Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009627
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-07-18
Brief Title:
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Phase II Clinical Study of Darsilide Combined With ExemestaneGoserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter prospective open randomized cohort non controlled phase II clinical study to evaluate the effectiveness and safety of Darxil combined with Exemestanegoserelin 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 Exemestanegoserelin 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 treatmentObjective 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 Simons two-stage design The null hypothesis is a true response rate of 02 while the alternative hypothesis is a true response rate of 04 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None