Overview

Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

Status:
Not yet recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
Female
Summary
The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henan Cancer Hospital
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Criteria
Inclusion Criteria:

- Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed
histologically.

- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).

- Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line
treatment in the past;

- 18-70 years old;

- ECOG PS 0-1;

- Life expectancy is not less than 12 weeks;

- At least one measurable lesion according to RECIST 1.1;

- ANC ≥ 2.0×10^9/L, PLT ≥ 100×10^9/L, Hb ≥ 90 g/L; TBIL≤1.5ULN; ALT and AST≤3×ULN(ALT
and AST≤5×ULN if liver metastasis); BUN and Cr≤1.5×ULN;

- LVEF ≥ 50% and QTc≤470 ms.

Exclusion Criteria:

- Patients with symptomatic brain metastasis;

- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors
affecting drug use and absorption;

- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or
molecular targeted therapy within 4 weeks before admission; those who received
anti-tumor endocrine therapy after screening period;

- Participated in other drug clinical trials within 4 weeks before admission;

- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have
been used or are being used in the past;

- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell
carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years;

- A history of immunodeficiency, including HIV positive, HCV, or other acquired,
congenital immunodeficiency disorders, or organ transplantation, is known;

- Has suffered from any heart disease;

- Female patients during pregnancy and lactation, fertile women with positive baseline
pregnancy tests or women of childbearing age who are unwilling to take effective
contraceptive measures throughout the trial;

- According to the judgement of the researchers, there are concomitant diseases that
seriously endanger the safety of patients or affect the completion of research
(including, but not limited to, severe hypertension, severe diabetes, active
infections, etc.);

- Moderate infection occurs within 4 weeks before the first administration (e.g.
intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical
criteria), fever(> 38.5 ℃) of unknown origin occurs during the screening period/before
the first administration;

- Researchers believe that patients are not suitable for any other situation in this
study.