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DESTINY-PANTUMOUR04

NCT ID: NCT07124000

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-18

Study Completion Date

2028-03-30

Brief Summary

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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

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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.

Conditions

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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 Endometrial Cancer Adenocarcinoma (NOS) Anal Cancer Bladder Cancer Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Trastuzumab deruxtecan

Intervention Type DRUG

Trastuzumab deruxtecan monotherapy

Interventions

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Trastuzumab deruxtecan

Trastuzumab deruxtecan monotherapy

Intervention Type DRUG

Other Intervention Names

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Enhertu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Birmingham, Alabama, United States

Site Status RECRUITING

Research Site

Casa Grande, Arizona, United States

Site Status RECRUITING

Research Site

Coral Springs, Florida, United States

Site Status RECRUITING

Research Site

Fort Myers, Florida, United States

Site Status RECRUITING

Research Site

O'Fallon, Illinois, United States

Site Status RECRUITING

Research Site

Wilson, North Carolina, United States

Site Status RECRUITING

Research Site

Canton, Ohio, United States

Site Status RECRUITING

Research Site

Maumee, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D781WR00001

Identifier Type: -

Identifier Source: org_study_id