Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy

Phase 2

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy

• Registration Number: NCT06498154
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.

Detailed Description

The main purpose: To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. Secondary study objective: To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome.

Primary endpoint: 5-year event-free survival (5-year EFS). Secondary end points: Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), overall survival (OS), patient-reported outcomes (PROs) and safety

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-06
• Last Update Submitted: 2024-07-06
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-07-15
• Primary Completion: 2026-12-30
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Female initial treatment patients aged ≥ 18 years and ≤ 70 years old
• ECOG score 0-1
• Clinical T1-2N0 HER2 positive ( HR negative HER2 IHC score of 3+, or 2+and ISH test positive) or triple negative invasive breast cancer
• Left ventricular ejection fraction (LVEF) ≥ 50%
• 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<470ms
• The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L# PLT≥90 × 109/L# Hb≥90 g/L#Blood biochemistry: TBIL ≤ 2.5 × ULN# ALT and AST ≤ 2.5 × ULN# BUN and Cr ≤ 1.5 × ULN#
• For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment
• Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria

• Inflammatory breast cancer
• Metastatic tumor
• Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol.
• Active infections that require systemic treatment
• Has used any medication in this study within 14 days prior to enrollment
• Major surgery (excluding biopsy) performed within 14 days before enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy	Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy	Patients who meet the criteria for enrollment initially receive four cycles of TCb (HP) \* neoadjuvant chemotherapy, followed by neoadjuvant radiotherapy starting from the fifth cycle of TCb (HP) \* neoadjuvant chemotherapy. After completion of six cycles of neoadjuvant chemotherapy, patients underwent breast magnetic resonance imaging. When a patient meets the MRI criteria suggestive of a complete clinical response (cCR), vacuum assisted core biopsy (VACB) targeting the primary lesion is performed under ultrasound or stereotactic guidance. A minimum of six cores, are obtained using a 7-10 G needle. Biopsy specimens are examined by a pathologist to assess the residual tumor and tumor bed. When no tumor or atypical cells are confirmed in the valid VACB specimen, breast and axillary surgery will be omitted.

Primary Outcome Measures

Name	Time	Method
5-year EFS	60 weeks	5 years event-free survival after neoadjuvant chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
b-pCR	18 weeks	Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0)
OS	60 weeks	overall survival after completing of neoadjuvant chemoradiotherapy

Trial Locations

Locations (1)

Tianjin medical university cancer institute and hospital; 🇨🇳 Tianjin, China