NCT06603597

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
224mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress8%
Sep 2024Oct 2044

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2044

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2044

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

20 years

First QC Date

September 16, 2024

Last Update Submit

September 2, 2025

Conditions

HER2 + Breast Cancer

Keywords

breast cancerregistryHER2+HER2 positive

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    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 Outcomes (1)

  • Pathologic complete response rate

    From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment

Study Arms (1)

HER2-positive breast cancer

Patients with stage I-IV HER2-positive breast cancer

Eligibility Criteria

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

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

You may qualify if:

  • Stage I-IV HER2-positive breast cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

KUCC - Indian Creek

Overland Park, Kansas, 66211, United States

ACTIVE NOT RECRUITING

KUCC - Overland Park

Overland Park, Kansas, 66215, United States

ACTIVE NOT RECRUITING

KUCC - Briarcliff

Westwood, Kansas, 66205, United States

ACTIVE NOT RECRUITING

KUCC - Olathe

Westwood, Kansas, 66205, United States

ACTIVE NOT RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

KUCC - Lee's Summit

Lee's Summit, Missouri, 64064, United States

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma, serum, buffy layer; fixed tumor tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Coordinator

CONTACT

913-588-6079PRO-HER2@kumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

September 27, 2024

Primary Completion (Estimated)

October 1, 2044

Study Completion (Estimated)

October 1, 2044

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

US(6)