NCT03908749

Brief Summary

To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

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

First Submitted

Initial submission to the registry

April 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 7, 2019

Last Update Submit

April 7, 2019

Conditions

HER2 Positive Breast Carcinoma

Keywords

Pyrotinib Maleate TabletsHER-2Real word studyEfficacySafety

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

    1 year

  • pCR

    Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual

    1 year

Secondary Outcomes (6)

  • OS

    1 year

  • AE

    1 year

  • ORR

    1 year

  • DCR

    1 year

  • DFS

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with locally advanced her-2 positive breast cancer who are not treated with standard neoadjuvant regimens or who are not treated with standard neoadjuvant regimens.

You may qualify if:

  • Male or female patients .
  • Confirmed by pathological examination of breast cancer patients with positive her-2 expression
  • The researchers determined that the standard neoadjuvant regimen was ineffective in the treatment of patients with locally advanced her-2 positive breast cancer or that the standard neoadjuvant regimen was not applicable.
  • Patients should be voluntary to the trial and provide with signed informed consent
  • The researchers believe patients can benefit from the study.

You may not qualify if:

  • Patients with a known history of allergic reactions and/or hypersensitivity attributed to Pyrotinib maleate tablets or its accessories
  • Pregnant or lactating women
  • Patients with Pyrotinib maleate tablets contraindications
  • Patients of doctors considered unsuitable for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Pan Yueyin

CONTACT

13805695536yueyinpan1965@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 9, 2019

Study Start

April 10, 2019

Primary Completion

April 10, 2020

Study Completion

October 10, 2020

Last Updated

April 9, 2019

Record last verified: 2019-04