Metastatic Breast CancerNCT02595762
A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Hoffmann-La Roche at 12 sites in 2 countries.
Trial summary
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Advanced Breast Cancer
- How many people
- 110 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 30 Oct 2016to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.
Who may be able to join
- Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
Who cannot join
- None specified
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Greece11 sites
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, 115 22
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, 115 22
ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, 115 28
251 Air Force General Hospital-Oncology Clinic
Athens, 11525
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
Athens, 145 64
IASO
Athens, 151 23
IASO General Hospital of Athens
Athens, 155 62
Attikon University Hospital; 4th Department of Internal Medicine
Haidari, 124 62
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, 185 47
Theagenio Anticancer Hospital; 3Rd Oncology Clinic
Thessaloniki, 546 39
Papageorgiou General Hospital; Medical Oncology
Thessaloniki, 564 29
About this study
Official title: A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
- 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 |
|---|---|---|
| Participants With HER2-Positive Breast Cancer | Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Measured: Baseline up to approximately 8 years
Progression-Free Survival (PFS)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Secondary outcomes (22)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics
Measured: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Country/Region
Measured: Baseline up to approximately 8 years
Overall Survival (OS)
Measured: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Number of Treatment Regimens Received
Measured: Baseline up to approximately 8 years
Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Duration of Response (DOR)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Measured: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Percentage of Participants by Reasons for Treatment Modification
Measured: Baseline up to approximately 8 years
EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score
Measured: Baseline up to approximately 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Measured: Baseline up to approximately 8 years
Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score
Measured: Baseline up to approximately 8 years
Percentage of Participants With HER2 Retesting
Measured: Baseline up to approximately 8 years
Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Total Healthcare Cost
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Length of Hospitalization
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Indirect Disease Related Cost
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities
Measured: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits
Measured: Baseline up to approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start30 Oct 2016
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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 Hoffmann-La RocheThe 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595762
- Sponsor's protocol ID
- ML28801
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2015
- Last updated
- 19 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02595762
- Acronym / sponsor ID
- ML28801
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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 disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With HER2-Positive Breast Cancer | – | –Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.
Key inclusion criteria (1 listed)
- Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
Key exclusion criteria (1 listed)
- None specified
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
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time frame: Baseline up to approximately 8 years
Progression-Free Survival (PFS)
Time frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
22 secondary outcomes
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Country/Region
Time frame: Baseline up to approximately 8 years
Overall Survival (OS)
Time frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Number of Treatment Regimens Received
Time frame: Baseline up to approximately 8 years
Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)
Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Duration of Response (DOR)
Time frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Percentage of Participants by Reasons for Treatment Modification
Time frame: Baseline up to approximately 8 years
EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score
Time frame: Baseline up to approximately 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Time frame: Baseline up to approximately 8 years
Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score
Time frame: Baseline up to approximately 8 years
Percentage of Participants With HER2 Retesting
Time frame: Baseline up to approximately 8 years
Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Total Healthcare Cost
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Length of Hospitalization
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Indirect Disease Related Cost
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits
Time frame: Baseline up to approximately 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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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.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Locally Advanced Breast Cancer, run by Hoffmann-La Roche at 12 sites in 2 countries.
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: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece, Cyprus. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants Receiving Each Unique Treatment Regimen Overall (time frame: Baseline up to approximately 8 years). The study lists 4 primary outcomes in all. 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 19 Aug 2024.