Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer (NCT05466786) | Clinical Trial Compass
RecruitingNot Applicable
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
China255 participantsStarted 2022-08-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female patients aged 18-70 years with pathologically confirmed HER2-low breast cancer (defined as IHC 2+/ISH- or IHC 1+ per ASCO/CAP guidelines);
. ECOG performance status of 0 or 1;
. Treatment-naïve operable primary breast cancer with completed homologous recombination deficiency (HRD) assessment;
Exclusion criteria
. Recurrent or inoperable locally advanced breast cancer;
. Bilateral breast cancer;
. History of other malignant tumors within the past 5 years;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
Timeframe: At the time of 4 weeks after surgery
Trial details
NCT IDNCT05466786
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University