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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05427617
Other study ID # KYJJ-2020-022
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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