Comparing 1-week versus 2-week radiotherapy for high-risk breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.