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

NCT ID: NCT05427617

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2021-06-30

Brief 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.

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.

Conditions

Metastatic Breast Cancer; Circulating Tumor DNA; Gene Abnormality

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Control group

Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.

Control group

Intervention Type: DRUG

Physician chosen treatment

Case group

Case group includes patients with druggable ctDNA abnormality.

Case group

Intervention Type: DRUG

Druggable ctDNA alterations-guided therapy

Interventions

Control group

Physician chosen treatment

Intervention Type: DRUG

Case group

Druggable ctDNA alterations-guided therapy

Intervention Type: DRUG

Other Intervention Names

PARP inhibtior; EGFR inhibitor; CDK4/6 inhibitor; AR antagonists; anti-VEGFR; anti-FGFR; Fulvestrant; ADC drugs; PI3K inhibitor; anti-HER2 treatment; HDAC inhibitor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KYJJ-2020-022

Identifier Type: -

Identifier Source: org_study_id