NCT06341894 Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
| NCT ID | NCT06341894 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,163 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2027-06 |
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 1,163 participants in total. It began in 2023-11-17 with a primary completion date of 2027-06.
⚠ 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
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Eligibility Criteria
Inclusion Criteria: * Patient is ≥ 18 years-old * Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause) * Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%) * Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0 * Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion * From operation to enrollment should not exceed 12 months * Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * metastatic disease (Stage IV) or inflammatory breast cancer * Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. * Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * A history of allergy to the drugs in this study； * Unable or unwilling to swallow tablets * History of gastrointestinal disease with diarrhea as the major symptom.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06341894 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Early 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 NCT06341894 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 NCT06341894 currently recruiting?
Yes, NCT06341894 is actively recruiting participants. Contact the research team at liuxiaoan@126.com for enrollment information.
Where is the NCT06341894 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06341894 clinical trial?
NCT06341894 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 1,163 participants.
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