CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
dalpiciclib、Exemestane、Gosserine +1 moredrug
Likely dose
dalpiciclib、Exemestane、Gosserine 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06009627
NCT06009627Phase 3Completed

Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

Tianjin Medical University Cancer Institute and Hospital·interventional·Posted Aug 24, 2023·Updated Feb 10, 2026

In Brief

A Phase 3 clinical trial evaluating dalpiciclib、Exemestane、Gosserine and Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection for Breast Cancer. Completed, enrolled 119 participants across 1 site.

Detailed Summary

A multicenter, prospective, open, randomized cohort, non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestane+goserelin neoadjuvant endocrine therapy in HR positive and HER2 negative premenopausal breast cancer patients. The study object was to evaluate the HR positive and HER2 negative premenopausal breast cancer patients with SD after 2 cycles of neoadjuvant chemotherapy. The main endpoint was the objective response rate (ORR) of treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedAug 24, 2023
Enrollment StartApr 11, 2023
Primary CompletionMar 11, 2025
Study CompletionSep 11, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 2.9 years ago

Interventions

dalpiciclib、Exemestane、Gosserinedrug

dalpiciclib: once a day, 125 mg each time, taken for 3 weeks, stopped for 1 week, 1 for 4 weeks Period. It is recommended to take the medication at approximately the same time every day, delivered in warm water, on an empty stomach, at least before taking the medication Fasting for 1 hour before and after. Exemestane: 25mg, oral, once a day, continuous administration. Gosserine: 3.6mg, subcutaneous injection, once every four weeks, continuous administration

Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injectiondrug

Docetaxel for injection: 75mg/m2, intravenous drip, approximately 30 minutes. Dose reduction and delayed administration are allowed every three weeks, with a maximum of three weeks of delayed administration allowed since the last administration time Calculate, otherwise terminate treatment. 5\. Epirubicin hydrochloride for injection: 75mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction And delayed administration, with a maximum allowable delay of 3 weeks, calculated from the last administration time. Otherwise Stop treatment. 6\. Cyclophosphamide for injection: 500mg/m2, intravenous drip. Once every three weeks, allowing for dose reduction and Delayed administration, allowed up to 3 weeks, calculated from the last administration time, otherwise terminated treat