Metastatic Breast CancerNCT07342309
Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States
An observational study of Metastatic Breast Cancer, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
This study aims to address the following key objectives in patients with HER2-altered mBC: Primary objectives Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 7,933 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 30 Oct 2026
- 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: Adult patients (>=18 years) with confirmed diagnosis of recurrent or de novo metastatic breast cancer (mBC) who were diagnosed between January 1, 2018, through March 31, 2024 (1 year prior to the data cutoff date, March 31, 2025) in the Flatiron Solid Tumor Discovery Clinico-Genomic Database (CGDB).
Who may be able to join
- Overall metastatic breast cancer (mBC) cohort (total population):
- Histologically or cytologically confirmed diagnosis of breast cancer (BC)
- Patient has at least 2 documented clinical visits in the Flatiron network, on different days, during the study period from 1 January 2011 through 31 March 2025
- Initial diagnosis of de novo or recurrent mBC established during the case selection window from 1 January 2018 through 31 March 2024 (1 year prior to the data cutoff date, 31 March 2025)
- -- The date of initial mBC diagnosis will define the study index date
- Aged ≥ 18 years at the study index date
Show all 15Show fewer
- Human epidermal growth factor receptor 2 (HER2)-positive subcohort (mBC HER2+):
- Patients meeting eligibility for the mBC cohort
- Patients can be HER2-mutant or HER2 nonmutant
- Evidence of HER2+ as defined by immunohistochemistry (IHC)/in situ hybridization (ISH) based on a test performed within 180 days before or 180 days after the index date. If a patient does not have any IHC/ISH test during the 180-day periods before or after the index date, then tests performed at any time in the pre-index date period will be examined and any evidence of HER2+ status will classify the patient as HER2+.
- IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH or ISH+ (without further information on IHC) according to American Society of Clinical Oncology/College of American Pathologists guidelines.
- The sample date will be used to define biomarker status. If the sample date is missing, the report date will be used.
- HER2-mutant subcohort (mBC HER2-mutant):
- Patients meeting eligibility for the mBC cohort
- HER2-mutant: Patients are classified as having an HER2 mutation if there is evidence of NGS short variant alterations at any time in the database, regardless of the functional type, which includes missense, nonsense, frameshift, nonframeshift, or splice variants.
Who cannot join
- mBC cohort (total population):
- -To ensure adequate treatment and outcome data, any patient without a visit or medication record (i.e., medication order/administration or LOT) within 90 days of mBC diagnosis (i.e., the time window from 90 days before to 90 days after the mBC diagnosis).
- HER2+ subcohort (mBC HER2+):
- None (other than those applicable for the mBC cohort).
- HER2-mutant subcohort (mBC HER2-mutant):
- Patients who are included in the HER2+ subcohort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Treatment Patterns and Outcomes of Patients With HER2-Altered Metastatic Breast Cancer in the United States
This study aims to address the following key objectives in patients with HER2-altered mBC:
Primary objectives
Read more
- Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with metastatic breast cancer (mBC)
- Among mBC patients with HER2+ and HER2 mutation, describe the following:
- Baseline demographic and clinical characteristics
- Treatment patterns during follow-up including 1L through fifth-line (5L) settings
- Real-world overall survival (rwOS) for 1L through 5L
Secondary objectives
- Among mBC patients with HER2+ and HER2 mutation, examine the following (as permissible in the study data):
- Real-world progression-free survival (rwPFS)
- Real-world time to discontinuation (rwTTD)
- Real-world time to next treatment (rwTTNT)
- Real-world overall response rate (rwORR)
- Conditions
- Metastatic Breast Cancer
- 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 |
|---|---|---|
| Metastatic breast cancer cohort (mBC) | Adult patients (>=18 years) with confirmed diagnosis of recurrent or de novo metastatic breast cancer (mBC) who were diagnosed between January 1, 2018, through March 31, 2024 (1 year prior to the data cutoff date, March 31, 2025) in the Flatiron Solid Tumor Discovery Clinico-Genomic Database (CGDB). | |
| HER2-positive subcohort (mBC HER2+) | Patients meeting eligibility of the mBC cohort. Evidence of HER2 positive (HER2+) as defined by immunohistochemistry (IHC)/in situ hybridization (ISH) * IHC 3+ or * IHC 2+ and evidence of HER2 amplification by ISH or * ISH+ without further information on IHC. | |
| HER2-mutant subcohort (mBC HER2-mutant) | Patients meeting eligibility of the mBC cohort. Evidence of NGS short variant alterations at any time in the database, regardless of the functional type, which includes missense, nonsense, frameshift, nonframeshift, or splice variants. Patients who are not included in the HER2+ subcohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world overall survival (rwOS)
OS as an event for each patient will be defined as the date of death minus the index date + 1. For patients with no record of death, OS will be censored at the last visit date, defined as the date of the last visit of any type prior to data cutoff.
Month and year of death are noted in the Flatiron Discovery Clinico-Genomic Database (CGDB); the day of death will be imputed as the midpoint (15 th) of the month of death.
Endpoint will be assessed separately from the study index date (mBC diagnosis) and each of the line of therapy (LOT) index dates.
Measured: Up to 15 years
Secondary outcomes (4)
Real-world time to treatment discontinuation (rwTTD)
rwTTD is defined as the time from the LOT start date to the end of the LOT + 1 (inclusive of maintenance therapies associated with the main therapeutic regimen).
