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OncoMatch/Clinical Trials/NCT07113613

Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy

Is NCT07113613 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT07113613Data as of May 2026

This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Excluded: BRCA1 mutated susceptibility gene

Excluded: BRCA2 mutated susceptibility gene

Disease stage

Required: Stage N3A

Excluded: Stage N3B, N3C

initially diagnosed as cT1-3N0-3a; Excluded: cT4, N3b-c

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: neoadjuvant therapy — neoadjuvant

Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing

Must have received: breast-conserving surgery

Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm

Cannot have received: chest radiotherapy

Had no previous chest radiotherapy

Cannot have received: radiotherapy in the neck, chest or ipsilateral axilla

history of radiotherapy in the neck, chest or ipsilateral axilla

Lab requirements

Blood counts

basically normal peripheral blood count

Kidney function

no significant abnormalities in kidney function

Liver function

no significant abnormalities in liver function

Cardiac function

no significant abnormalities in heart function; basically normal electrocardiogram

Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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