NCT04033172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

July 23, 2019

Last Update Submit

July 23, 2019

Conditions

Breast CancerHER2-positive Breast Cancer

Keywords

Metastatic Breast Cancer, Pyrotinib, Fulvestrant

Outcome Measures

Primary Outcomes (1)

  • 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.

    Estimated up to 1 year

Secondary Outcomes (2)

  • OS (overall survival)

    Estimated up to 1 year

  • Objective Response Rate (ORR)

    Estimated up to 1 year

Study Arms (1)

Pyrotinib plus Fulvestrant

EXPERIMENTAL
Drug: Pyrotinib Plus Fulvestrant

Interventions

Pyrotinib Plus FulvestrantDRUG

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.

Pyrotinib plus Fulvestrant

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinibFulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Peng Yuan

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

  • Jian Yue

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan

CONTACT

+8613501270834yuanpeng01@hotmail.com

Jian Yue

CONTACT

+8618612621749sunlight_1985@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

November 1, 2018

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)