Breast CancerNCT01991340
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 19 sites in 2 countries.
Trial summary
This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 657 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Nov 2008to Feb 2013
- 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: Patients with HER2-positive breast cancer eligible for treatment with Herceptin
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically confirmed HER2-positive breast cancer
- Eligible to receive Herceptin as per Summary of Product Characteristics
Who cannot join
- Contra-indications according to Summary of Product Characteristics
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Morocco12 sites
Study site
Agadir, 80000
Study site
Casablanca, 20000
Study site
Casablanca, 20052
Study site
Casablanca, 20100
Study site
Casablanca, 20502
Study site
Casablanca
Study site
Fes, 30000
Study site
Marrakesh, 40000
Study site
Rabat, 10000
Study site
Rabat, 21000
Study site
Rabat, 6213
Study site
Rabat
Algeria7 sites
Study site
Algiers, 16000
Study site
Annaba, 23000
Study site
Blida, 9000
Study site
Mascara, 29000
Study site
Oran, 31000
Study site
Sidi Belabes, 22000
Study site
Tizi Ouzou, 15000
About this study
Official title: H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.
- 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 |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: up to approximately 4.5 years
Secondary outcomes (3)
Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)
Measured: up to approximately 4.5 years
Incidence of asymptomatic LVEF decline
Measured: up to approximately 4.5 years
Frequency of treatment discontinuations/interruptions
Measured: up to approximately 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2008
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Prospective
- Enrolment
- 657 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
- NCT01991340
- Sponsor's protocol ID
- ML21975
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
- ClinicalTrials.gov ID
- NCT01991340
- Acronym / sponsor ID
- ML21975
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Nov 2013 (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 study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2-positive breast cancer eligible for treatment with Herceptin
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Histologically confirmed HER2-positive breast cancer
- Eligible to receive Herceptin as per Summary of Product Characteristics
Key exclusion criteria (1 listed)
- Contra-indications according to Summary of Product Characteristics
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
Safety: Incidence of adverse events
Time frame: up to approximately 4.5 years
3 secondary outcomes
Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)
Time frame: up to approximately 4.5 years
Incidence of asymptomatic LVEF decline
Time frame: up to approximately 4.5 years
Frequency of treatment discontinuations/interruptions
Time frame: up to approximately 4.5 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 25 Nov 2013.
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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
19 sites in 2 countries: 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 19 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 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Morocco, Algeria. 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?
Safety: Incidence of adverse events (time frame: up to approximately 4.5 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 25 Nov 2013.