Breast Cancer Clinical Trial
Official title:
Phase II Clinical Study of Darsilide Combined With Exemestane+Goserelin Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
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
Status | Recruiting |
Enrollment | 119 |
Est. completion date | September 11, 2026 |
Est. primary completion date | March 11, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Received any form of anti-tumor treatment within 28 days prior to the start of the study; - Simultaneously receiving any anti-tumor treatment beyond the provisions of other protocols; - Bilateral breast cancer, inflammatory breast cancer or occult breast; - Stage IV breast cancer; - Severe dysfunction of important organs such as heart, liver, and kidney; - Unable to swallow, chronic diarrhea and Bowel obstruction, there are many factors that affect drug taking and absorption; - Participated in other drug clinical trials within 4 weeks prior to enrollment; - Those with a known history of allergies to the drug components of this protocol; Have a history of immunodeficiency, including positive Diagnosis of HIV/AIDS test Sex, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases Illness or a history of organ transplantation; - Have ever suffered from any heart disease, including: (1) arrhythmia that requires medication or has clinical significance |
Country | Name | City | State |
---|---|---|---|
China | Jie Ge | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Breast retention rate | Postoperative breast preservation ratio | At the end of the 6 cycle (each cycle is 21 or 28 days) | |
Other | Event free lifetime | The time from the start of randomized clinical trials to the progression of tumors (in any aspect) or death from any cause | At the end of the 6 cycle (each cycle is 21 or 28 days) | |
Other | Overall survival (OS) | Time from randomization to death from any cause | 2years | |
Primary | Objective response rate (ORR) for treatment | The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement | At the end of the second cycle (each cycle is 21 or 28 days) | |
Secondary | Tumor residual load | The number of cancer cells, tumor size, or total number of cancer lesions in the human body after surgery | At the end of the 6 cycle (each cycle is 21 or 28 days) |
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