NCT05149014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

November 25, 2021

Last Update Submit

September 24, 2024

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Unresectable or metastatic HER2+ breast cancer, treated at least once with trastuzumab deruxtecan

You may qualify if:

  • 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.

You may not qualify if:

  • \- Previous participation in an interventional clinical trial with trastuzumab deruxtecan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique des Flandres

Coudekerque-Branche, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 8, 2021

Study Start

December 14, 2021

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations

FR(1)