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NOT YET RECRUITING
NCT07892508
PHASE2

Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

View on ClinicalTrials.gov

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

Interventions

RADIATION

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.

OTHER

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.

DIAGNOSTIC_TEST

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