HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada

NCT06386263 | Completed FDA Drug

• 1 other identifier: D9673R00032
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Early treatment discontinuation rates

  Summary statistics of cumulative number and proportion of patients discontinuing at each timepoint

  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

  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)

  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

  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

  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)

Study Arms (2)

HER2-positive

This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP.

Drug: Trastuzumab deruxtecan

HER2-low

This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP.

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

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.

Also known as: T-DXd, Enhertu

HER2-low; HER2-positive

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable or metastatic HER2-positive or HER2-low breast cancer enrolled in the PSP who started treatment with T-DXd.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

Research Site

Oakville, Ontario, L6H1A7, Canada

Location

Related Publications (1)

• 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.

  PMID: 40976668 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christine Brezden-Masley

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 26, 2024
• Study Start: April 22, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CA (1)