A Phase 2 interventional study of Dalpiciclib and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in Early Breast Cancer, Adjuvant Therapy and Hormone Receptor Positive / HER2-negative Breast Cancer, sponsored by Fujian Cancer Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.
The primary endpoint is 3-year invasive disease-free survival (iDFS).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Patients will receive dalpiciclib 125 mg orally once daily on days 1-21 of a 28-day cycle for 2 years, in combination with standard endocrine therapy.
Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) · Drug: Dalpiciclib
Patients will receive dalpiciclib 100 mg orally once daily on days 1-21 of a 28-day cycle for 3 years, in combination with standard endocrine therapy.
Drug: Dalpiciclib · Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.
Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.
Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.
3-years Invasive Disease-Free Survival (iDFS)
Time frame: 36 months from randomization
Distant Disease-Free Survival (DDFS)
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: up to 48 months
Incidence and Severity of Adverse Events
According to Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0)
Time frame: From treatment initiation to 30 days after the last dose, up to approximately 36 months
Patient-Reported Outcomes (PROs)
EORTC QLQ-C30 (version 3.0) Quality of Life Questionnaire. The scores of each domain in the scale need to be converted into a 0 - 100 scale through standardized calculation: Functional domains: Higher scores indicate better functional status. Symptom domains: Higher scores indicate more severe symptoms. Global quality of life: Higher scores indicate a better quality of life.
Time frame: Baseline to end of follow-up (up to 48 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Fujian Cancer Hospital