Breast CancerNCT05466786
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
An observational study of Breast Cancer and HER2-low Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, HER2-low Breast Cancer
- What is being tested?
- Standard Management
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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;
- 5）Absence of distant metastasis; 6）Availability of adequate tumor tissue and blood samples for biomarker analysis.
Who cannot join
- Recurrent or inoperable locally advanced breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years;
- Incomplete clinical or pathological data.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
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.
- Conditions
- Breast Cancer, HER2-low Breast Cancer
- Being tested
- Standard Management
- Keywords
- Homologous recombination-related, Homologous recombination deficiency
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ManagementOther
Standard Management
| Study group | Role | What they receive |
|---|---|---|
| Experimental ARM | All patients received standard care for postoperative management. Receives: Other: Standard Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
the distribution and features of HRD /HRR is evaluated.
Measured: At the time of 4 weeks after surgery
Secondary outcomes (3)
To assess the clinical characteristics between patients with mutations and non-mutation
Association between mutations and non-mutations group in HRD/HRR is assessed.
Measured: At the time of 4 weeks after surgery
To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression
IDFS, was a composite endpoint defined as the time from enrollment until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.
3-year Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive.
Association between IDFS/OS and HRD/HRR information is evaluated.
Measured: At the time of 36 months after surgery
To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression
Association between multivariate prognostic factors and survival is evaluated.
Measured: At the time of 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start7 Aug 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Gong Chang, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466786
- Sponsor's protocol ID
- SYSKY-2022-030-01
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
- ClinicalTrials.gov ID
- NCT05466786
- Acronym / sponsor ID
- SYSKY-2022-030-01
- Conditions
- Breast Cancer, HER2-low Breast Cancer
- Keywords
- Homologous recombination-related, Homologous recombination deficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 7 Aug 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental ARM | – | Other: Standard ManagementAll patients received standard care for postoperative management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (4 listed)
- 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;
- 5）Absence of distant metastasis; 6）Availability of adequate tumor tissue and blood samples for biomarker analysis.
Key exclusion criteria (4 listed)
- Recurrent or inoperable locally advanced breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years;
- Incomplete clinical or pathological data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ManagementStandard Management | Other | Experimental ARM |
Primary outcome
1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
Time frame: At the time of 4 weeks after surgery
the distribution and features of HRD /HRR is evaluated.
3 secondary outcomes
To assess the clinical characteristics between patients with mutations and non-mutation
Time frame: At the time of 4 weeks after surgery
To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression
Time frame: At the time of 36 months after surgery
To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression
Time frame: At the time of 4 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gong Chang, doctor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2-low Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population (time frame: At the time of 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.