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

NCT06498154 | Recruiting Phase 2 DMC

• 1 other identifier: TianJin Medical University....
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 5-year EFS

  5 years event-free survival after neoadjuvant chemoradiotherapy

  60 weeks

Secondary Outcomes (2)

• b-pCR

  18 weeks

• OS

  60 weeks

Study Arms (1)

Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy

EXPERIMENTAL

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.

Radiation: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy

Interventions

Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy RADIATION

Neoadjuvant radiotherapy: whole-breast irradiation ( 50 Gy in 25 fractions) plus a mandatory boost (14 Gy in seven fractions, which began on the day following completion of whole-breast irradiation) TCb (HP) \* : Triple negative patients will receive TCb regimens with or without immunotherapy and HER2 positive patients will receive TCb(HP) regimens.

Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Taizhou Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The First Affiliated Hospital of Hainan Medical University: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Chongqing University Cancer Hospital: collaborator
• Tangshan People's Hospital: collaborator

Study Sites (1)

Tianjin medical university cancer institute and hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• XUCHEN CAO, MD

  TianJin Medical University Cancer Institute and Hospitall

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHENGJUN YANG, MD

CONTACT

8613512891631; yangxinpiaoxue001@163.com

QINGSONG PANG, MD

CONTACT

8618622221203; pangqingsong@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Chemotherapy combined with radiotherapy

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2032
• Last Updated: December 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: March 30, 2027
• Access Criteria: Medical scholars in the world

Locations

CN (1)