Clinical trial · Interventional
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
A Randomized Phase II Study of MCS110 Combined With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
NCT02435680CI-TRIAL-00052369TNBCcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Triple Negative Breast Cancer (TNBC) With High TAMs | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| MCS110 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: MCS110+carboplatin+gemcitabine
- description
- MCS110+carboplatin+gemcitabine
- interventionNames
- Drug: MCS110
- Drug: carboplatin
- Drug: gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: carboplatin+gemcitabine
- description
- carboplatin+gemcitabine
- interventionNames
- Drug: carboplatin
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available
No reference posted for this study.