Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
NCT ID: NCT06992336
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
411 participants
INTERVENTIONAL
2025-04-10
2036-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Anlotinib 8mg qd PO，357days Benmelstobart 200mg i.v. Q3W or immunotherapy continued as in the NAC. Capecitabine 1000 或 1250 mg/m2 BID day1-14
Anlotinib ,
Anlotinib 8mg qd PO，357days
Benmelstobart
Benmelstobart 200mg i.v. Q3W
Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
B
Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years.
Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Interventions
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Anlotinib ,
Anlotinib 8mg qd PO，357days
Benmelstobart
Benmelstobart 200mg i.v. Q3W
Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Eligibility Criteria
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Inclusion Criteria
* TNBC patients. TNBC was defined as ER \<= 10%, PR \<=10%, HER 0-1, or HER2 2+ and FISH negative.
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Liu Qiang
Professor, Phd
Locations
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Sun Yat-sen Memorial Hospital
Guangzhou, Guangodng, China
Countries
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Facility Contacts
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Ziqing Feng, Bachelor
Role: backup
Other Identifiers
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SYSKY-2025-281-01
Identifier Type: -
Identifier Source: org_study_id
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