An observational study in Adenocarcinoma (NOS), Anal Cancer and Bladder Cancer, sponsored by AstraZeneca. Recruiting at 18 sites in United States. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by AstraZeneca · Observational
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US
This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options will be eligible for inclusion. Patients with breast, colorectal, non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (GEJ) cancers, and haematological malignancies are not eligible for this study.
Approximately 30 sites will be selected including community oncology practices, hospital systems and academic medical centers (AMCs), with a focus on enrolling a patient population representative of real-world care with the majority of patients from community settings. The primary objective of the study is to assess real world response rate and real world duration of response, and the secondary objective is to assess real world time to treatment discontinuation and real world time to next treatment.
The study will enroll patients for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label, but who have not yet started therapy with T-DXd
Exclusion Criteria:
Patients with locally advanced, unresectable, or metastatic HER-2 positive (IHC3+) solid tumours for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label
Drug: Trastuzumab deruxtecan
Trastuzumab deruxtecan monotherapy
Also known as: Enhertu
Real world response rate (rwRR)
rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment
Time frame: Through study completion, up to 2.5 years after enrolment
Real world duration of response (rwDoR)
rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death
Time frame: Through study completion, up to 2.5 years after enrolment
Real world time to treatment discontinuation (rwTTD)
rwTTD is defined as the time from first administration of T-DXd to the date of the clinican decision to discontinue treatment with T-DXd or patient death while on T-DXd therapy
Time frame: Through study completion, up to 2.5 years after enrolment
Real world time to next treatment (rwTTNT)
rwTTNT is defined as the time from the date of first administration of T-DXd to the date of first administration of the next line of treatment or death
Time frame: Through study completion, up to 2.5 years after enrolment
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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