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NCT07108595Completed

Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study

Source: ClinicalTrials.gov · Last updated 7 Aug 2025

Brief summary (registry, in English)

Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer

Status (registry)
Completed
Study type
Observational
Enrollment
142 (actual)
First submitted
31 Jul 2025
Start date
1 Jan 2021
Primary completion date
31 Aug 2024
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT07108595

What you commit to

  • Study type: Observational
  • Participants enrolled: 142
  • From 1 Jan 2021 to the primary completion date, 31 Aug 2024
  • 1 site in 1 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.

Prior treatment

  • concurrent malignancies;

Other illness

  • history of interstitial lung disease
  • psychiatric disorders compromising treatment adherence

Other

  • incomplete medical records
  • pregnancy or lactation

Who the study is looking for

  • female patients aged ≥18 years;
  • histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;
  • radiologically confirmed recurrent or metastatic disease;
  • completion of ≥2 cycles of T-DXd therapy;
  • comprehensive medical documentation;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤3;
  • measurable target lesions according to RECIST 1.1

Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jiangsu Provincial People's Hospital, Nanjing, JiangSu 210000
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.