RC48-ADC in HER2-low Advanced Breast Cancer

RenJi Hospital36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Breast Cancer

Interventions

Disitamab vedotinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

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.

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

Secondary Outcomes

Adverse events

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

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

Central Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569 yinwenjin@renji.com

Data from ClinicalTrials.gov

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