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

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT02435680

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 22 Locations for this study

See Locations Near You

Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Massachusetts General Hospital Cancer Center SC
Boston Massachusetts, 02114, United States
Novartis Investigative Site
Nedlands Western Australia, 6009, Australia
Novartis Investigative Site
Salzburg , 5020, Austria
Novartis Investigative Site
Vienna , 1090, Austria
Novartis Investigative Site
Vienna , A-109, Austria
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Paris , 75231, France
Novartis Investigative Site
Saint-Herblain Cédex , 44805, France
Novartis Investigative Site
Berlin , 10967, Germany
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Essen , 45136, Germany
Novartis Investigative Site
Hong Kong SAR , , Hong Kong
Novartis Investigative Site
Bologna , 40138, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Seoul Korea, 05505, Korea, Republic of
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Santiago de Compostela Galicia, 15706, Spain
Novartis Investigative Site
Barcelona , 08041, Spain
Novartis Investigative Site
Madrid , 28050, Spain
Novartis Investigative Site
Taipei , 10002, Taiwan
Novartis Investigative Site
Istanbul , 35100, Turkey

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT02435680

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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