NCT05573893 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
| NCT ID | NCT05573893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2023-09-12 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥ 18 years old 2. 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. 3. Has documented radiologic progression (during or after most recent treatment) 4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \* 5. Patient is able to read and understand either German or English 6. Signed written informed consent * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: 1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date) 2. Known hypersensitivity to T-DXd or any of the excipients of the drug 3. Pregnancy or breast feeding 4. Current or planned participation in an interventional clinical trial 5. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05573893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05573893 currently recruiting?
Yes, NCT05573893 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT05573893 trial being conducted?
This trial is being conducted at Amberg, Germany, Ansbach, Germany, Apolda, Germany, Aschaffenburg, Germany and 11 additional locations.
Who is sponsoring the NCT05573893 clinical trial?
NCT05573893 is sponsored by AstraZeneca. The trial plans to enroll 800 participants.