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Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer

8 mei 2026 bijgewerkt door: The First Affiliated Hospital with Nanjing Medical University

Optimal Treatment Strategies for ADC-Resistant HER2-Low Advanced Breast Cancer: A Multicenter, Retrospective Real-World Study

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Borstkanker

Studietype

Observationeel

Inschrijving (Werkelijk)

220

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- Jiangsu
  - Nanjing, Jiangsu, China, 210029
    - The First Affiliated Hospital with Nanjing Medical University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Patients with histologically confirmed HER2-low advanced or metastatic breast cancer who received antibody-drug conjugate (ADC) therapy in the advanced setting and subsequently experienced disease progression.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
real-world (rwPFS) of post-ADC therapy Tijdsspanne: up to 12 months.	the duration from the post-ADC treatment initiation to either disease progression or death from any cause, whichever came first	up to 12 months.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
objective response rate (ORR) Tijdsspanne: at 12 weeks	ORR was defined as the percentage of patients achieving a best overall response of complete response (CR) or partial response (PR).	at 12 weeks
Clinical benefit rate (CBR) of post-ADC therapy Tijdsspanne: at 12 weeks	CBR was determined by the percentage of patients achieving disease control, defined as complete response (CR), partial response (PR), or stable disease (SD).	at 12 weeks
overall survival (OS) of post-ADC therapy Tijdsspanne: up to 24 months	Overall survival was defined as the duration from post-ADC treatment initiation to death from any cause.	up to 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2018

Primaire voltooiing (Werkelijk)

31 december 2025

Studie voltooiing (Werkelijk)