Breast CancerHERODOTNCT01187381

An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

An observational study of Breast Cancer, run by Hoffmann-La Roche at 1 site in Romania.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Trastuzumab
How many people: 250 participants
Where: 1 siteRomania
Study dates: 14 Apr 2010to 15 Oct 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Study population: Female participants with early or metastatic HER2-positive breast cancer

Who may be able to join

HER2-positive breast cancer
Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
Written informed consent to data collection

Who cannot join

Any contraindication to trastuzumab
Clinically relevant cardiovascular disorder or disease

Trial locations and contacts

1 site in 1 country.

Romania1 site

Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, 400006

Other trials in Romania

About this study

Official title: Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population

This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.

Conditions: Breast Cancer
Being tested: Trastuzumab
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrastuzumabDrug
Also called Herceptin
Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines

Study groups in NCT01187381
Study group	Role	What they receive
Participants with Breast Cancer		Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed. Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician. Receives: Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Duration With Trastuzumab in the Routine Clinical Practice
Measured: Baseline up to 5 years

Secondary outcomes (6)

Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Measured: Baseline up to 5 years
Percentage of Participants Who Received Previous Neoadjuvant Therapy
As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.
Measured: Baseline up to 5 years
Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).
Measured: Baseline up to 5 years
Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
Measured: Baseline up to 5 years
Progression Free Survival
Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.
Measured: Baseline uo tp 5 years
Percentage of Participants by the Site of First Disease Progression
Measured: Baseline 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.

14 Apr 201015 Oct 2015

First posted24 Aug 2010 (estimated)
Study start14 Apr 2010
Primary completion15 Oct 2015
Study completion15 Oct 2015

Why it stopped: Study was prematurely terminated because of missing data collection.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01187381
Sponsor's protocol ID: ML25235
Acronym: HERODOT
Status last verified: May 2017
First submitted: 20 Aug 2010
Last updated: 20 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population
ClinicalTrials.gov ID: NCT01187381
Acronym / sponsor ID: HERODOT / ML25235
Conditions: Breast Cancer
Study type: Observational
Recruitment status: TerminatedReason stopped: Study was prematurely terminated because of missing data collection.
Enrolment: 250 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 14 Apr 2010 (actual)
Primary completion: 15 Oct 2015 (actual)
Study completion: 15 Oct 2015 (actual)
First posted: 24 Aug 2010 (estimated)
Results: Posted 20 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with Breast Cancer	–	Drug: TrastuzumabParticipants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed. Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Female participants with early or metastatic HER2-positive breast cancer

Key inclusion criteria (3 listed)

HER2-positive breast cancer
Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
Written informed consent to data collection

Key exclusion criteria (2 listed)

Any contraindication to trastuzumab
Clinically relevant cardiovascular disorder or disease

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
TrastuzumabAlso: HerceptinTrastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines	Drug	Participants with Breast Cancer

Primary outcome

Treatment Duration With Trastuzumab in the Routine Clinical Practice
Time frame: Baseline up to 5 years

6 secondary outcomes

Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Time frame: Baseline up to 5 years
Percentage of Participants Who Received Previous Neoadjuvant Therapy
Time frame: Baseline up to 5 years
Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Time frame: Baseline up to 5 years
Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
Time frame: Baseline up to 5 years
Progression Free Survival
Time frame: Baseline uo tp 5 years
Percentage of Participants by the Site of First Disease Progression
Time frame: Baseline up to 5 years

Results and safety

Results posted to the registry on 20 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Breast Cancer	250	250

Primary outcome: Treatment Duration With Trastuzumab in the Routine Clinical Practice

Time frame: Baseline up to 5 years. Mean (Standard Deviation). Unit: Days

Measure	Participants With Breast Cancer n = 246
Value	401.90 (229.867)

Population analysed: Number of participant analyzed=participants with data available for this outcome measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Breast Cancer	12 of 250 (4.8%)	17 of 250 (6.8%)	Not reported

Limitations and caveats (from the sponsor): Study was prematurely terminated because of missing data collection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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

1 site 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 1 site in Romania.

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 2 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment Duration With Trastuzumab in the Routine Clinical Practice (time frame: Baseline up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187381.

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 Oct 2017.