Overview

Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib

Status:
Not yet recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
Female
Summary
The hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study. The purpose of this study is: 1. To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR. 2. To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Treatments:
Trastuzumab
Criteria
Inclusion Criteria:

1. Patients with recurrent or distant metastatic breast cancer whose primary tissue was
negative for HER2 amplification, and newly diagnosed patients with stage IV breast
cancer who were negative for HER2 amplification; All enrolled patients had previously
received ≥ second-line therapy; Note: ① negative expression of HER2 refers to the
primary tissue tested by IHC/FISH (clinical report), and the cell immunohistochemical
staining intensity is 0,1 + or 2+, but negative by fluorescence in situ hybridization
(FISH).

2. Age range 18-75, female;

3. Good physical strength: ECOG score 0-1;

4. Expected survival of more than 3 months;

5. The patient had no major organ dysfunction;Include: Routine blood The ANC acuity 1.5 x
109 / L;PLT acuity 90 x 109 / L;Hb 90 g/L or higher; Blood biochemical 1.5 x ULN TBIL
or less;ALT and AST 2 x ULN or less;ALT and AST≤5×ULN in patients with liver
metastases;BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault
formula); Heart colour to exceed LVEF 50% or higher;Fridericia adjusted QT interval
(QTcF) for 12-lead electrocardiogram in men < 450 ms and in women < 470 ms.

6. Evaluable tumor lesions according to RECIST 1.1 criteria;

7. Voluntarily join the group, agree and sign the written informed consent.

Exclusion Criteria:

1. Patients who have previously received anti-HER2 therapy, or who have received a study
drug or preparation/treatment (i.e., participating in another trial) within 4 weeks
prior to enrollment;

2. Patients who are allergic to study drugs or unable to take them orally;Patients who
refuse the medication regimen;

3. Serious dysfunction of vital organs (heart, liver, kidney);Clinically significant
heart disease, i.e., New York Heart Association (NYHA) grade ⅲ - ⅳ heart failure or
more severe congestive heart failure or severe arrhythmias requiring pharmacological
intervention;Uncontrollable angina pectoris, uncontrolled arrhythmia or uncontrolled
hypertension, myocardial infarction within 6 months as confirmed by electrocardiogram
(ECG);Previous history of organ transplantation, splenectomy;

4. Patients with other malignancies, except for cured non-melanoma skin cancers, cervical
carcinoma in situ and other tumors that have been cured for at least 5 years;

5. Pregnant and lactating women (women of childbearing age are subject to pregnancy
tests), fertile women with positive baseline pregnancy tests, or women of childbearing
age who are unwilling to use effective contraception throughout the study period.;

6. In the active period of other acute infectious diseases or chronic infectious
diseases;

7. A history of uncontrolled epilepsy, central nervous system disease or mental disorder;

8. Persons with disabilities of consciousness and other legal capacity or legal capacity
limited;

9. A known history of human immunodeficiency virus;

10. Other conditions that the investigator considers inappropriate for the patient to
participate in the study.