Trials / Recruiting
RecruitingNCT04803539
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capecitabine | capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial) |
| DRUG | capecitabine + camrelizumab + apatinib | Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2028-09-01
- Completion
- 2033-09-01
- First posted
- 2021-03-17
- Last updated
- 2023-02-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04803539. Inclusion in this directory is not an endorsement.