Skipping breast surgery after complete response to pre-surgery chemo and radiation
Eliminating Breast Surgery for Triple Negative or HR-/HER2+ Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy: A Multicenter, Phase 2 Trial (EBCS)
This trial tests whether people with triple-negative or HER2‑positive early breast cancer who have a complete clinical response to pre-surgery chemotherapy plus radiation can safely skip breast surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06498154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18–70 with ECOG 0–1 and clinical T1–2N0 triple‑negative or HR‑negative, HER2‑positive invasive breast cancer who have adequate cardiac function and organ tests and agree to contraception and follow‑up are the intended candidates.
Not a fit: Patients with hormone receptor‑positive disease, node‑positive tumors, incomplete clinical response after neoadjuvant chemoradiotherapy, poor organ function, or who cannot attend close follow‑up are unlikely to benefit.
Why it matters
Potential benefit: If successful, some patients could avoid breast surgery, reducing surgical risks and improving quality of life while maintaining cancer control.
How similar studies have performed: Nonoperative management after a complete response has been explored in small pilot studies and ongoing trials, but omitting surgery remains largely unproven and requires more data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.