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EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan (EUROPA T-DXd)

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ClinicalTrials.gov Identifier: NCT05458401
Recruitment Status : Recruiting
First Posted : July 14, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment
HER2-positive Breast Cancer Drug: Trastuzumab deruxtecan

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan Through a Named Patient Program (EUROPA T-DXd)
Actual Study Start Date : November 11, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Group/Cohort Intervention/treatment
Trastuzumab Deruxtecan (T-DXd) Cohort
Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
Drug: Trastuzumab deruxtecan
No drug will be administered during this study.
Other Name: T-DXd




Primary Outcome Measures :
  1. Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: 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 Outcome Measures :
  1. Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: Prior to time of T-DXd initiation ]
  2. Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd [ Time Frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months ]
  3. Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months ]
  4. Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: Prior to time of T-DXd initiation ]
    Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.

  5. Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The real world data (RWD) collection will include adult participants with advanced/metastatic HER2+ breast cancer treated in routine clinical practice. The collection of RWD will be optional and independent to eligibility for the NPP. It will include those who have already completed T-DXd treatment under the NPP, as well as patients whose T-DXd treatment remains ongoing.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05458401


Contacts
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Contact: Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT05458401    
Other Study ID Numbers: DS8201-0002-EAP-MA
First Posted: July 14, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Daiichi Sankyo, Inc.:
HER2-positive Breast Cancer
Trastuzumab Deruxtecan
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents