Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer

NCT05427617 — Completed, 223 participants, Hunan Cancer Hospital

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Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer

Registry	NCT05427617, acronym ACTDNAGLT
Status	Completed
Study type	Observational
Enrollment	223 (Actual)
Sponsor	Hunan Cancer Hospital (Other)
Conditions	Metastatic Breast Cancer, Circulating Tumor DNA, Gene Abnormality
Interventions	Control group, Case group (Drug)
Dates	start 2016-12-01, primary completion 2019-06-30, completion 2021-06-30, first posted 2022-06-22, last updated 2022-06-22

-Summary

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.

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+Detailed description

This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

+Arms and interventions

Arm	Type	Interventions	Description
Control group		Drug: Control group	Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
Case group		Drug: Case group	Case group includes patients with druggable ctDNA abnormality.

Control group (Drug): Physician chosen treatment
Case group (Drug), also known as PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonists, anti-VEGFR, anti-FGFR, Fulvestrant, ADC drugs, PI3K inhibitor, anti-HER2 treatment, HDAC inhibitor: Druggable ctDNA alterations-guided therapy

+Outcome measures

Primary outcomes

Disease Control Rate (DCR) [From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.]: The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.
Progression-Free Survival [From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.]: The survival time between the beginning of treatment to death or the progression.

+Eligibility

Sex: Female, ages: 18 Years to 70 Years

Inclusion Criteria:

* Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
* No available recommendation for the next treatment regimen;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
* An updated, available pathological HR/HER2 status for metastasis;
* According to RECIST 1.1 standard, there should be at least one measurable target lesion;
* The expected survival time is > 3 months;
* Those aged 18-70 years old;
* Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST < 2.5ULN; TBIL < 1.5ULN; Cr < 1.0ULN
* Signing informed consent;
* Those willing to accept polygenic testing.

Exclusion Criteria:

* Patients with multiple primary tumors;
* Those who are unable to obtain blood samples;
* Those with a history of immunodeficiency or organ transplantation;
* Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
* The researchers think it is not suitable to participate in this experiment.