A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones
- Conditions
- Advanced Triple Negative Breast CancerMedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000179-29-AT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 78
- 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-) BC 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 (approximately 15% of TAMs or above).
- 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)
or
- Bone lesions: non-measurable lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above. Patients with only non-measurable lesions (e.g. pleural effusion, ascites) and no lytic or mixed bone lesions are not eligible.
Other inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
- Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed.
- 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 dose of study drug.
- 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 pre-dose:
- Absolute Neutrophil Count (ANC) < 1.0x109/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
Other exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.;Secondary Objective: 1. Characterize the safety and tolerability of MCS110 given in combination with carbo/gem.<br>2. Characterize PK of MCS110 when combined with carbo/gem.<br>3. Characterize PK of carbo and gem in the presence and absence of MCS110.<br>4. Characterize PD effect of MCS110 when combined with carbo/gem<br>5. To assess the anti-tumor activity of MCS110 given in combination with carbo/gem as measured by additional efficacy measures.;Primary end point(s): PFS as per RECIST v1.1 (by local investigator assessment);Timepoint(s) of evaluation of this end point: Tumor evaluation at sreening and then every six weeeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
- Secondary Outcome Measures
Name Time Method