NCT07035353Not yet recruiting
A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer
A Clinical Study Evaluating the Efficacy and Safety of Real-world T-DXd in Treating Chinese Patients With HER2 Overexpression and HER2 Underexpression Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in China. Cohort A: HER2 overexpressing patients with advanced breast cancer Cohort B: HER2 underexpressing patients with advanced breast cancer A total of 400 subjects will be enrolled in the program, with 200 enrolled in Cohort A and 200 enrolled in Cohort B. The study will be conducted by a physician in accordance with current clinical practice. The treatment plan will be recommended to the subjects by the treating physician based on the current clinical practice guidelines in conjunction with the clinical practice, and the patient's decision to be treated with T-DXd (DS8201) should precede enrollment in this study. Because of the non-interventional nature of this study, this study does not alter or interfere with clinician treatment decisions, and the actual medical practice of patients. Inclusion in the study after the first treatment with the drug is based on inclusion/exclusion criteria. Subject enrollment in this study should be within 2 months of the subject's first dose of medication and prior to the first efficacy assessment. Demographic data, past medical and treatment history, ECOG score, vital signs + physical examination, laboratory tests, objective tumor evaluation, coadministration/concomitant therapy, adverse events, time to progression/death, and subsequent antitumor therapy were collected at baseline, during treatment, and at subsequent follow-up. Imaging evaluation was performed according to RECIST 1.1 criteria. Adverse events evaluation criteria were based on NCI-CTCAE version 5.0.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 12 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- May 2028
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07035353
What you commit to
- Study type: Observational
- Planned participants: 200
- From Jun 2025 to the primary completion date, May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Early stage breast cancer
Other
- Patients who do not meet the criteria for HER2 overexpression and HER2 underexpression.
- Female patients during pregnancy or lactation.
- Patients deemed unsuitable for enrollment by the investigator.
Who the study is looking for
- Must be competent and able to sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved ICF prior to any study-specific procedure or trial.
- Female patients aged ≥18 years with advanced breast cancer who are adults.
- Pathologically confirmed breast cancer that meets the following criteria:
- unresectable or metastatic, with evidence of recurrent or metastatic disease.
- HER2 overexpression, or HER2 hyperexpression as determined by the central laboratory in accordance with the American Society of Clinical Oncology-Society of American Pathologists guidelines.
- Patients must have measurable lesions according to RECIST 1.1 criteria.
- Unmenopausal, menopausal, and perimenopausal female patients were allowed to be enrolled.
- Prior antitumor therapy against recurrent metastatic disease is allowed.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.