Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer

StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later May 31, 2027 → Dec 31, 2028
See other at-risk trials from Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Record History

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  1. Primary and study completion pushed from May 31, 2027 to Dec 31, 2028 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  2. Start date: Jul 15, 2022 to Aug 7, 2022v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Enrollment target: 335 to 255
    • Eligibility criteria shortened, about 46 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  4. Study First Submitted
  • 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 is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this study to examine the distribution and features of HRD/HRR (homologous recombination repair). In this study, investigators plan to clarify the frequency of HRR/HRD in Chinese patients with HER2-low breast cancer. In addition, it is planned to investigate any association between invasive disease-free survival (iDFS)/overall survival (OS) and HRD/HRR in HER2-low breast cancer patients.
Trial Details
NCT Number NCT05466786
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions
(from sponsor)		 Breast Cancer, HER2-low Breast Cancer
Related terms Breast Neoplasms
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov