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NCT Number: NCT05831878

RC48-ADC in HER2-low Advanced Breast Cancer

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin

CONTACT

[email protected]

86(21)68385569

About this study

Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged ≥18 years
  • Expected survival ≥12 weeks
  • ECOG 0-1
  • Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
  • At least one measurable lesion according to the RECIST 1.1
  • No history of antibody-drug conjugate use
  • Up to one previous chemotherapy for advanced disease
  • Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
  • HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in >0 but ≤10% of tumor cells
  • Adequate organ function

Exclusion criteria

  • History of thromboembolic events
  • Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
  • Active infections requiring systemic treatment
  • Pregnant or lactating
  • Presence of brain metastases and/or carcinomatous meningitis

Treatment and study plan

Disitamab Vedotin

Drug

2.0mg/kg, iv, day1, every 2 weeks

Other names: RC48-ADC

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)

    The percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.

Secondary outcomes

  1. Adverse events

    Time frame: From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year)

    Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
May 13, 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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