Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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:
