Home
Clinical Trials
Safety, Effectiveness and Qua...

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

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-14

Study Completion Date

2024-06-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

NCT06210776

HER2-positive Breast Cancer HER2-low Breast Cancer Breast Cancer +1 more

RECRUITING

Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

NCT02402712

Breast Cancer

COMPLETED PHASE3

Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

NCT05574881

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

NCT05091528

HER2-positive Breast Cancer HER2-positive Gastric Cancer HER2-positive Colorectal Cancer +1 more

TERMINATED PHASE1/PHASE2

Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

NCT04001634

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HER2-positive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.