Using ctDNA to guide therapy for early triple negative breast cancer patients
A Phase II, Open-label, Randomized Trial to Compare Anlotinib and Immunotherapy and Capecitabine Versus Investigator's Choice Therapy in High Risk ctDNA Positive, Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 411 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | anlotinib, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangodng) |
| Trial ID | NCT06992336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are stage II-III triple negative breast cancer patients who have not achieved a pathologic complete response after neoadjuvant therapy.
Not a fit: Patients with inflammatory breast cancer, metaplasia breast cancer, or those with occult breast cancer will not benefit from this study.
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 performed: While there have been studies exploring ctDNA in cancer treatment, this specific combination therapy approach is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Guangzhou, Guangodng
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangodng, China (Recruiting)
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.