HR-positive, HER2-negative premenopausal breast cancer
Conditions
Interventions
endocrine therapy group:Dalsilide combined with exemestane
chemotherapy group:TAC
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Premenopausal female patients aged =18 years; 2. All patients had operable estrogen receptor (ER)-positive (>1%), regardless of PR expression level, HER2-receptor-negative invasive breast cancer. Follow the 2018 version of ASCO-CAP HER2 negative interpretation guideline standards. The immunohistochemistry (IHC) score confirmed by the pathology laboratory is 0, or 1-2+ V3.0 2024-01-26 6 / 61 Evaluation of dalcilib combined with exemestane + goserelin neoadjuvant endocrine therapy in HR A multicenter, prospective, open-label, randomized cohort uncontrolled phase II clinical study of efficacy and safety in patients with HER2-positive, HER2-negative premenopausal breast cancer and negative in situ hybridization (ISH) testing (ISH amplification rate =1.5×10^9/L; PLT >=90×10^9/L; Hb >=90 g/L; Blood biochemistry: TBIL<=2.5×ULN; ALT and AST<=2.5 ×ULN; BUN and Cr <= 1.5×ULN; 7. Lead ECG: Fridericia corrected QT interval (QTcF) in women < 470 ms; 8. Ability to undergo all needle biopsies required by the protocol; 9. Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up visits; 10. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of dosing and agree to use an acceptable method of birth control to avoid pregnancy during the study;
Exclusion criteria
Exclusion criteria: 1.Have received any form of anti-neoplastic treatment within 28 days prior to study entry; 2.Concomitantly receiving any anti-tumor treatment other than those specified in the regimen; 3.Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4.stage IV breast cancer; 5.People with severe heart, liver, kidney and other important organ dysfunction; 6.Inability to swallow, chronic diarrhea, and intestinal obstruction, multiple factors that affect drug administration and absorption; 7.Participated in other drug clinical trials within 4 weeks before enrollment; 8.Those with a known history of allergy to the drug components of this regimen; those with a history of immunodeficiency, including positive HIV testing, HCV, active hepatitis B virus, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9.Have ever suffered from any heart disease, including: (1) Arrhythmia requiring drug treatment or clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Anyone judged by the investigator to be unfit to participate in this trial of other heart diseases, etc. 10.Pregnant and lactating female patients, female patients with childbearing potential and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period; 11.According to the researcher's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); 12.A clear history of neurological or psychiatric disorders, including epilepsy or dementia. Any other situation in which the investigator believes the patient is not suitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| residual cancer burden,RCB;AE; | — |
Countries
China
Contacts
Public ContactWang Xin
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed