Skipping breast surgery after complete response to pre-surgery chemo and radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, multicenter prospective study enrolling women with T1–2N0 triple‑negative or HER2‑positive breast cancer who receive combined neoadjuvant chemotherapy and radiotherapy. Patients who achieve a clinical complete response are considered for omission of breast surgery and are followed closely for recurrence and survival outcomes. The primary endpoint is five‑year event‑free survival, and secondary endpoints include breast pathologic complete response rate, overall survival, patient‑reported outcomes, safety, and exploratory molecular biomarkers including circulating tumor DNA. The trial also seeks biomarkers that might predict which patients can safely avoid surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Tianjin medical university cancer institute and hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Xuchen Cao, Md — TianJin Medical University Cancer Institute and Hospitall
• Study coordinator: Zhengjun Yang, Md
• Email: yangxinpiaoxue001@163.com
• Phone: 8613512891631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.