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NCT Number: NCT06992336

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Anlotinib ,

Drug

Anlotinib 8mg qd PO，357days

Benmelstobart

Drug

Benmelstobart 200mg i.v. Q3W

Capecitabine

Drug

Capecitabine 1000 or 1250 mg/m2 BID day1-14

Primary outcomes

  1. 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.

    invasive disease free survival

Secondary outcomes

  1. 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

    distant disease free survival

  2. OS

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

    overall survival

  3. 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

    the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2031
Study completion
2036
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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