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

Phase 1

• Conditions: Advanced Triple Negative Breast Cancer; MedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000179-29-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-01
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 78

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-) 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.
- 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 + blastic) 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

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
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) < 1.5x10^9/L
- Hemoglobin < 9 g/dL
- Platelets < 100x10^9/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).