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

Completed

• Conditions: Metastatic Breast Cancer; Gene Abnormality; Circulating Tumor DNA
• Interventions: Drug: Case group; Drug: Control group

• Registration Number: NCT05427617
• Lead Sponsor: Hunan Cancer Hospital

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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Case group	Case group includes patients with druggable ctDNA abnormality.
Control group	Control group	Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.

Primary Outcome Measures

Name	Time	Method
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.