End of LOT will be defined as a composite of discontinuation (with or without subsequent LOT) or death.
Patients on treatment at the end of the study period will be censored at that date.
Measured: Up to 15 years
Real-world time to next treatment (rwTTNT)
rwTTNT is defined as the difference between subsequent LOT index dates (e.g., time from the 1L start date to the 2L start date, time from 2L start date to the 3L start date).
Patients not receiving a subsequent treatment line will be censored at the last visit date.
Measured: Up to 15 years
Real-world overall response rate (rwORR)
rwORR will be computed as the proportion of patients who achieved either a complete response or a partial response at any time during the therapy line. Distribution of best responses will be reported only for patients with known clinical responses (excluding unknown and missing/not available) for each treatment line.
Endpoint will be assessed separately for each LOT.
Measured: Up to 15 years
Real-world progression-free survival (rwPFS)
rwPFS will be defined as the difference between the index date and first record of disease progression or death after the index date + 1.
For patients with no record of disease progression, rwPFS will be censored at the start of a subsequent LOT or the date of the last clinical note before the end of the study period, whichever is earlier.
Endpoint will be assessed separately from each of the LOT index dates.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Sep 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 7,933 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342309
- Sponsor's protocol ID
- 1479-0045
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore, limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Outcomes of Patients With HER2-Altered Metastatic Breast Cancer in the United States
- ClinicalTrials.gov ID
- NCT07342309
- Acronym / sponsor ID
- 1479-0045
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,933 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
This study aims to address the following key objectives in patients with HER2-altered mBC:
Primary objectives
- Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with metastatic breast cancer (mBC)
- Among mBC patients with HER2+ and HER2 mutation, describe the following:
- Baseline demographic and clinical characteristics
- Treatment patterns during follow-up including 1L through fifth-line (5L) settings
- Real-world overall survival (rwOS) for 1L through 5L
Secondary objectives
- Among mBC patients with HER2+ and HER2 mutation, examine the following (as permissible in the study data):
- Real-world progression-free survival (rwPFS)
- Real-world time to discontinuation (rwTTD)
- Real-world time to next treatment (rwTTNT)
- Real-world overall response rate (rwORR)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer cohort (mBC) | – | –Adult patients (>=18 years) with confirmed diagnosis of recurrent or de novo metastatic breast cancer (mBC) who were diagnosed between January 1, 2018, through March 31, 2024 (1 year prior to the data cutoff date, March 31, 2025) in the Flatiron Solid Tumor Discovery Clinico-Genomic Database (CGDB). |
| HER2-positive subcohort (mBC HER2+) | – | –Patients meeting eligibility of the mBC cohort. Evidence of HER2 positive (HER2+) as defined by immunohistochemistry (IHC)/in situ hybridization (ISH) * IHC 3+ or * IHC 2+ and evidence of HER2 amplification by ISH or * ISH+ without further information on IHC. |
| HER2-mutant subcohort (mBC HER2-mutant) | – | –Patients meeting eligibility of the mBC cohort. Evidence of NGS short variant alterations at any time in the database, regardless of the functional type, which includes missense, nonsense, frameshift, nonframeshift, or splice variants. Patients who are not included in the HER2+ subcohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>=18 years) with confirmed diagnosis of recurrent or de novo metastatic breast cancer (mBC) who were diagnosed between January 1, 2018, through March 31, 2024 (1 year prior to the data cutoff date, March 31, 2025) in the Flatiron Solid Tumor Discovery Clinico-Genomic Database (CGDB).
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed diagnosis of breast cancer (BC)
- Patient has at least 2 documented clinical visits in the Flatiron network, on different days, during the study period from 1 January 2011 through 31 March 2025
- Initial diagnosis of de novo or recurrent mBC established during the case selection window from 1 January 2018 through 31 March 2024 (1 year prior to the data cutoff date, 31 March 2025)
- -- The date of initial mBC diagnosis will define the study index date
- Aged ≥ 18 years at the study index date
Key exclusion criteria (6 listed)
- -To ensure adequate treatment and outcome data, any patient without a visit or medication record (i.e., medication order/administration or LOT) within 90 days of mBC diagnosis (i.e., the time window from 90 days before to 90 days after the mBC diagnosis).
- None (other than those applicable for the mBC cohort).
- Patients who are included in the HER2+ subcohort.
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
Real-world overall survival (rwOS)
Time frame: Up to 15 years
OS as an event for each patient will be defined as the date of death minus the index date + 1. For patients with no record of death, OS will be censored at the last visit date, defined as the date of the last visit of any type prior to data cutoff. Month and year of death are noted in the Flatiron Discovery Clinico-Genomic Database (CGDB); the day of death will be imputed as the midpoint (15 th) of the month of death. Endpoint will be assessed separately from the study index date (mBC diagnosis) and each of the line of therapy (LOT) index dates.
4 secondary outcomes
Real-world time to treatment discontinuation (rwTTD)
Time frame: Up to 15 years
Real-world time to next treatment (rwTTNT)
Time frame: Up to 15 years
Real-world overall response rate (rwORR)
Time frame: Up to 15 years
Real-world progression-free survival (rwPFS)
Time frame: Up to 15 years
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 14 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore, limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Boehringer Ingelheim at 1 site 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 15 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world overall survival (rwOS) (time frame: Up to 15 years). 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 14 Jul 2026.