Clinical Trials List
Protocol NumberCMCS110Z2201
NCT Number(ClinicalTrials.gov Identfier)NCT02435680
2015-07-10 - 2019-02-12
Phase II
Terminated1
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
A randomized phase II study of MCS110 combined with carboplatin and gemcitabine in advanced Triple Negative Breast Cancer (TNBC)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林季宏 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- Ann-Lii Cheng Division of Hematology & Oncology
- MING-YANG WANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
advanced Triple Negative Breast Cancer (TNBC)
Objectives
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
The primary objective is to assess the anti-tumor activity of MCS110 combined with carbo/gem compared to carbo/gem alone in adult patients with TNBC cancer.
Test Drug
MCS110
Active Ingredient
MCS110
Dosage Form
Concentrate for solution for infusion
Dosage
150mg/7.5mL
Endpoints
Efficacy assessments
Tumor assessment per RECIST v.1.1
Safety assessments
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and ECGs.
Other assessments
MCS110 and carbo/gem pharmacokinetic assessments. Pharmacodynamic markers in blood and tumor
Tumor assessment per RECIST v.1.1
Safety assessments
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and ECGs.
Other assessments
MCS110 and carbo/gem pharmacokinetic assessments. Pharmacodynamic markers in blood and tumor
Inclution Criteria
● Adult women (≥ 20 years of age) with advanced TNBC.
● Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
● ER/PgR negativity to follow local guidelines
● If IHC HER2 2+, a negative FISH test is required
● A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory (approximately 15% of TAMs or above).
● Patients must have:
At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)
● Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
● ER/PgR negativity to follow local guidelines
● If IHC HER2 2+, a negative FISH test is required
● A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory (approximately 15% of TAMs or above).
● Patients must have:
At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)
Exclusion Criteria
Exclusion criteria
● Prior chemotherapy for advanced BC. Previous adjuvant/ neoadjuvant chemotherapy is allowed.
● Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
● Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
● Radiotherapy
● Major surgery
● Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
● Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
● Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
● Patients with the following laboratory values during screening and on Day 1 pre-dose:
● Absolute Neutrophil Count (ANC) < 1.0x109/L
● Hemoglobin < 9 g/dL
● Platelets < 100x109/L
● Serum creatinine > 1.5 x ULN
● Serum total bilirubin > 1.5 x ULN
● AST/SGOT and ALT/SGPT > 3.0 x ULN
● Prior chemotherapy for advanced BC. Previous adjuvant/ neoadjuvant chemotherapy is allowed.
● Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
● Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
● Radiotherapy
● Major surgery
● Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
● Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
● Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
● Patients with the following laboratory values during screening and on Day 1 pre-dose:
● Absolute Neutrophil Count (ANC) < 1.0x109/L
● Hemoglobin < 9 g/dL
● Platelets < 100x109/L
● Serum creatinine > 1.5 x ULN
● Serum total bilirubin > 1.5 x ULN
● AST/SGOT and ALT/SGPT > 3.0 x ULN
The Estimated Number of Participants
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Taiwan
4 participants
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Global
80 participants
