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

Hunan Cancer Hospital223 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

223

Conditions

Metastatic Breast Cancer Circulating Tumor DNA Gene Abnormality

Interventions

Control groupDRUG

Physician chosen treatment

Case groupDRUG

Druggable ctDNA alterations-guided therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Disease Control Rate (DCR)

The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.

Time frame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.

Progression-Free Survival

The survival time between the beginning of treatment to death or the progression.

Time frame: 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.

Data from ClinicalTrials.gov

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