Overview

Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis

Status:
Not yet recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shandong Cancer Hospital and Institute
Treatments:
Albumin-Bound Paclitaxel
Trastuzumab
Criteria
Inclusion Criteria:

- Aged >18 years.

- ECOG performance status ≤2.

- Histologically or cytologic confirmed HER2 positive advanced breast cancer.

- MRI confirmed brain metastases. According to RECIST 1.1, at least one measurable
lesion exists.

- No limit of previous chemotherapy lines.

- Previously have not reveived capecitabine or disease progression of capecitabine after
6 months, or progression of capecitabine adjuvant therapy after one year;

- Life expectancy of more than 3 months.

- Required laboratory values including following parameters: ANC: ≥ 1.5 x
10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x
upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with
liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470
ms for female and < 450 ms for male.

- Signed the informed consent form prior to patient entry.

Exclusion Criteria:

- Patients with brain metastases who have extensive meningeal metastases and are treated
with hormone dehydration.

- Subjects with third space fluid(such as a large amount of pleural effusion and
ascites) that can not be controled by drainage or other methods. (such as pleural
effusion and ascites).

- Received whole brain radiotherapy, chemotherapy, surgery or target therapy within 2
weeks prior to randomization. Received hormone therapy within 1 weeks prior to
randomization, Received the nitrosoureas or mitomycin chemotherapy within 6 weeks
prior to randomization.

- Participated in other clinical trial within 4 weeks prior to randomization.

- Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) (including Lapatinib,
Neratinib and Pyrotinib).

- Second malignancies within 5 years, except for cured carcinoma in-situ of uterine
cervix, skin basal cell carcinomaand squamous-cell carcinoma.

- Receiving any other anti-tumor therapies at time of study screening visit.

- There are no other serious and/or uncontrolled diseases that may affect research
participation, including any of the following: (1) unable to swallow, chronic diarrhea
and intestinal obstruction and factors influencing the usage of oral administration;
(2) has allergies or a known history of hypersensitivity to the drug components of
this program; History of Immunodeficiency, acquired or congenital immunodeficiency
(HIV positive) ,history of organ transplantation; (3) History of any kind of Heart
disease, including 1) Myocardial infarction; 2) Heart failure; 3) Any other heart
disease judged by researcher as not suitable for participating in this study, etc; (4)
Infection.

- All female patients in breastfeeding period or in child-bearing period or with
positive pregnancy test result or refusing to take a reliable method of birth control
during the study.

- Any other situations judged by investigator as not suitable for participating in this
study.