Advanced Breast Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGDisitamab vedotin
2.0mg/kg, iv, day1, every 2 weeks
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Countries
China
Contacts
CONTACTWenjin Yin, M.D.
PRINCIPAL_INVESTIGATORWenjin Yin, M.D.
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Outcome results
None listed