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Tests treatment safety and results for HR+/HER2- Early Breast Cancer
Official title Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07616453
What this study is testing
What is Culmerciclib?
Culmerciclib is an investigational medicine, being studied as a potential treatment for hr+/her2- early breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients aged ≥18 and ≤75 years. Histologically confirmed estrogen receptor (ER)-positive (≥10%) and HER2-negative breast cancer, according to...
- Absolute neutrophil count ≥1.5 × 10⁹/L (without growth factor support within 14 days);
- Platelet count ≥100 × 10⁹/L (without transfusion or supportive therapy within 7 days);
- Hemoglobin ≥100 g/L (without transfusion within 7 days). Adequate hepatic and renal function:
- Total bilirubin ≤1 × upper limit of normal (ULN);
You likely can't join if
- Prior receipt of any anticancer therapy, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
- Concurrent treatment with other anticancer agents. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV breast...
- Severe dysfunction of major organs, including heart, liver, or kidneys. Conditions affecting oral drug administration or absorption, including...
- Participation in another treatment clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any component of the study drugs; history of immunodeficiency, including HIV infection, active hepatitis B or C infection...
- History of significant cardiovascular disease, including but not limited to clinically significant arrhythmias requiring treatment, myocardial...
See the full eligibility criteria
- Female patients aged ≥18 and ≤75 years. Histologically confirmed estrogen receptor (ER)-positive (≥10%) and HER2-negative breast cancer, according to the 2018 ASCO/CAP guidelines. HER2-negative status is defined as...
- Absolute neutrophil count ≥1.5 × 10⁹/L (without growth factor support within 14 days);
- Platelet count ≥100 × 10⁹/L (without transfusion or supportive therapy within 7 days);
- Hemoglobin ≥100 g/L (without transfusion within 7 days). Adequate hepatic and renal function:
- Total bilirubin ≤1 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN in patients with liver metastases);
- Blood urea nitrogen and serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula). Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography. QT...
- Prior receipt of any anticancer therapy, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
- Concurrent treatment with other anticancer agents. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV breast cancer. Breast cancer not confirmed by histopathology. History of other...
- Severe dysfunction of major organs, including heart, liver, or kidneys. Conditions affecting oral drug administration or absorption, including inability to swallow, chronic diarrhea, or intestinal obstruction.
- Participation in another treatment clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any component of the study drugs; history of immunodeficiency, including HIV infection, active hepatitis B or C infection, other acquired or congenital immunodeficiency disorders, or history of...
- History of significant cardiovascular disease, including but not limited to clinically significant arrhythmias requiring treatment, myocardial infarction, heart failure, or any other cardiac condition deemed unsuitable...
- Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline, or unwilling to use effective contraception during the study period.
- Any serious concomitant disease that, in the investigator's judgment, may compromise patient safety or compliance with the study, including but not limited to uncontrolled hypertension, severe diabetes, or active...
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.