HER-TEMPO - Real world treatment-related outcomes on T-DXd in Canada - HER-TEMPO

Study identifier:D9673R00032

ClinicalTrials.gov identifier:NCT06386263

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Real world study of TrEatment discontinuations and Modifications for Patients with HER2+ and HER2-low metastatic breast cancer On trastuzumab deruxtecan

Medical condition

Unresectable Breast Cancer

Phase

N/A

Healthy volunteers

Study drug

Trastuzumab deruxtecan

Sex

All

Estimated Enrollment

Study type

Observational

Age

18 Years - 130 Years

Date

Study Start Date: 22 Apr 2024

Estimated Primary Completion Date: 04 Apr 2025

Estimated Study Completion Date: 04 Apr 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria

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 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.

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Arms	Assigned Interventions
HER2-positive This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP.	Drug: Trastuzumab deruxtecan 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. Other Name: T-DXd Other Name: Enhertu
HER2-low This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP.	Drug: Trastuzumab deruxtecan 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. Other Name: T-DXd Other Name: Enhertu

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Amyn Sayani

4168931724