Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients With HER2+ Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients With Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149014
• Other study ID #: 2021-A02007-34
• Status: Recruiting
• Start date: December 14, 2021
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Daiichi Sankyo France
• Contact: Ines FETTAR
• Phone: + 33 1 55 62 15 36
• Email: ines.fettar[@]daiichi-sankyo.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.

Description:

The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adult patient (age = 18 years);

• Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:

• previously treated by compassionate trastuzumab deruxtecan (ATU group), or

• previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);

• Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.

Exclusion Criteria:

• Previous participation in an interventional clinical trial with trastuzumab deruxtecan

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Locations

Country	Name	City	State
France	Clinique des Flandres	Coudekerque-Branche

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest	The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest	2 years following the start of administration of Trastuzumab deruxtecan