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

Primary Purpose

Breast Cancer, HER2-positive Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib Plus Fulvestrant
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic Breast Cancer, Pyrotinib, Fulvestrant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib plus Fulvestrant

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
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

OS (overall survival)
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)
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.

Full Information

First Posted
July 23, 2019
Last Updated
July 23, 2019
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04033172
Brief Title
Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
Acronym
Pyrotinib
Official Title
Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2-positive Breast Cancer
Keywords
Metastatic Breast Cancer, Pyrotinib, Fulvestrant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pyrotinib plus Fulvestrant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pyrotinib Plus Fulvestrant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Estimated up to 1 year
Secondary Outcome Measure Information:
Title
OS (overall survival)
Description
Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time Frame
Estimated up to 1 year
Title
Objective Response Rate (ORR)
Description
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Time Frame
Estimated up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). ECOG score ≤ 2, expected survival ≥ 3 months. Histology or cytology confirmed as breast cancer. Prior to trastuzumab and endocrine therapy and progression/recurrence. At least one RECIST 1.1 defined measurable lesions. Normal function of major organs. Exclusion Criteria: pregnant or lactating women 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. 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). Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) Patients with central nervous system disorders or mental disorders Bone metastasis lesions only, no other measurable lesions. Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control. Uncontrolled heart disease. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. Uncontrolled rain metastasis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan
Phone
+8613501270834
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Yue
Phone
+8618612621749
Email
sunlight_1985@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jian Yue
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan
Phone
+8613501270834
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jian Yue
Phone
+8618612621749
Email
sunlight_1985@163.com
First Name & Middle Initial & Last Name & Degree
Peng Yuan
First Name & Middle Initial & Last Name & Degree
Jian Yue

12. IPD Sharing Statement

Plan to Share IPD
No

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

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