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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02435680
Registration number
NCT02435680
Ethics application status
Date submitted
22/04/2015
Date registered
6/05/2015
Titles & IDs
Public title
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
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Scientific title
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
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Secondary ID [1]
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2015-000179-29
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Secondary ID [2]
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CMCS110Z2201
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Universal Trial Number (UTN)
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Trial acronym
TNBC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Triple Negative Breast Cancer (TNBC) With High TAMs
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MCS110
Treatment: Drugs - carboplatin
Treatment: Drugs - gemcitabine
Experimental: Arm 1: MCS110+carboplatin+gemcitabine - MCS110+carboplatin+gemcitabine
Active comparator: Arm 2: carboplatin+gemcitabine - carboplatin+gemcitabine
Treatment: Drugs: MCS110
taken by I.V
Treatment: Drugs: carboplatin
taken by I.V
Treatment: Drugs: gemcitabine
taken by I.V
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
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Assessment method [1]
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PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
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Timepoint [1]
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4 years
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Secondary outcome [1]
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Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
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Assessment method [1]
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AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days
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Timepoint [1]
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day 21 (end cycle 1); day 84 (end cycle 4)
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Secondary outcome [2]
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Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
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Assessment method [2]
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Timepoint [2]
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day 21 (end cycle 1); day 84 (end cycle 4)
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Secondary outcome [3]
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Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
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Assessment method [3]
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day 21 (end cycle 1); day 84 (end cycle 4)
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Timepoint [3]
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day 21, day 84
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Secondary outcome [4]
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AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
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Assessment method [4]
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day 21 (end cycle 1); day 84 (end cycle 4)
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Timepoint [4]
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day 21, day 84
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Secondary outcome [5]
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Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
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Assessment method [5]
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results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. These Biomarker Analyses were performed for MCS110 treated patients only.
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Timepoint [5]
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baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148
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Secondary outcome [6]
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Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
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Assessment method [6]
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results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days.
Biomarker Analyses performed for MCS110 treated patients only.
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Timepoint [6]
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baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148
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Secondary outcome [7]
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Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
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Assessment method [7]
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CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
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Timepoint [7]
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4 years
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Secondary outcome [8]
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Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response
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Assessment method [8]
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CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
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Timepoint [8]
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4 years
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Secondary outcome [9]
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Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
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Assessment method [9]
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patients treated with MCS110 only
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Timepoint [9]
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4 years
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Secondary outcome [10]
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MCS110 Dose Intensity
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Assessment method [10]
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Relative dose intensity by categories.
Patients treated with MCS110 only. The dose intensity measures the dose actually taken versus the planned dose, and is expressed in percentage:
\<50%: less than 50 % of the planned dose received; 50-\<75 %: dose received is 50% or more, but less than 75 %; 75-\<90 %: dose received is 75% or more, but less than 90%; 90-\<110 %: dose received is 90% or more, but less than 110%
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Timepoint [10]
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4 years
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Secondary outcome [11]
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Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
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Assessment method [11]
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results expressed as a the ratio change from baseline expressed in percentage: Biopsies were taken at baseline and between Day 29 and Day 43. Patients treated with MCS110 only
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Timepoint [11]
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Baseline, Day 29-43
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Secondary outcome [12]
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Circulating Monocytes Cells in Blood
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Assessment method [12]
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Cycle duration is 21 days results expressed in percentage of cells. Only 1 arm reported as results were available for 1 patient only.
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Timepoint [12]
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day 15, 29, 43, 50
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/03/2020
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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Austria
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State/province [3]
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Salzburg
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Country [4]
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Austria
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State/province [4]
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Vienna
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Country [5]
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Belgium
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State/province [5]
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Bruxelles
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Country [6]
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France
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State/province [6]
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Paris
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Country [7]
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France
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State/province [7]
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Saint-Herblain Cédex
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Country [8]
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Germany
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State/province [8]
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Berlin
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Country [9]
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Germany
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State/province [9]
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Dresden
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Country [10]
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Germany
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State/province [10]
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Essen
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Country [11]
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Hong Kong
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State/province [11]
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Hong Kong SAR
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Country [12]
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Italy
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State/province [12]
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Bologna
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Country [13]
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Italy
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State/province [13]
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Napoli
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Country [14]
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Korea, Republic of
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State/province [14]
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Korea
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul
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Country [16]
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Spain
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State/province [16]
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Catalunya
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Country [17]
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Spain
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State/province [17]
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Galicia
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Country [18]
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Spain
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State/province [18]
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Barcelona
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Country [19]
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Spain
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State/province [19]
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Madrid
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Country [20]
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Taiwan
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State/province [20]
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Taipei
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Country [21]
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Turkey
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State/province [21]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
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Trial website
https://clinicaltrials.gov/study/NCT02435680
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT02435680/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT02435680/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02435680