RC48-ADC in HER2-low Advanced Breast Cancer

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Advanced Breast Cancer

Treatments

Drug: Disitamab vedotin

Study type

Interventional

Funder types

Other

Identifiers

NCT05831878

LY2023-054-B

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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