HR+HER2+ advanced breast cancer
Conditions
Interventions
Experimental group:Trastuzumab (Zecerpac) + Pyrotinib maleate + Fulvestrant
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Histopathologically confirmed HR-positive, HER2-positive breast cancer; (1) ER-positive and/or PR-positive is defined as the proportion of tumor cells with positive staining accounted for all tumor cells >= 10% (reviewed and confirmed by researchers in the test center); (2) HER2-positive is defined as a standard immunohistochemical (IHC) test for HER2 (3+), or HER2 (2+) and a positive FISH test (reviewed and confirmed by an investigator at the testing center); 3. Patients who failed adjuvant trastuzumab therapy, or progressed after trastuzumab-based combination chemotherapy (= 80 g/L; ANC >= 1.5 x 10^9/L; PLT >= 75 x 10^9/L; (2) Blood biochemistry: TBIL = 50 mL/min (Calculated by the Cockroft-Gault formula); (3) LVEF >= 50%.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with CDK4/6 inhibitors; 2. Patients previously treated with T-DM1; 3. Pregnant or lactating female patients; 4. Participants suffering from serious concomitant diseases, such as infectious diseases. There are many factors affecting the oral administration and absorption of drugs; 5. The participants who were judged by the investigator to be unsuitable for this study. Demographic data, past medical history and treatment history, ECOG score, objective tumor evaluation, safety, concomitant medication/concomitant therapy, progression/death time, and subsequent antineoplastic therapy were collected. Imaging evaluation was performed according to RECIST 1.1 criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease control rate (DCR);Clinical benefit rate (CBR);Duration of response (DOR);Overall survival (OS);Quality of Life (QOL);security; | — |
Countries
China
Contacts
Public ContactChunfang Hao
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed