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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer; Circulating Tumor DNA; Gene Abnormality
• Intervention / Treatment: Drug: Control group; Drug: Case group

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 Type: Observational
• Enrollment (Actual): 223

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.	Drug: Control group; Physician chosen treatment
Case group; Case group includes patients with druggable ctDNA abnormality.	Drug: Case group; Druggable ctDNA alterations-guided therapy; Other Names: PI3K inhibitor; PARP inhibtior; EGFR inhibitor; CDK4/6 inhibitor; AR antagonists; anti-VEGFR; anti-FGFR; Fulvestrant; ADC drugs; anti-HER2 treatment; HDAC inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR)	The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.	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.	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.

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Histone Deacetylase Inhibitors
• Other Study ID Numbers: KYJJ-2020-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No