Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast CancerNCT02616224
A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
An observational study of Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer, run by Hoffmann-La Roche.
Trial summary
This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2025
- 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: Participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrolment.
Who may be able to join
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time
Who cannot join
- There are no exclusion criteria for entry into this study.
About this study
This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Being tested
- No intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention was administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with unresectable LA/mBC | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen
Measured: Up to approximately 8 years
Secondary outcomes (3)
Overall Survival (OS)
Measured: Up to approximately 8 years
Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen
Measured: Up to approximately 8 years
Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy
Measured: 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 posted26 Nov 2015 (estimated)
- Study startSep 2016 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Resource constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT02616224
- Sponsor's protocol ID
- ML29019
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02616224
- Acronym / sponsor ID
- ML29019
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resource constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 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 observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with unresectable LA/mBC | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrolment.
Key inclusion criteria (1 listed)
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time
Key exclusion criteria (1 listed)
- There are no exclusion criteria for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention was administered in this study. | Other | Participants with unresectable LA/mBC |
Primary outcome
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen
Time frame: Up to approximately 8 years
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 8 years
Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen
Time frame: Up to approximately 8 years
Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy
Time frame: Up to approximately 8 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer, run by Hoffmann-La Roche.
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: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen (time frame: Up to approximately 8 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 23 Feb 2017.