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

NCT05427617 | Completed DMC

• 1 other identifier: KYJJ-2020-022
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Breast Cancer; Circulating Tumor DNA; Gene Abnormality

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Control group

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

Drug: Control group

Case group

Case group includes patients with druggable ctDNA abnormality.

Drug: Case group

Interventions

Control group DRUG

Physician chosen treatment

Control group

Case group DRUG

Druggable ctDNA alterations-guided therapy

Also known as: PARP inhibtior, EGFR inhibitor, CDK4/6 inhibitor, AR antagonists, anti-VEGFR, anti-FGFR, Fulvestrant, ADC drugs, PI3K inhibitor, anti-HER2 treatment, HDAC inhibitor

Case group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood lymphocytes (PBL) and plasma

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups; Diagnosis-Related Groups; Fulvestrant; Histone Deacetylase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: December 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share