Metastatic Breast CancerNCT02611310
A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)
An observational study of Metastatic Breast Cancer, run by Hoffmann-La Roche at 3 sites in Saudi Arabia.
Trial summary
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. 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
- 15 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- 19 Jan 2017to 12 Nov 2018
- 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 with HER2-positive unresectable LA/mBC
Who may be able to join
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
- Able to comply with the study protocol
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
King Abdullah Medical City-Holy Makkah
Holy Makkah, 21583-Makkah P.O.Box-53356
National Guard King Abdulaziz Medical City; Oncology
Riyadh, 11426
King Fahad Medical City; Gastroentrology
Riyadh, 11525
About this study
Official title: Saudi Arabia - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.
- Conditions
- Metastatic 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 administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with HER2-positive 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)
Measured: Up to 5 years
Secondary outcomes (6)
Number of Participants With Adverse Events
Measured: Up to 5 years
Overall Survival (OS)
Measured: Up to 5 years
Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen
Measured: Up to 5 years
Duration of Response (DoR) Per Anti-Cancer Treatment Regimen
Measured: Up to 5 years
Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)
Measured: Up to 5 years
Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start19 Jan 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Why it stopped: Recruitment Target not met
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
- 15 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
- NCT02611310
- Sponsor's protocol ID
- ML29618
- Status last verified
- Jan 2020
- First submitted
- 19 Nov 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saudi Arabia - 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
- NCT02611310
- Acronym / sponsor ID
- ML29618
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment Target not met
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 20 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 is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with HER2-positive 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 with HER2-positive unresectable LA/mBC
Key inclusion criteria (2 listed)
- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
- Able to comply with the study protocol
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention administered in this study. | Other | Participants with HER2-positive unresectable LA/mBC |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 5 years
6 secondary outcomes
Number of Participants With Adverse Events
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen
Time frame: Up to 5 years
Duration of Response (DoR) Per Anti-Cancer Treatment Regimen
Time frame: Up to 5 years
Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)
Time frame: Up to 5 years
Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Recruitment Target not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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
3 sites 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 Hoffmann-La Roche at 3 sites in Saudi Arabia.
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 2 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: stopped early, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia. 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 was stopped early (reason given: Recruitment Target not met). Results are not available in the source record.
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) (time frame: Up to 5 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 7 Jan 2020.