DESTINY-PANTUMOUR04
Purpose
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
Conditions
- 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
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Trastuzumab deruxtecan | 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 |
|
Recruiting Locations
Birmingham, Alabama 35243
Bullhead City, Arizona 86442
Casa Grande, Arizona 85122
San Diego, California 92123
Boulder, Colorado 80309
Coral Springs, Florida 33065
St. Petersburg, Florida 33714
West Palm Beach, Florida 33401
Decatur, Illinois 62526
Topeka, Kansas 66604
Durham, North Carolina 27708
Wilson, North Carolina 27893
Canton, Ohio 44718
Maumee, Ohio 43537
Philadelphia, Pennsylvania 19104
Nashville, Tennessee 37203
Dallas, Texas 75390
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.