A ReaL World Study of DS-8201 (EXPLORE)

April 18, 2025 updated by: Jian Zhang,MD, Fudan University

Trastuzumab-deruxtecan In Metastatic Breast Cancer Patients: A ReaL World Study of Chinese Population

A ReaL world study of DS-8201

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients who received DS-8201 in the advanced stage

Description

Inclusion Criteria:

  1. Male or female aged 18 or above;
  2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
  3. HER2 positive (IHC 3+ or IHC 2+ and ISH+) confirmed by tumor histology or cytology, and having received one or more anti-HER2 drug treatments previously; Or low expression of HER2 confirmed by tumor histology or cytology (IHC 1+ or IHC 2+ and ISH-), and having received at least one systemic treatment in the metastatic disease stage previously, or unresectable or metastatic breast cancer that relapsed during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy;
  4. Receive goldtrastuzumab treatment in the advanced stage;
  5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
  6. All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;
  3. Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.
  4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
  5. Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;
  6. Patients allergic to trastuzumab;
  7. Patients who changed their treatment regimens after trastuzumab treatment due to reasons other than disease progression or intolerable adverse reactions;
  8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients received DS-8201
HER2-positive and HER2-low breast cancer patients who received DS-8201 in the advanced stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Six months after the last patient was enrolled
PFS was defined as the time interval from the date of DS-8201 initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
Six months after the last patient was enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPLORE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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