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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 430 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangodng) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | April 10, 2031 |
| Study ends | January 1, 2036 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06992336 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.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.