Breast Cancer Clinical Trial
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Summary
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
Eligibility Criteria
Inclusion Criteria:
Adult women (≥ 18 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
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:
Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
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 predose:
Absolute Neutrophil Count (ANC) < 1.5x109/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
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There are 22 Locations for this study
Fayetteville Arkansas, 72703, United States
Boston Massachusetts, 02114, United States
Nedlands Western Australia, 6009, Australia
Salzburg , 5020, Austria
Vienna , 1090, Austria
Vienna , A-109, Austria
Bruxelles , 1200, Belgium
Paris , 75231, France
Saint-Herblain Cédex , 44805, France
Berlin , 10967, Germany
Dresden , 01307, Germany
Essen , 45136, Germany
Hong Kong SAR , , Hong Kong
Bologna , 40138, Italy
Napoli , 80131, Italy
Seoul Korea, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Barcelona Catalunya, 08035, Spain
Santiago de Compostela Galicia, 15706, Spain
Barcelona , 08041, Spain
Madrid , 28050, Spain
Taipei , 10002, Taiwan
Istanbul , 35100, Turkey
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