HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada (NCT06386263) | Clinical Trial Compass
CompletedNot Applicable
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Canada22 participantsStarted 2024-04-22
Plain-language 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.
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.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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:
* 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
Exclusion Criteria (both cohorts):
* 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 Intersti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early treatment discontinuation rates
Timeframe: 3, 6, 9 months
2
Dose modifications
Timeframe: 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)