Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy

NCT06992336 | Recruiting Phase 2 DMC

• 1 other identifier: SYSKY-2025-281-01
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• iDFS

  invasive disease free survival

  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 Outcomes (3)

• dDFS

  from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months

• OS

  from randomization to any of the following events: death of any cause，assessed up to 120 months

• ctDNA clearance

  From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Anlotinib ,; Drug: Benmelstobart; Drug: Capecitabine

B

ACTIVE COMPARATOR

Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years.

Drug: Capecitabine

Interventions

Anlotinib , DRUG

Anlotinib 8mg qd PO，357days

A

Benmelstobart DRUG

Benmelstobart 200mg i.v. Q3W

A

Capecitabine DRUG

Capecitabine 1000 or 1250 mg/m2 BID day1-14

A; B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Gender identity is based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangodng, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

anlotinib; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Phd

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 28, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): April 10, 2031
• Study Completion (Estimated): January 1, 2036
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)