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Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
RAPID-NeoBC is a prospective, multicentre, response-adapted study with a randomized component for adults with operable, nonmetastatic invasive breast cancer receiving guideline-recommended neoadjuvant systemic therapy. After two treatment cycles, participants with stable disease on blinded central imaging review are randomized 1:1 to continue standard care alone or to receive standard care plus response-adapted preoperative radiotherapy. The primary outcome is centrally reviewed pathological complete response in the breast and sampled regional lymph nodes, defined as ypT0/is ypN0. Participants with complete or partial response continue standard care. Participants with disease progression may enter a nonrandomized radiotherapy rescue pathway if protocol criteria are met. Eligible participants are followed after surgery for recurrence, survival, safety, quality of life, function, and other protocol-defined outcomes.
Official title: RAPID-NeoBC Trial: Response-Adapted Preoperative Irradiation and De-escalated Surgery for Neoadjuvant Therapy in Breast Cancer - a Multicentre Prospective and Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-11-01
Completion Date
2035-12-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Response-adapted preoperative radiotherapy
Eligible breast primary tumors smaller than 5 cm receive 24 Gy in 3 fractions when stereotactic constraints are met. Tumors at least 5 cm, or tumors unsuitable for whole-target stereotactic treatment but eligible for spatially fractionated treatment, may receive a peripheral dose of 20 Gy in 5 fractions with intratumoral vertices of 66.7 Gy in 5 fractions. Pathologically confirmed regional nodes are treated according to size, anatomy, dose constraints, and central approval. All plans require prospective central quality-assurance review.
Guideline-recommended neoadjuvant systemic therapy
The treating physician and multidisciplinary team select a curative-intent regimen. The protocol does not assign, provide, or modify systemic therapy. HER2-positive disease includes anti-HER2 therapy, and at least six cycles or the regimen-defined complete course is planned.
Serial contrast-enhanced breast MRI and breast-specific gamma imaging
Paired examinations are performed at baseline, after cycle 2 and before cycle 3, and before surgery. MRI response is assessed centrally using RECIST 1.1 and directs response-adapted routing after cycle 2.
Locations (2)
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, China