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OpenTrials
Completed

NCT Number: NCT07587983

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. real-world (rwPFS) of post-ADC therapy

    Time frame: up to 12 months.

    the duration from the post-ADC treatment initiation to either disease progression or death from any cause, whichever came first

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: at 12 weeks

    ORR was defined as the percentage of patients achieving a best overall response of complete response (CR) or partial response (PR).

  2. Clinical benefit rate (CBR) of post-ADC therapy

    Time frame: 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).

  3. overall survival (OS) of post-ADC therapy

    Time frame: up to 24 months

    Overall survival was defined as the duration from post-ADC treatment initiation to death from any cause.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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