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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06992336

Enrollment

411

Registered

2025-05-28

Start date

2025-04-10

Completion date

2036-01-01

Last updated

2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGAnlotinib ,

Anlotinib 8mg qd PO，357days

DRUGBenmelstobart

Benmelstobart 200mg i.v. Q3W

DRUGCapecitabine

Capecitabine 1000 or 1250 mg/m2 BID day1-14

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
iDFS	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

Measure	Time frame	Description
dDFS	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
OS	from randomization to any of the following events: death of any cause，assessed up to 120 months	overall survival
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	the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026