likely can't join if
- Without pathology diagnosis
- Positive margins or close margins (\< 2mm)
- Lymph nodes or distant metastasis
- Bilateral breast cancer or patients with a history of contralateral breast cancer
- Prior radiation therapy to the ipsilateral chest or breast
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
See the full eligibility criteria
- Age ≥ 40 years
- Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
- Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0,negative margins (≥ 2 mm)
- No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the ipsilateral chest or breast
- ECOG 0 \~ 2 or KPS ≥ 70
- Without pathology diagnosis
- Positive margins or close margins (\< 2mm)
- Lymph nodes or distant metastasis
- Bilateral breast cancer or patients with a history of contralateral breast cancer
- Prior radiation therapy to the ipsilateral chest or breast
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.