Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGTrastuzumab deruxtecan
Trastuzumab deruxtecan monotherapy
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged ≥18 years 2. 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 as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors); 3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label; 4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent; 5. Patients who are willing and able to provide a signed and dated informed consent.
Exclusion criteria
1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies; 2. Prior T-DXd therapy; 3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd. 4. Patient is participating in a clinical trial at time of enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real world response rate (rwRR) | Through study completion, up to 2.5 years after enrolment | rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment |
| Real world duration of response (rwDoR) | Through study completion, up to 2.5 years after enrolment | rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real world time to treatment discontinuation (rwTTD) | Through study completion, up to 2.5 years after enrolment | 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 |
| Real world time to next treatment (rwTTNT) | Through study completion, up to 2.5 years after enrolment | 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 |
Countries
United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed