Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer (NCT07587983) | Clinical Trial Compass
CompletedNot Applicable
Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer
China220 participantsStarted 2018-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* patients previously treated with ADC during neoadjuvant or adjuvant setting.
* patients who had not experienced disease progression on their first ADC (ADC1) regimen and remained on ADC1 treatment.
* patients with no documented subsequent anti-tumor therapy following ADC1 treatment.
* patients who lacked evaluable efficacy assessment data during ADC1 or post-ADC therapy.
* patients with incomplete clinicopathological information.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
real-world (rwPFS) of post-ADC therapy
Timeframe: up to 12 months.
Trial details
NCT IDNCT07587983
SponsorThe First Affiliated Hospital with Nanjing Medical University