Unresectable Breast CancerHER-TEMPONCT06386263
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
An observational study of Unresectable Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 1 site in Canada.
Trial summary
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer
- What is being tested?
- Trastuzumab deruxtecan
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2024to 7 Jul 2025
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable or metastatic HER2-positive or HER2-low breast cancer enrolled in the PSP who started treatment with T-DXd.
Who may be able to join
- Enrollment criteria for HER2-positive PSP:
- Adults, 18 years of age or older
- Unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy
- Patients must not have received a prior anti-HER2 ADC, such as trastuzumab emtansine, in the metastatic setting
- Patients who received a prior anti-HER2 ADC in the adjuvant setting must have progressed >12 months following the completion of therapy
- Enrollment criteria for HER2-low PSP:
Show all 11Show fewer
- Adults, 18 years of age or older
- Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- Patients with HR+ breast cancer should have received at least one or be considered ineligible for endocrine therapy.
- Patients in the SPP must additionally meet the following criteria:
- Patients must have provided consent to be contacted for future research and provided consent to participate in the current observational study
Who cannot join
- Patients who enrolled in the PSP, but did not initiate therapy with T-DXd by the end of the PSP program
- Patients with medical history of Interstitial Lung Disease (ILD) / pneumonitis that required steroids or current ILD /pneumonitis
- Patients who do not have adequate renal or hepatic function, defined as:
- Inadequate renal function is defined as Creatinine clearance <30 mL/min, as calculated using the Cockcroft-Gault equation .
- Inadequate hepatic function is aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >5 × upper limit of normal (ULN). Total bilirubin >1.5 × ULN if no liver metastases or ≥ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2+ and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.
Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings.
Read the detailed description
This is a non-interventional, observational, hybrid (involving both primary and secondary data), cohort study that is utilizing patient support program (PSP) data. PSPs in Canada can support patients in accessing medicines after Health Canada has granted marketing authorization of a new drug or new indication before public reimbursement is available.
The outcomes will be assessed for the HER2-positive and HER2-low cohorts separately.
The primary objectives include assessing early treatment discontinuation rates at 3-, 6-, and 9-months after initiating T-DXd, and characterizing T-DXd dose modifications (i.e., interruptions and reductions) over the course of treatment for HER2+ mBC and HER2-low mBC.
Secondary objectives include estimating the real-world time to discontinuation (rwTTD) of T-DXd, reasons for treatment discontinuations, and real world duration of treatment and dose intensity with T-DXd.
The primary analysis population for all primary and secondary objectives will be the Total PSP Population (TPP), which includes all patients enrolled into the PSP who meet study criteria. Sensitivity analyses will also be performed in the Study PSP population (SPP), which will be a subset of patients from the TPP who provide study consent for additional data collection.
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Trastuzumab deruxtecan
- Keywords
- Breast Cancer, Metastatic breast cancer, HER-TEMPO, Trastuzumab Deruxtecan, Enhertu®, Observational
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called T-DXd, Enhertu
This is a non-interventional, observational study. Patients who are enrolled by their clinician will receive T-DXd per routine clinical practice through the PSP.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive | This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP. Receives: Drug: Trastuzumab deruxtecan | |
| HER2-low | This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP. Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early treatment discontinuation rates
Summary statistics of cumulative number and proportion of patients discontinuing at each timepoint
Measured: 3, 6, 9 months
Dose modifications
Summary statistics about number and proportion of patients experiencing a dose modification (reduction or interruption) while receiving treatment in the PSP
Measured: from baseline to treatment discontinuation or the end of PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
Secondary outcomes (3)
Real world time to treatment discontinuation (rwTTD)
Median time from first dose of T-DXd to earliest date of T-DXd discontinuation as recorded in the patient support program (PSP) database or self-report from follow-up, or death, whichever occurs first
Measured: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Reasons for treatment discontinuations
Summary statistics about the number and proportion of patients with pre-specified reasons for treatment discontinuations as recorded by the clinician in the PSP program or based on self-report
Measured: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Median treatment duration and dose intensity
Median treatment duration (and range, 95% CI): time from treatment initiation to treatment discontinuation excluding any dose interruptions; and dose intensity (DI) will be measured by the total drug delivered over the total time for the course of treatment (RDI will be the ratio of DI to the standard dose intensity)
Measured: from baseline to treatment discontinuation (as recorded in the PSP database) or end of the PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start22 Apr 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Christine Brezden-Masley, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386263
- Sponsor's protocol ID
- D9673R00032
- Acronym
- HER-TEMPO
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Brezden-Masley C, Qadeer R, Senhaji Mouhri Z, Salvo B, Bonar N, Spin P, Shokar S. Canadian real-world hybrid longitudinal cohort study of treatment discontinuations and modifications for patients with HER2+ and HER2-low metastatic breast cancer on trastuzumab deruxtecan enrolled in a patient support programme: the HER-TEMPO study protocol. BMJ Open. 2025 Sep 21;15(9):e100889. doi: 10.1136/bmjopen-2025-100889.
