Breast CancerNCT02954471
Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia
An observational study of Breast Cancer, run by Hoffmann-La Roche at 3 sites in Saudi Arabia.
Trial summary
This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 351 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- 21 Oct 2016to 17 Sep 2019
- 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 Early/Metastatic Breast Cancer in Saudi Arabia
Who may be able to join
- Initially diagnosed with breast cancer
- Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method
- Alive or not alive
Who cannot join
- Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
King Fahad Specialist Hospital; Oncology
Dammam, 31444
King Faisal Specialist Hospital & Research Centre
Jeddah, 21499
National Guard King Abdulaziz Medical City; Oncology
Riyadh, 11426
About this study
Official title: A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia
This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.
- Conditions
- 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 |
|---|---|---|
| Participants With Breast Cancer | This study will retrospectively collect data from participants with breast cancer in Saudi Arabia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Positive HER2 Test Result
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Secondary outcomes (9)
Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Kaplan-Meier Estimate of Overall Survival (OS)
Measured: From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Complete Response as Assessed Using RECIST
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Partial Response as Assessed Using RECIST
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Progressive Disease as Assessed Using RECIST
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants with Stable Disease as Assessed Using RECIST
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Adverse Events
Measured: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start21 Oct 2016
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 351 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
- NCT02954471
- Sponsor's protocol ID
- ML29903
- Status last verified
- Sep 2019
- First submitted
- 2 Nov 2016
- Last updated
- 20 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia
- ClinicalTrials.gov ID
- NCT02954471
- Acronym / sponsor ID
- ML29903
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 3 Nov 2016 (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 retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Breast Cancer | – | –This study will retrospectively collect data from participants with breast cancer in Saudi Arabia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants With Early/Metastatic Breast Cancer in Saudi Arabia
Key inclusion criteria (3 listed)
- Initially diagnosed with breast cancer
- Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method
- Alive or not alive
Key exclusion criteria (1 listed)
- Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
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 With Positive HER2 Test Result
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
9 secondary outcomes
Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Kaplan-Meier Estimate of Overall Survival (OS)
Time frame: From January 2007 to December 2015 (Up to 9 years; assessed retrospectively)
Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Complete Response as Assessed Using RECIST
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Partial Response as Assessed Using RECIST
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Progressive Disease as Assessed Using RECIST
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants with Stable Disease as Assessed Using RECIST
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
Percentage of Participants With Adverse Events
Time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
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 20 Sep 2019.
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
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 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 3 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 20 Sep 2019. 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 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 With Positive HER2 Test Result (time frame: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)). 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 20 Sep 2019.