Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
NCT ID: NCT02435680
Last Updated: 2021-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2015-08-10
2020-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: MCS110+carboplatin+gemcitabine
MCS110+carboplatin+gemcitabine
MCS110
taken by I.V
carboplatin
taken by I.V
gemcitabine
taken by I.V
Arm 2: carboplatin+gemcitabine
carboplatin+gemcitabine
carboplatin
taken by I.V
gemcitabine
taken by I.V
Interventions
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MCS110
taken by I.V
carboplatin
taken by I.V
gemcitabine
taken by I.V
Eligibility Criteria
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Inclusion 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
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Massachusetts General Hospital Cancer Center SC
Boston, Massachusetts, United States
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Saint-Herblain Cédex, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hong Kong SAR, , Hong Kong
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-000179-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMCS110Z2201
Identifier Type: -
Identifier Source: org_study_id
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