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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• All patients were operable estrogen receptor (ER) positive (\>1%), regardless of PR expression level, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 negative interpretation guideline standard. Confirmed by the pathological laboratory that the immunohistochemical (IHC) score is 0 or 1-2+and the in situ hybridization (ISH) test is negative (ISH amplification rate\<2.0);

• Stage II-III initial treatment patients whose tumor staging meets the AJCC 8th edition standards;

• At least one measurable breast and/or axillary disease;

• ECOG 0-1, with an estimated lifespan of at least 12 months;

• The functional level of the main organs must meet the following requirements:

⁃ Blood routine: ANC ≥ 1.5 × ten9/L; PLT ≥ 90 × ten9/L; Hb ≥ 90 g/L;Blood biochemistry: TBIL ≤ 2.5 × ULN; ALT and AST ≤ 2.5 × ULN; BUN and Cr≤ 1.5 × ULN;

• Lead ECG: QT interval (QTcF) corrected by Fridericia method\<470 ms for women;

• Able to accept all puncture biopsies required by the protocol;

• Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up;

• Women with fertility potential must have a negative Pregnancy test (urine or serum) within 7 days after administration,

⁃ And agree to use acceptable birth control methods during the study period to avoid pregnancy.

Locations
Other Locations
China
Jie Ge
RECRUITING
Tianjin
Contact Information
Primary
xuejing 1 liu, 1
lxj8109@126.com
19502151516
Time Frame
Start Date: 2023-04-11
Estimated Completion Date: 2026-09-11
Participants
Target number of participants: 119
Treatments
Experimental: Dalcelli+Goserelin+Exemestane
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group A and received darcelli, Exemestane, and Goserelin
Active_comparator: Docetaxel, epirubicin hydrochloride, Cyclophosphamide
SD patients undergoing 2 cycles of preoperative treatment were randomly assigned to Group B and received TAC chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov