HER2-positive Breast Cancer Registry (PRO-HER2)

September 2, 2025 updated by: Priyanka Sharma

Prospective Evaluation of Outcomes for HER2-positive Breast Cancer (PRO-HER2)

The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Active, not recruiting
        • KUCC - Indian Creek
      • Overland Park, Kansas, United States, 66215
        • Active, not recruiting
        • KUCC - Overland Park
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • KUCC - Briarcliff
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • KUCC - Olathe
    • Missouri
      • Lee's Summit, Missouri, United States, 64064
        • Active, not recruiting
        • KUCC - Lee's Summit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with stage I-IV HER2-positive breast cancer.

Description

Inclusion Criteria:

  • Stage I-IV HER2-positive breast cancer

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HER2-positive breast cancer
Patients with stage I-IV HER2-positive breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: From diagnosis to 5 years after diagnosis
For patients with stage I-III HER2-positive breast cancer, percentage of patients who are alive at 5 years after diagnosis.
From diagnosis to 5 years after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response rate
Time Frame: From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment
Percentage of patients with stage I-III HER2-positive breast cancer who received neoadjuvant systemic therapy and experienced pathologic complete response.
From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Priyanka Sharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

October 1, 2044

Study Completion (Estimated)

October 1, 2044

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160944

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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