Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05770531 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
NotableTrial status: Suspended to RecruitingPrimary completion date: Oct 1, 2027 to Aug 1, 2028 · Enrollment target: 120 to 160 · Start date: Oct 2, 2023 to Aug 4, 2023 · 1 morev6Show 4 more changesShow less
Primary completion date: Oct 1, 2027 to Aug 1, 2028
Enrollment target: 120 to 160
Start date: Oct 2, 2023 to Aug 4, 2023
Site details revised
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Pending calendar changesStudy description expanded, about 24 words · Site details revisedv5Show 2 more changesShow less
MinorStart date changed from estimate of Sep 30, 2023 to Oct 2, 2023v4
NotableTrial status: Not Yet Recruiting to RecruitingSite details revisedv3Show 1 more changeShow less
Site details revised
NotableStart date: Apr 30, 2023 to Sep 30, 2023Primary completion date: May 1, 2027 to Oct 1, 2027 · Completion date: May 1, 2028 to Oct 1, 2028v2Show 2 more changesShow less
Primary completion date: May 1, 2027 to Oct 1, 2027
Completion date: May 1, 2028 to Oct 1, 2028
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.