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DESTINY-PANTUMOUR04

ConditionsAdenocarcinoma (NOS)Anal CancerBladder CancerCervical CancerEndometrial CancerEsophageal CancerGall Bladder CancerGastrointestinal Stromal TumourHead and Neck CancerLiver CancerMelanomaMouth CancerNasopharangeal CancerNeuroendocrine, Gastrointestinal CancerOvarian CancerPancreatic CancerProstate CancerRenal Cell CarcinomaSalivary Gland CancerSarcomaSmall Cell Lung CancerTesticular CancerThroat CancerThyroid CancerUrethral CancerVaginal CancerVulvar Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years

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);

A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;

HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;

Disqualifiers

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;

Prior T-DXd therapy;

Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.

Patient is participating in a clinical trial at time of enrolment

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Trastuzumab deruxtecan

    Drug

    Trastuzumab deruxtecan monotherapy

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Trastuzumab deruxtecan1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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