Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer

NCT07657442 | Not Yet Recruiting DMC

• 1 other identifier: NCC25/095-0095
• Study Type: interventional
• Target: 649
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.

Conditions

Early Stage Breast Carcinoma; Breast Cancer

Keywords

breast cancer; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Local recurrence rate

  Ipsilateral breast recurrence rate

  Five years

Secondary Outcomes (2)

• Disease-free survival rate

  Five years

• Radiation-related adverse events

  Five years

Study Arms (2)

Arm 1: High-risk group

ACTIVE COMPARATOR

Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal disease, defined as two or more breast tumor foci. * Tumor size greater than 3 cm. * Lymphovascular invasion. * Invasive carcinoma with an extensive intraductal component. * Estrogen receptor-negative disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present: * Age younger than 40 years. * Histology of invasive lobular carcinoma or micropapillary carcinoma. * Multifocal breast tumor before treatment. * Lymphovascular invasion. * Pathologic stage ypT1-2N0.

Radiation: Whole-breast irradiation and tumor bed boost

Arm 2: Low-risk group

ACTIVE COMPARATOR

Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria: ① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease. ② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease. Patients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0/isN0.

Radiation: Partial-breast irradiation

Interventions

Whole-breast irradiation and tumor bed boost RADIATION

Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions

Arm 1: High-risk group

Partial-breast irradiation RADIATION

Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions

Arm 2: Low-risk group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status score of 0 to 2.
• Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.
• Clinical stage cT0-2N0M0.
• Underwent breast-conserving surgery.
• Negative surgical margins greater than 2 mm.

You may not qualify if:

• Regional lymph node metastasis.
• Distant metastasis.
• Bilateral breast cancer.
• Prior thoracic radiotherapy.
• Life expectancy of less than 5 years.
• Lactating or pregnant women.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shu-Lian Wang, MD

CONTACT

8610-87788803; wangsl@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)