Breast CancerPhase 2NCT07732491
Culmerciclib in HR+/HER2+ Advanced Breast Cancer
A Phase 2 study testing Culmerciclib in people with Breast Cancer and Metastastic Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastastic Breast Cancer, HER2+ Advanced Breast Cancer
- What is being tested?
- Culmerciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2035
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- Hormone receptor-positive and HER2-positive disease. HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by fluorescence in situ hybridization (FISH). If multiple tumor specimens have been tested, the most recent test result shall be used. Hormone receptor positivity is defined as estrogen receptor (ER) expression of at least 10%.
- Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing.
- Patients with brain metastases are eligible if they have asymptomatic central nervous system (CNS) metastases, defined as no CNS symptoms or symptoms are controlled and do not require urgent radiotherapy.
- Prior radiotherapy, chemotherapy, or anti-HER2 targeted therapy received in the neoadjuvant or adjuvant setting is permitted.
- 5、Patients must have achieved a response to first-line systemic anti-tumor therapy for locally recurrent or metastatic disease, with at least 4 cycles of chemotherapy completed and no evidence of radiographic progression.
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- 6、Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. 7、Life expectancy of at least 12 weeks. 8、Adequate major organ function as defined by the following criteria: Hematologic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥85 g/L (without transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).
- Biochemical function: total bilirubin (TBIL) <1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5×ULN (or <5×ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine ≤1×ULN or calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
- 9、Women of childbearing potential must have practiced reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 8 weeks after the last dose of study drug.
- 10、Patients must voluntarily sign informed consent, be willing and able to comply with the study protocol and follow-up visits.
Who cannot join
- Patients with extensive leptomeningeal metastases that are poorly controlled with corticosteroids or other dehydrating agents, or requiring urgent radiotherapy.
- Symptomatic active brain metastases requiring urgent cranial radiotherapy. Patients with asymptomatic CNS metastases are allowed.
- Disease progression after whole-brain radiotherapy or stereotactic radiosurgery to all intracranial lesions.
- Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, unless the condition has been stable for at least 1 month and corticosteroids have been discontinued for >2 weeks.
- History of grade 3 or 4 allergic reactions related to study drugs.
- History of clinically significant cardiovascular, hepatic, respiratory, renal, hematologic, endocrine, or neuropsychiatric disorders.
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- Acute or chronic active hepatitis B (defined as hepatitis B surface antigen and/or hepatitis B core antibody positive with HBV DNA ≥1×10³ copies/mL or ≥200 IU/mL) or acute or chronic active hepatitis C antibody positive; patients with positive hepatitis C antibody but negative RNA test are eligible.
- Prior anti-tumor therapy with unresolved adverse events/reactions before study initiation.
- History or evidence of any condition, therapy, or laboratory abnormality that might interfere with the study results or preclude the patient's full participation, or other conditions deemed unsuitable for enrollment by the investigator.
- Any severe underlying disease, comorbidity, or active infection.
- Concurrent receipt of other anti-tumor therapy.
- History of epilepsy or seizure predisposition.
- Pregnant or breastfeeding women.
- Poor compliance or inability to attend scheduled follow-up visits.
- Known hypersensitivity to the study drugs.
- Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated with curative surgery, or malignancy diagnosed >2 years prior with no evidence of disease and not treated within ≤2 years before randomization.
- Other conditions judged by the investigator that may interfere with the conduct or outcome of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Yanxia Shi, Doctor, 02087341812, shiyx@sysucc.org.cn
Yanxia Shi, Doctor
About this study
Official title: A Phase II, Multicenter, Open-Label, Single-Arm Study of Culmerciclib Combined With Anti-HER2 Targeted Therapy and Endocrine Therapy as Maintenance Treatment in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer
This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.
Culmerciclib is a novel oral cyclin-dependent kinase 2/4/6 (CDK2/4/6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy.
Read more
Patients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up.
The primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.
- Being tested
- Culmerciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CulmerciclibDrug
Culmerciclib in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| TPBC cohort | Experimental | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer Receives: Drug: Culmerciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: rom date of treatment initiation until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first (assessed up to 24 months)
Secondary outcomes (2)
OS
Overall survival
Measured: From date of treatment initiation until death from any cause (assessed up to 36 months)
Safety and tolerability, including incidence and severity of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities graded according to CTCAE v5.0.
Safety and tolerability, including incidence and severity of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities graded according to CTCAE v5.0.
Measured: From date of first dose through 28 days after last dose (assessed up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2035 (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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiting Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732491
- Sponsor's protocol ID
- SYSUCC-Maintenance
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label, Single-Arm Study of Culmerciclib Combined With Anti-HER2 Targeted Therapy and Endocrine Therapy as Maintenance Treatment in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07732491
- Acronym / sponsor ID
- SYSUCC-Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 29 Jul 2026 (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 phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.
Culmerciclib is a novel oral cyclin-dependent kinase 2/4/6 (CDK2/4/6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy.
Patients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up.
The primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPBC cohort | Experimental | Drug: CulmerciclibHormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- Hormone receptor-positive and HER2-positive disease. HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by fluorescence in situ hybridization (FISH). If multiple tumor specimens have been tested, the most recent test result shall be used. Hormone receptor positivity is defined as estrogen receptor (ER) expression of at least 10%.
- Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing.
- Patients with brain metastases are eligible if they have asymptomatic central nervous system (CNS) metastases, defined as no CNS symptoms or symptoms are controlled and do not require urgent radiotherapy.
- Prior radiotherapy, chemotherapy, or anti-HER2 targeted therapy received in the neoadjuvant or adjuvant setting is permitted.
Key exclusion criteria (17 listed)
- Patients with extensive leptomeningeal metastases that are poorly controlled with corticosteroids or other dehydrating agents, or requiring urgent radiotherapy.
- Symptomatic active brain metastases requiring urgent cranial radiotherapy. Patients with asymptomatic CNS metastases are allowed.
- Disease progression after whole-brain radiotherapy or stereotactic radiosurgery to all intracranial lesions.
- Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, unless the condition has been stable for at least 1 month and corticosteroids have been discontinued for >2 weeks.
- History of grade 3 or 4 allergic reactions related to study drugs.
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 |
|---|---|---|
| CulmerciclibCulmerciclib in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy | Drug | TPBC cohort |
Primary outcome
PFS
Time frame: rom date of treatment initiation until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first (assessed up to 24 months)
Progression free survival
2 secondary outcomes
OS
Time frame: From date of treatment initiation until death from any cause (assessed up to 36 months)
Safety and tolerability, including incidence and severity of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities graded according to CTCAE v5.0.
Time frame: From date of first dose through 28 days after last dose (assessed up to 36 months)
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 29 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Culmerciclib in people with Breast Cancer and Metastastic Breast Cancer, run by 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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 29 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Meiting Chen, Doctor (+862087341812, chenmt@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: rom date of treatment initiation until documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first (assessed up to 24 months)). 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 29 Jul 2026.