Comparing 1-week versus 2-week radiotherapy for high-risk breast cancer patients
HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.
This study is testing whether a shorter 1-week radiotherapy treatment is just as effective as a 2-week treatment for patients with high-risk breast cancer after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1018 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, radiation |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT04472845 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a 1-week hypofractionated radiotherapy schedule compared to a 2-week schedule in patients with high-risk breast cancer following surgery. The research will assess loco-regional control, acute and late toxicities, quality of life, survival rates, and the incidence of second cancers. By reducing the treatment duration, the study seeks to improve patient convenience and reduce healthcare costs while maintaining treatment efficacy. The approach builds on decades of experience with hypofractionated radiotherapy, which has shown promising results in previous trials.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with invasive breast cancer who have undergone mastectomy or breast-conserving surgery.
Not a fit: Patients with distant metastasis or a history of certain malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce treatment time for breast cancer patients while maintaining effective cancer control.
How similar studies have performed: Previous studies have shown favorable outcomes with hypofractionated radiotherapy, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. Female or male 3. Invasive carcinoma of the breast 4. Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed) 5. Concurrent trastuzumab and hormone therapy is allowed 6. Axillary staging and/or dissection 7. Complete microscopic excision of primary tumour 8. pT3-4pN2-3 M0 disease 9. Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy. 10. Written informed consent 11. Able to comply with follow-up Exclusion Criteria: 1. Supraclavicular node or internal mammary node or distant metastasis 2. Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or(ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 3. Contralateral breast cancer, including DCIS, irrespective of date of diagnosis 4. Breast reconstruction using implants 5. Pregnancy 6. Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
Where this trial is running
Chandigarh
- Budhi Singh Yadav — Chandigarh, India (Recruiting)
Study contacts
- Principal investigator: Budhi S Yadav — Post Graduate Institute of Medical Education and Research, Chandigarh
- Study coordinator: Budhi S Yadav, Md
- Email: drbudhi@gmail.com
- Phone: 9815981176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.