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

8. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Studietype

Observasjonsmessig

Registrering (Faktiske)

220

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
real-world (rwPFS) of post-ADC therapy Tidsramme: 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.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
objective response rate (ORR) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2018

Primær fullføring (Faktiske)

31. desember 2025

Studiet fullført (Faktiske)