HER2 + Breast CancerPRO-HER2NCT06603597
HER2-positive Breast Cancer Registry
An observational study of HER2 + Breast Cancer, run by Priyanka Sharma at 6 sites in United States.
Trial summary
The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 + Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Sep 2024to Oct 2044
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I-IV HER2-positive breast cancer.
Who may be able to join
- Stage I-IV HER2-positive breast cancer
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 1 recruiting
- Active, not recruiting
KUCC - Lee's Summit
Lee's Summit, Missouri, 64064
- Active, not recruiting
KUCC - Indian Creek
Overland Park, Kansas, 66211
- Active, not recruiting
KUCC - Overland Park
Overland Park, Kansas, 66215
- Active, not recruiting
KUCC - Briarcliff
Westwood, Kansas, 66205
- Active, not recruiting
KUCC - Olathe
Westwood, Kansas, 66205
- Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, 66205
Study Coordinator, 913-588-6079, PRO-HER2@kumc.edu
About this study
Official title: 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.
- Conditions
- HER2 + Breast Cancer
- Keywords
- breast cancer, registry, HER2+, HER2 positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive breast cancer | Patients with stage I-IV HER2-positive breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
For patients with stage I-III HER2-positive breast cancer, percentage of patients who are alive at 5 years after diagnosis.
Measured: From diagnosis to 5 years after diagnosis
Secondary outcomes (1)
Pathologic complete response rate
Percentage of patients with stage I-III HER2-positive breast cancer who received neoadjuvant systemic therapy and experienced pathologic complete response.
Measured: From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completionOct 2044 (estimated)
- Study completionOct 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 + Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Priyanka Sharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Priyanka Sharma, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603597
- Sponsor's protocol ID
- 160944
- Acronym
- PRO-HER2
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Outcomes for HER2-positive Breast Cancer (PRO-HER2)
- ClinicalTrials.gov ID
- NCT06603597
- Acronym / sponsor ID
- PRO-HER2 / 160944
- Conditions
- HER2 + Breast Cancer
- Keywords
- breast cancer, registry, HER2+, HER2 positive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Priyanka SharmaUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Oct 2044 (estimated)
- Study completion
- Oct 2044 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive breast cancer | – | –Patients with stage I-IV HER2-positive breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-IV HER2-positive breast cancer.
Key inclusion criteria (1 listed)
- Stage I-IV HER2-positive breast cancer
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Pathologic complete response rate
Time frame: From start of neoadjuvant systemic treatment until approximately 8 months after start of neoadjuvant systemic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 + Breast Cancer, run by Priyanka Sharma at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (913-588-6079, PRO-HER2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: From diagnosis to 5 years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.