One-week versus three-week partial breast irradiation for early-stage breast cancer

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 non-inferiority, phase 3 study compares a one-week IMRT-based partial breast irradiation regimen (26 Gy in 5 fractions) to a three-week regimen (40 Gy in 15 fractions) in low-risk, post-surgery breast cancer patients. Eligible participants include women aged roughly 18–75 with early-stage disease, appropriate tumor characteristics, and clear surgical margins. The trial aims to determine cosmetic outcomes and local control between the two regimens while maintaining standard systemic therapy as indicated. Primary endpoint focuses on cosmetic non-inferiority, with safety and efficacy as key secondary considerations. Conducted at Fudan University Shanghai Cancer Center, the study reflects a multi-center-like framework led by Fudan University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients with an estimated life expectancy greater than 5 years. Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).
* For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.
* For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.
* Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation.
* ECOG performance status 0 or 1.
* Eligible for systemic therapy, without prior neoadjuvant systemic therapy.
* Able to tolerate radiotherapy procedures and position immobilization.
* No contraindications to radiotherapy.
* Written informed consent provided.

Exclusion Criteria:

* Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).
* Positive axillary, internal mammary, or supraclavicular lymph nodes.
* Presence of distant metastasis.
* Paget's disease of the nipple.
* History of prior ipsilateral or contralateral invasive breast cancer or DCIS.
* Bilateral breast cancer.
* Known germline BRCA1 or BRCA2 mutation.
* Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.
* Active or prior second malignancy (except adequately treated non-melanoma skin cancer).
* Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.
* Pregnant or lactating patients.
* Inability or unwillingness to comply with scheduled follow-up visits.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jinli Ma
• Email: ma-jinli@outlook.com
• Phone: +86-21-64175590

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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.