Dalpicilib-Enhanced vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18-70 years
ECOG score of 0-1
Histologically confirmed unilateral invasive cancer (regardless of pathology type)
No macroscopic or microscopic tumor residue after surgical resection
Disqualifiers
Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS)
Received treatment for advanced disease
Metastasis at any site
Any tumor > T4a (with skin involvement, fixation, inflammatory breast cancer)
Trial design
Design model
Parallel
Treatments tested in this trial
Dalpicilib
DrugDalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years.
endocrine therapy
Drugstandard endocrine therapy
Treatment groups
1,388 Participants
are divided into 2 treatment groupsGroup A: standard endocrine therapyActive comparator 1 intervention
Group B: standard endocrine therapy plus dalpicilibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Invasive Disease Free Survival
Invasive Disease Free Survival
Time frame
From enrollment to 3 years post-treatmentSecondary outcomes
1
3-Year Disease-Free Survival
Time frame
From enrollment to 3 years post-treatment2
Overall Survival
Overall Survival
Time frame
From enrollment to 3 years post-treatment3
safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame
From enrollment to 3 years post-treatment4
Patient reported outcomes
Patient-Reported Outcomes (PROs) Assessed by the EORTC QLQ-C30 Questionnaire. Provide a brief description of what aspects of the patient's health or experience the tool will measure (e.g., quality of life, symptom burden, treatment side effects).
Time frame
From enrollment to 3 years post-treatmentSponsors and contacts
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Source ClinicalTrials.gov