Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 70 Women only

Using ctDNA to guide therapy for early triple negative breast cancer patients

Official title: 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

Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06992336 · Data updated 2026-11-12

This study is testing a new combination of treatments for early-stage triple negative breast cancer patients who still have cancer after initial therapy to see if it helps them do better.

More Breast Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexWomen only
Enrollment430 (estimated)
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Guangzhou, Guangodng)
StatusRecruiting
StartedApril 10, 2025
Main results expectedApril 10, 2031
Study endsJanuary 1, 2036
Registry record updatedOctober 23, 2026
Trial IDNCT06992336 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are stage II-III triple negative breast cancer patients who have not achieved a pathologic complete response after neoadjuvant therapy.

Probably not a fit

Patients with inflammatory breast cancer, metaplasia breast cancer, or those with occult breast cancer will not benefit from this study.

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

What this trial studies

This trial investigates the effectiveness of combining anlotinib, immunotherapy, and capecitabine for early-stage triple negative breast cancer patients who have residual disease after neoadjuvant therapy. The study focuses on patients identified as having a high risk of relapse through circulating tumor DNA (ctDNA) analysis. By comparing this combination therapy to the investigator's choice of treatment, the trial aims to improve outcomes for this challenging subgroup of patients.

Why it matters

Potential benefit: If successful, this approach could significantly reduce relapse rates and improve survival outcomes for patients with early triple negative breast cancer.

How similar studies have gone: While there have been studies exploring ctDNA in cancer treatment, this specific combination therapy approach is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

\-

Where it's running

  • Sun Yat-sen Memorial Hospital
    Guangzhou, Guangodng, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.