Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )

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StatusRecruiting

Keywords

Abstract

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.

Dates

Last Verified:	06/30/2019
First Submitted:	07/22/2019
Estimated Enrollment Submitted:	07/22/2019
First Posted:	07/24/2019
Last Update Submitted:	07/22/2019
Last Update Posted:	07/24/2019
Actual Study Start Date:	10/31/2018
Estimated Primary Completion Date:	02/28/2021
Estimated Study Completion Date:	08/31/2021

Condition or disease

Breast Cancer

HER2-positive Breast Cancer

Intervention/treatment

Drug: Pyrotinib plus Fulvestrant

Phase

Phase 2

Arm Groups

Arm	Intervention/treatment
Experimental: Pyrotinib plus Fulvestrant	Drug: Pyrotinib plus Fulvestrant Pyrotinib: 400 mg/d, q.d., p.o. A course of treatment need 28 days. Fulvestrant: 500 mg/m2 q.d. i.m. A course of treatment need 28 day. First course needs extra dose of fulvestrant 500 mg/m2 q.d. i.m. on day 15.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	Female
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: 1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). 2. ECOG score ≤ 2, expected survival ≥ 3 months. 3. Histology or cytology confirmed as breast cancer. 4. Prior to trastuzumab and endocrine therapy and progression/recurrence. 5. At least one RECIST 1.1 defined measurable lesions. 6. Normal function of major organs. Exclusion Criteria: 1. pregnant or lactating women 2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy. 3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline). 4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) 5. Patients with central nervous system disorders or mental disorders 6. Bone metastasis lesions only, no other measurable lesions. 7. Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control. 8. Uncontrolled heart disease. 9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. 10. Uncontrolled rain metastasis.

Outcome

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Estimated up to 1 year]

Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

Secondary Outcome Measures

1. OS (overall survival) [Estimated up to 1 year]

Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

2. Objective Response Rate (ORR) [Estimated up to 1 year]

Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.