Status:
RECRUITING
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Breast Neoplasms
Breast Cancer
Eligibility:
All Genders
18-130 years
Brief Summary
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented ...
Detailed Description
Eligible participants will be those patients with documented HER2-positive, HER2-low or HER2-ultralow unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of pro...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years old
- Patients (irrespective of sex and gender) with pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology
- was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR
- was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR
- was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low.
- Has documented radiologic progression (during or after most recent treatment)
- Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \*
- Patient is able to read and understand either German or English
- Signed written informed consent
- The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.
Exclusion
- Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)
- Known hypersensitivity to T-DXd or any of the excipients of the drug
- Pregnancy or breast feeding
- Current or planned participation in an interventional clinical trial
- Current or planned systemic treatment of any tumor other than unresectable or metastatic BC
- Patients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05573893
Start Date
September 12 2023
End Date
December 31 2031
Last Update
February 27 2026
Active Locations (107)
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1
Research Site
Amberg, Germany, 92224
2
Research Site
Ansbach, Germany, 91522
3
Research Site
Apolda, Germany, 99510
4
Research Site
Aschaffenburg, Germany, 63739