Evaluating dalpiciclib with endocrine therapy for early breast cancer treatment
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
This study is testing if adding dalpiciclib to hormone therapy can help women with early breast cancer that is hormone receptor-positive and HER2-negative feel better and stay cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1163 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06341894 on ClinicalTrials.gov |
What this trial studies
This phase II multi-center, open-label trial aims to assess the efficacy and safety of dalpiciclib combined with endocrine therapy as an adjuvant treatment for patients with medium to high-risk hormone receptor-positive, HER2-negative early breast cancer. The study will include female patients aged 18 and older with histologically confirmed early breast cancer stages IIA to IIIC. Participants may have received prior neoadjuvant or adjuvant chemotherapy or radiotherapy, provided they meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal or premenopausal women with HR+/HER2- early breast cancer who meet the specified staging and performance status criteria.
Not a fit: Patients with metastatic disease or inflammatory breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with early breast cancer by providing a more effective adjuvant therapy option.
How similar studies have performed: Other studies have explored similar combinations of targeted therapies and endocrine treatments, showing promising results, but this specific combination is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaoan Liu, Professor
- Email: liuxiaoan@126.com
- Phone: 025-68308162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.