HER2-positive Breast CancerNCT05149014
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with HER2+ Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Daiichi Sankyo France at 1 site in France.
Trial summary
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2021to 24 Jun 2024
- How long will I take part?
- 2 Years
- 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: Unresectable or metastatic HER2+ breast cancer, treated at least once with trastuzumab deruxtecan
Who may be able to join
- Male or female adult patient (age ≥ 18 years);
- Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:
- previously treated by compassionate trastuzumab deruxtecan (ATU group), or
- previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);
- Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.
Who cannot join
- Previous participation in an interventional clinical trial with trastuzumab deruxtecan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
Read the detailed description
The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.
- Conditions
- HER2-positive Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
Measured: 2 years following the start of administration of Trastuzumab deruxtecan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start14 Dec 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 306 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149014
- Sponsor's protocol ID
- 2021-A02007-34
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients with Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study
- ClinicalTrials.gov ID
- NCT05149014
- Acronym / sponsor ID
- 2021-A02007-34
- Conditions
- HER2-positive Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Daiichi Sankyo FranceIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 8 Dec 2021 (actual)
- 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.
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
Detailed description
The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable or metastatic HER2+ breast cancer, treated at least once with trastuzumab deruxtecan
Key inclusion criteria (5 listed)
- Male or female adult patient (age ≥ 18 years);
- Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:
- Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.
Key exclusion criteria (1 listed)
- Previous participation in an interventional clinical trial with trastuzumab deruxtecan
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 patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
Time frame: 2 years following the start of administration of Trastuzumab deruxtecan
The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
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 26 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HER2-positive Breast Cancer, run by Daiichi Sankyo France at 1 site in France.
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 5 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 26 Sep 2024. 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 France. 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 patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest (time frame: 2 years following the start of administration of Trastuzumab deruxtecan). 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 26 Sep 2024.