Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
NCT ID: NCT06498154
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-07-25
2032-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
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.
Interventions
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Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
The First Affiliated Hospital of Hainan Medical University
OTHER_GOV
Shandong Cancer Hospital and Institute
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Chongqing University Cancer Hospital
OTHER
Tangshan People's Hospital
OTHER
Taizhou Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Xuchen Cao
MD
Principal Investigators
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XUCHEN CAO, MD
Role: PRINCIPAL_INVESTIGATOR
TianJin Medical University Cancer Institute and Hospitall
Locations
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Tianjin medical university cancer institute and hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Xuchen Cao, MD
Role: primary
Other Identifiers
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TianJin Medical University....
Identifier Type: -
Identifier Source: org_study_id