RecruitingPhase not listed

DESTINY-PANTUMOUR04

Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This US study looks at how well T-DXd works in routine care for adults with HER2-positive solid tumors that have grown nearby, cannot be removed by surgery, or have spread. It is for people who have already had treatment for advanced cancer and have no other suitable treatment options.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have a solid tumor that has grown nearby, cannot be removed by surgery, or has spread to other parts of the body.
  • Local testing before you join shows high levels of a protein called HER2 in your tumor (IHC 3+).
  • You have had treatment that works throughout the body for advanced cancer or cancer that has spread.
  • The study doctor has decided there are no other suitable treatment options.
  • Your clinician has decided to treat you with T-DXd following its FDA-approved instructions.
  • You are willing and able to sign and date a form agreeing to join the study.

Who can't join

  • Your main cancer is adenocarcinoma (cancer that starts in gland cells) of the breast, colon, rectum, main part of the stomach, or the area where the food pipe meets the stomach.
  • Your main cancer is non-small cell lung cancer or a blood cancer.
  • You have received T-DXd before.
  • You have not had a check of how much cancer is in your body before starting T-DXd.
  • You are taking part in a clinical trial when you join this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (18)

AL

AZ

CA

CO

FL

IL

KS

NC

NM

OH

PA

TN

TX