PubMed 40976668
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2+ and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan
- ClinicalTrials.gov ID
- NCT06386263
- Acronym / sponsor ID
- HER-TEMPO / D9673R00032
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Keywords
- Breast Cancer, Metastatic breast cancer, HER-TEMPO, Trastuzumab Deruxtecan, Enhertu®, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 26 Apr 2024 (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.
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.
Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings.
Detailed description
This is a non-interventional, observational, hybrid (involving both primary and secondary data), cohort study that is utilizing patient support program (PSP) data. PSPs in Canada can support patients in accessing medicines after Health Canada has granted marketing authorization of a new drug or new indication before public reimbursement is available.
The outcomes will be assessed for the HER2-positive and HER2-low cohorts separately.
The primary objectives include assessing early treatment discontinuation rates at 3-, 6-, and 9-months after initiating T-DXd, and characterizing T-DXd dose modifications (i.e., interruptions and reductions) over the course of treatment for HER2+ mBC and HER2-low mBC.
Secondary objectives include estimating the real-world time to discontinuation (rwTTD) of T-DXd, reasons for treatment discontinuations, and real world duration of treatment and dose intensity with T-DXd.
The primary analysis population for all primary and secondary objectives will be the Total PSP Population (TPP), which includes all patients enrolled into the PSP who meet study criteria. Sensitivity analyses will also be performed in the Study PSP population (SPP), which will be a subset of patients from the TPP who provide study consent for additional data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2-positive | – | Drug: Trastuzumab deruxtecanThis cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP. |
| HER2-low | – | Drug: Trastuzumab deruxtecanThis cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable or metastatic HER2-positive or HER2-low breast cancer enrolled in the PSP who started treatment with T-DXd.
Key inclusion criteria (11 listed)
- Adults, 18 years of age or older
- Unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy
- Patients must not have received a prior anti-HER2 ADC, such as trastuzumab emtansine, in the metastatic setting
- Patients who received a prior anti-HER2 ADC in the adjuvant setting must have progressed >12 months following the completion of therapy
- Adults, 18 years of age or older
Key exclusion criteria (5 listed)
- Patients who enrolled in the PSP, but did not initiate therapy with T-DXd by the end of the PSP program
- Patients with medical history of Interstitial Lung Disease (ILD) / pneumonitis that required steroids or current ILD /pneumonitis
- Patients who do not have adequate renal or hepatic function, defined as:
- Inadequate renal function is defined as Creatinine clearance <30 mL/min, as calculated using the Cockcroft-Gault equation .
- Inadequate hepatic function is aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >5 × upper limit of normal (ULN). Total bilirubin >1.5 × ULN if no liver metastases or ≥ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
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 |
|---|---|---|
| Trastuzumab deruxtecanAlso: T-DXd, EnhertuThis is a non-interventional, observational study. Patients who are enrolled by their clinician will receive T-DXd per routine clinical practice through the PSP. | Drug | HER2-low, HER2-positive |
Primary outcome
Early treatment discontinuation rates
Time frame: 3, 6, 9 months
Summary statistics of cumulative number and proportion of patients discontinuing at each timepoint
Dose modifications
Time frame: from baseline to treatment discontinuation or the end of PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
Summary statistics about number and proportion of patients experiencing a dose modification (reduction or interruption) while receiving treatment in the PSP
3 secondary outcomes
Real world time to treatment discontinuation (rwTTD)
Time frame: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Reasons for treatment discontinuations
Time frame: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Median treatment duration and dose intensity
Time frame: from baseline to treatment discontinuation (as recorded in the PSP database) or end of the PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
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 8 Jul 2026.
- Derived from this study: PubMed 40976668Brezden-Masley C, Qadeer R, Senhaji Mouhri Z, Salvo B, Bonar N, Spin P, Shokar S. Canadian real-world hybrid longitudinal cohort study of treatment discontinuations and modifications for patients with HER2+ and HER2-low metastatic breast cancer on trastuzumab deruxtecan enrolled in a patient support programme: the HER-TEMPO study protocol. BMJ Open. 2025 Sep 21;15(9):e100889. doi: 10.1136/bmjopen-2025-100889.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
Christine Brezden-Masley principal investigator
Sinai Health System
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 Unresectable Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 1 site 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 11 inclusion and 5 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 8 Jul 2026. 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 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?
Early treatment discontinuation rates (time frame: 3, 6, 9 months). The study lists 2 primary outcomes in all. 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 NCT06386263, which also lists 1 linked publication.
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 8 Jul 2026.