NCT06009627

Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed description

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。Objective: To evaluate the efficacy and safety of darsilide combined with endocrine therapy in SD patients with HR positive and HER2 negative premenopausal breast cancer after 2 cycles of neoadjuvant chemotherapy. It is planned to recruit 119 HR positive and HER2 negative premenopausal breast cancer patients in Group A to conduct the trial with Simon's two-stage design. The null hypothesis is a true response rate of 0.2, while the alternative hypothesis is a true response rate of 0.4. The experiment was conducted in two stages. In the first stage, 13 patients were enrolled. If there are ≤ 3 responses in 13 patients, the study will be stopped Early stopping. Otherwise, continue30 patients were enrolled, with a total sample size of 43. If there are ≥ 13 patients responding, the treatment is effective. Group B was randomly assigned in a 1:1 ratio, with the same number of participants as Group A, resulting in 43 final participants. Calculated based on the proportion of SD patients in 2 cycles of neoadjuvant chemotherapy accounting for 80%, and considering a 10% dropout rate, the final enrollment was made The sample size is 119 cases. The actual samples for molecular testing can be randomly selected based on clinical efficacy, with a statistically significant number.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	dalpiciclib、Exemestane、Gosserine	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
DRUG	Docetaxel for injection、Epirubicin hydrochloride for injection、Cyclophosphamide for injection	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

Timeline

• Start date: 2023-04-11
• Primary completion: 2025-03-11
• Completion: 2025-09-11
• First posted: 2023-08-24
• Last updated: 2026-02-10

Locations

1 site across 1 country: China