Partial breast irradiation for early-stage breast cancer

Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial

This study is testing if a shorter 2-week radiation treatment for early-stage breast cancer is just as safe and effective as the standard 3-week treatment for women who have had breast-conserving surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 45 Years to 74 Years
• Sex: Female
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06615466 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of a 2-week schedule of partial breast irradiation compared to a 3-week whole-breast radiotherapy regimen for women with early-stage low-risk breast cancer following breast-conserving surgery. It aims to identify the appropriate patient population and optimal dose fractionation model for partial breast irradiation in the Chinese demographic. The study will enroll women aged 45 to 75 years with specific tumor characteristics and will assess outcomes within a defined timeframe post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 45 to 75 years with early-stage low-risk breast cancer who have undergone breast-conserving surgery.

Not a fit: Patients with multiple primary tumors, high-grade invasive ductal carcinoma, or certain other specific breast cancer types may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more efficient and effective radiotherapy option for patients with early-stage breast cancer, potentially reducing treatment time and side effects.

How similar studies have performed: Other studies have shown promising results with partial breast irradiation, but this specific approach in the Chinese population is novel.

Eligibility criteria

Inclusion Criteria:

1. ≥45 years old, \<75 years old women
2. Life expectancy \>5 years
3. Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)
4. Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor

   ≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)
5. Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
6. Single focus (with MRI diagnosis)
7. Vascular tumor thrombus negative
8. ER and/or PR positivity (defined as strong positivity in \>1% of tumor cell nuclei)
9. Negative pathological margin≥2mm
10. Place metal markers on the tumor bed
11. Sign the informed consent form

Exclusion Criteria:

1. Multiple primary tumors
2. Invasive ductal carcinoma grade 3
3. Invasive micropapillary carcinoma
4. Lobular carcinoma in situ
5. Invasive lobular carcinoma
6. Simple nipple paget's disease
7. Oncoplastic surgery
8. Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
9. Previous or simultaneous contralateral breast cancer
10. History of ipsilateral chest wall radiotherapy
11. Have active collagen vascular disease

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Guangyi Sun

Conditions: Breast Cancer, Radiotherapy Side Effect