Evaluating dalpiciclib with endocrine therapy for early breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.