Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:August 10, 2015
End Date:September 19, 2019

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A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and
gemcitabine (carbo/gem) in advanced TNBC patients

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

- 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
We found this trial at
Boston, Massachusetts 02118
Boston, MA
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Clayton, Victoria 3168
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Fayetteville, Arkansas 72703
Fayetteville, AR
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