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

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.

Full Title of Study: “Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: June 30, 2019

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.

Interventions

• Drug: Control group
  • Physician chosen treatment
• Drug: Case group
  • Druggable ctDNA alterations-guided therapy

Arms, Groups and Cohorts

• Control group
  • Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
• Case group
  • Case group includes patients with druggable ctDNA abnormality.

Clinical Trial Outcome Measures

Primary Measures

• Disease Control Rate (DCR)
  • Time Frame: 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
  • 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.
  • The survival time between the beginning of treatment to death or the progression.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Hunan Cancer Hospital
• Provider of Information About this Clinical Study
  • Sponsor