Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anlotinib ,, Benmelstobart, Capecitabine.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Interventions
- Drug Anlotinib ,
Anlotinib 8mg qd PO，357days - Drug Benmelstobart
Benmelstobart 200mg i.v. Q3W - Drug Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Primary outcome measures
- iDFS [Time frame: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.]
Secondary outcome measures (3)
- dDFS [Time frame: from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months]
- OS [Time frame: from randomization to any of the following events: death of any cause，assessed up to 120 months]
- ctDNA clearance [Time frame: From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months]
Eligibility 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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital — Guangzhou
Identifiers
NCT: NCT06992336 · SYSKY-2025-281-01