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

Metastatic Breast Cancer Clinical Trial

— ACTDNAGLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427617
• Other study ID #: KYJJ-2020-022
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Hunan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Circulating Tumor DNA
• Gene Abnormality
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.