drugset / Trial / NCT06009627
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
RandomizedParallel-groupSingle-blindTreatment
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
Timeline
- Start
- 2023-04-11
- Primary completion
- 2025-03-11
- Completion
- 2025-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Dalpiciclib | Small molecule | 125 mg | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Goserelin | Other / unclassified | 3.6 mg | — |