NCT07900516 A Prospective, Phase II, Exploratory Study Protocol of a Chemotherapy Sensitivity-based Culmerciclib Combination Regimen in Neoadjuvant Therapy for HR+/HER2- Breast Cancer.
| NCT ID | NCT07900516 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2026-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Initially diagnosed with stage II-III breast cancer according to the AJCC 8th edition staging system. 2. Premenopausal or perimenopausal patients (who must receive ovarian function suppression \[OFS\], including bilateral oophorectomy or GnRHa \[GnRH agonists\]), or postmenopausal patients. 3. Histopathologically confirmed HR+/HER2- breast cancer: estrogen receptor (ER)-positive (\>10%), regardless of progesterone receptor (PR) expression level; HER2-negative invasive breast carcinoma as per the 2018 ASCO-CAP HER2-negative interpretation guidelines, confirmed by the pathology laboratory as immunohistochemistry (IHC) 0, 1+, or 2+ with negative in situ hybridization (ISH) (HER2/CEP17 ratio \<2.0). 4. Female patients aged 18-75 years (inclusive). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy ≥12 weeks. 7. At least one measurable lesion according to RECIST version 1.1. 8. Adequate organ function as defined by: Hematology: absolute neutrophil count (ANC) \>=1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; hemoglobin (Hb) \>=90 g/L. Blood biochemistry: total bilirubin (TBIL) =\<1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\<3×ULN; blood urea nitrogen (BUN) and creatinine (Cr) =\<1.5×ULN, and creatinine clearance \>=50 mL/min. 9.12-lead electrocardiogram (ECG) with QTc interval ≤480 ms. 10.Willing to voluntarily participate, provide written informed consent, and comply with study visits and follow up. Exclusion Criteria: 1. Prior receipt of any form of anti tumor therapy (including chemotherapy, radiotherapy, molecularly targeted therapy, endocrine therapy, etc.). 2. Concurrent use of other anti tumor drugs. 3. Stage IV breast cancer. 4. Breast cancer not confirmed by histopathology. 5. Other malignancies within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. 6. Severe dysfunction of vital organs such as heart, liver, or kidneys. 7. Inability to swallow, chronic diarrhea, or intestinal obstruction, or any condition that may affect oral drug absorption. 8. Participation in another drug clinical trial within 4 weeks prior to enrollment. 9. History of immunodeficiency, including positive HIV test, positive HCV antibodies, active hepatitis B virus infection (HBsAg positive with detectable HBV DNA), or other acquired/congenital immunodeficiency diseases, or history of organ transplantation. 10. Known hypersensitivity to any component of the study drugs. 11. Any cardiac disease, including: arrhythmia requiring medication or clinically significant; myocardial infarction; heart failure; or any other cardiac condition deemed by the investigator as unsuitable for participation. 12. Pregnant or breastfeeding women, or women of childbearing potential with a positive baseline pregnancy test. 13. Concurrent medical conditions that, in the investigator's judgment, may compromise patient safety or interfere with study completion (including but not limited to severe hypertension not controlled by medication, severe diabetes, active infections, etc.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07900516 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07900516 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07900516 currently recruiting?
Yes, NCT07900516 is actively recruiting participants. Contact the research team at Zhouwenbin@njmu.edu.cn for enrollment information.
Where is the NCT07900516 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07900516 clinical trial?
NCT07900516 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 48 participants.
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