NCT07587983Completed
Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer
Optimal Treatment Strategies for ADC-Resistant HER2-Low Advanced Breast Cancer: A Multicenter, Retrospective Real-World Study
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
This is a multicenter, retrospective real-world study aiming to evaluate the efficacy and safety of post-antibody-drug conjugate (post-ADC) treatment strategies in patients with HER2-low advanced breast cancer who have developed resistance to prior ADC therapy. The study plans to enroll approximately 220 eligible patients from three centers in China (Jiangsu Province Hospital, Nanjing Drum Tower Hospital, and Nanjing General Hospital of Nanjing Military Command) between January 2018 and December 2025. Key efficacy outcomes include progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Safety outcomes include the incidence of grade 3/4 adverse events and serious adverse events. Subgroup analyses will compare different post-ADC regimens (e.g., alternative ADC, chemotherapy, endocrine therapy, immunotherapy) and explore the impact of visceral metastasis and prior ADC treatment response on subsequent outcomes. This study seeks to identify optimal post-ADC treatment strategies and preferred patient populations for clinical benefit.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 220 (actual)
- First submitted
- 14 Apr 2026
- Start date
- 1 Mar 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07587983
What you commit to
- Study type: Observational
- Participants enrolled: 220
- From 1 Mar 2018 to the primary completion date, 31 Dec 2025
- 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
- patients previously treated with ADC during neoadjuvant or adjuvant setting.
- patients with no documented subsequent anti-tumor therapy following ADC1 treatment.
- patients who lacked evaluable efficacy assessment data during ADC1 or post-ADC therapy.
Other illness
- patients who had not experienced disease progression on their first ADC (ADC1) regimen and remained on ADC1 treatment.
Other
- patients with incomplete clinicopathological information.
Who the study is looking for
- females aged ≥18 years.
- confirmed pathologic diagnosis of HER2-low MBC (defined as HER2 IHC 1+ or 2+ without gene amplification by FISH detection).
- patients had disease progression following ADC treatment in advanced setting and had undergone at least one available efficacy evaluation.
- patients received at least one subsequent anti-tumor treatment following ADC failure, with at least one available efficacy evaluation.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.