HER2-positive Breast Cancer
Conditions
Keywords
HER2-positive Breast Cancer, Trastuzumab Deruxtecan
Brief summary
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.
Detailed description
The antibody-drug conjugate T-DXd has been granted conditional approval in the European Union as a single agent for adult patients with unresectable or metastatic HER2+ breast cancer who have previously received ≥2 HER2-based regimens. This was based on data from the Phase II DESTINY-Breast01 trial (NCT03248492). DS8201-0002-EAP-MA is a real world data (RWD) observational data collection inviting patients with advanced/metastatic HER2+ breast cancer receiving T-DXd through the NPP already to participate to help further understand the usage in a real world clinical setting.
Interventions
DRUGTrastuzumab deruxtecan
No drug will be administered during this study.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate.
Exclusion criteria
* Any participant who does not meet all inclusion criteria noted above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months | Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from trastuzumab deruxtecan initiation to discontinuation for any reason in patients with advanced/metastatic HER2+ breast cancer in a real-world clinical setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | Prior to time of T-DXd initiation | — |
| Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd | From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months | — |
| Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months | — |
| Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | Prior to time of T-DXd initiation | Patients who received prophylaxis treatment for nausea and/or vomiting will be reported. |
| Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd) | From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months | Real world progression-free survival (rwPFS) is defined as the time from T-DXd initiation to the earliest of death or progression. |
Countries
Ireland, Italy, Spain
Outcome results
None listed