Status:
RECRUITING
Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
PHASE3
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 11 2026
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06009627
Start Date
April 11 2023
End Date
September 11 2026
Last Update
August 24 2023
Active Locations (1)
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1
Jie Ge
Tianjin, Tianjin Municipality, China, 300000