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

Overview

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.

Full Title of Study: “Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Pyrotinib plus Fulvestrant

Clinical Trial Outcome Measures

Primary Measures

  • Progression-Free Survival (PFS)
    • Time Frame: 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 Measures

  • OS (overall survival)
    • Time Frame: 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.
  • Objective Response Rate (ORR)
    • Time Frame: Estimated up to 1 year
    • Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peng Yuan, Professor – Chinese Academy of Medical Sciences
  • Overall Official(s)
    • Peng Yuan, Study Chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Jian Yue, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Peng Yuan, +8613501270834, yuanpeng01@hotmail.com

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