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NCT06992336RecruitingPhase 2

Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy

A Phase II, Open-Label, Randomized Study Comparing Antiangiogenic Therapy Combined With Immunotherapy and Capecitabine Versus Investigator's Choice in Patients With Circulating Tumor DNA-Positive Stage II-III Triple-Negative Breast Cancer Who With Residual Disease After Neoadjuvant Therapy

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk. This trial aims to explore whether the combination of antiangiogenic therapy, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
430 (estimated)
First submitted
29 Apr 2025
Start date
10 Apr 2025
Primary completion date
10 Apr 2031
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT06992336

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 430
  • From 10 Apr 2025 to the primary completion date, 10 Apr 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \-

Who the study is looking for

  • Stage II-III breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer
  • TNBC patients. TNBC was defined as ER \<= 10%, PR \<=10%, HER 0-1, or HER2 2+ and FISH negative.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen Memorial Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.