Breast Cancer Stage IVNCT04566458
RWD Study in HER2+ mBC Patients in Third-Line Therapy
An observational study of Breast Cancer Stage IV, run by Exactis Innovation at 8 sites in Canada.
Trial summary
This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage IV
- How many people
- 63 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Oct 2020to 30 May 2021
- 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: The study population in this study will include up to 100 patients with HER2+ mBC having completed at least two previous lines of anti-HER2 based therapy or a combination of anti-HER2 based therapy and chemotherapy and ongoing third or additional lines of treatment.
Who may be able to join
- Male or female patients (≥18 years of age)
- Patients with stage IV breast cancer
- Patients with HER2+ status in metastatic setting
- Patients that received at least two lines of active anti-cancer drugs due to disease progression.
- Patients that began third-line therapy prior to October 31, 2018.
Who cannot join
- Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick
The Moncton Hospital
Moncton, New Brunswick
CHUM- Centre hospitalier de l'universite de Montreal
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
CHUQ- Centre hospitalier universitaire de Québec
Québec, Quebec
CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont
Sherbrooke, Quebec
Sunnybrook Health Center
Toronto, Ontario
About this study
Official title: Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.
Read the detailed description
The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.
- Conditions
- Breast Cancer Stage IV
- Being tested
- No intervention
- Keywords
- HER2 positive, Real World Data, Metastatic Breast cancer, Real World Evidence
- 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
Also called No treatment was administered
retrospective chart review study
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada
The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
Measured: up to 2 years
To describe the brain metastatic HER2+ mBC subpopulation during third line
The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified.
Measured: up to 2 years
To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.
The proportion of each type of radiation therapy received during third line, the time between brain metastasis detection and whole brain radiation (WBR), and the proportion of patients receiving a second WBR before death will be quantified.
Measured: up to 2 years
To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.
The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.
Measured: up to 2 years
To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada
The median PFS in third-line HER2+ mBC patients will be quantified.
Measured: up to 2 years
To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada
The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .
Measured: up to 2 years
To assess HRU for HER2+ mBC patients in Canada during third-line therapy.
Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Oct 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies 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
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactis Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- Knight Therapeutics
- Responsible party
- Sponsor
- Investigators
- Gerald Batist, Principal investigator, Exactis Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566458
- Sponsor's protocol ID
- Exactis-05
- Status last verified
- Feb 2021
- First submitted
- 22 Sep 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
- ClinicalTrials.gov ID
- NCT04566458
- Acronym / sponsor ID
- Exactis-05
- Conditions
- Breast Cancer Stage IV
- Keywords
- HER2 positive, Real World Data, Metastatic Breast cancer, Real World Evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Exactis InnovationUniversity, hospital or other
- Collaborators
- Knight Therapeutics
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 28 Sep 2020 (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.
This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.
Detailed description
The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: No interventionHer2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population in this study will include up to 100 patients with HER2+ mBC having completed at least two previous lines of anti-HER2 based therapy or a combination of anti-HER2 based therapy and chemotherapy and ongoing third or additional lines of treatment.
Key inclusion criteria (5 listed)
- Male or female patients (≥18 years of age)
- Patients with stage IV breast cancer
- Patients with HER2+ status in metastatic setting
- Patients that received at least two lines of active anti-cancer drugs due to disease progression.
- Patients that began third-line therapy prior to October 31, 2018.
Key exclusion criteria (1 listed)
- Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
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 interventionAlso: No treatment was administeredretrospective chart review study | Other | Single arm |
Primary outcome
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada
Time frame: up to 2 years
The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
To describe the brain metastatic HER2+ mBC subpopulation during third line
Time frame: up to 2 years
The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified.
To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.
Time frame: up to 2 years
The proportion of each type of radiation therapy received during third line, the time between brain metastasis detection and whole brain radiation (WBR), and the proportion of patients receiving a second WBR before death will be quantified.
To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.
Time frame: up to 2 years
The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.
To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada
Time frame: up to 2 years
The median PFS in third-line HER2+ mBC patients will be quantified.
To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada
Time frame: up to 2 years
The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .
To assess HRU for HER2+ mBC patients in Canada during third-line therapy.
Time frame: up to 2 years
Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.
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 7 Oct 2021.
- Individual participant dataSharing planned: Yes. The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.
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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.
Gerald Batist principal investigator
Exactis Innovation
8 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 Stage IV, run by Exactis Innovation at 8 sites in Canada.
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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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?
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada (time frame: up to 2 years). The study lists 7 primary outcomes in all. 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 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.