Can a Triple-Drug combo keep advanced breast cancer in check?
NCT ID NCT07732491
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This phase II trial is testing whether adding a new oral drug called culmerciclib to standard anti-HER2 therapy and hormone therapy can help maintain control of advanced breast cancer that is both hormone receptor-positive and HER2-positive. The study enrolls women with metastatic or locally advanced breast cancer that cannot be removed surgically. Participants receive culmerciclib at increasing doses along with trastuzumab (with or without pertuzumab) and a doctor-chosen endocrine therapy, continuing until the disease worsens or side effects become unacceptable. The main goal is to see how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- culmerciclib combined with anti-HER2 therapy (trastuzumab with or without pertuzumab) and endocrine therapy
- What this could lead to
- If successful, this combination could offer a new maintenance treatment option to help delay disease progression in people with HR-positive, HER2-positive advanced breast cancer.
- What could go wrong
- This is a small, early-phase trial with no control group, so results may not be definitive. The drug combination may cause side effects, and its benefit over existing treatments is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer. 2. 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%. 3. Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing. 4. 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. 5. 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. 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. Exclusion Criteria: 1. Patients with extensive leptomeningeal metastases that are poorly controlled with corticosteroids or other dehydrating agents, or requiring urgent radiotherapy. 2. Symptomatic active brain metastases requiring urgent cranial radiotherapy. Patients with asymptomatic CNS metastases are allowed. 3. Disease progression after whole-brain radiotherapy or stereotactic radiosurgery to all intracranial lesions. 4. 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. 5. History of grade 3 or 4 allergic reactions related to study drugs. 6. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematologic, endocrine, or neuropsychiatric disorders. 7. 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. 8. Prior anti-tumor therapy with unresolved adverse events/reactions before study initiation. 9. 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. 10. Any severe underlying disease, comorbidity, or active infection. 11. Concurrent receipt of other anti-tumor therapy. 12. History of epilepsy or seizure predisposition. 13. Pregnant or breastfeeding women. 14. Poor compliance or inability to attend scheduled follow-up visits. 15. Known hypersensitivity to the study drugs. 16. 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. 17. Other conditions judged by the investigator that may interfere with the conduct or outcome of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun yat-Sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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