Phase 2
N=10
Phase 2 Trial of Selinexor (KPT-330) for Metastatic Triple Negative Breast Cancer (TNBC)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02402764 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Mar 2017
Primary outcome: Primary: Clinical Benefit Rate — 0; 0; 3; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Selinexor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate |
0; 0; 3; 7 | — |
| SECONDARY Best Overall Response (OR) |
— | — |
| SECONDARY Duration of Overall Response |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
1.0 | — |
| SECONDARY Overall Survival (OS) |
6.0 | — |
Summary
The main purpose of this study is to see whether the combination of selinexor (KPT-330) can help people with triple negative breast cancer (TNBC). Researchers also want to study the safety and tolerability of Selinexor in TNBC patients.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed triple negative breast cancer (TNBC), defined as negative immunohistochemical staining for estrogen and progesterone receptors (≤5% of nuclei positive by IHC) and receptor tyrosine-protein kinase erbB-2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology; College of American Pathologists (ASCO-CAP) HER2 Test Guideline Recommendations)
- Written informed consent in accordance with federal, local, and institutional guidelines
- Body surface area ≥1.4 m^2
- Age ≥18 years
- Estimated life expectancy of >3 months at study entry
- TNBC must be either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Documented disease progression at study entry
- Must have received at least 1 chemotherapy regimens in the setting of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Adequate hematological function: Absolute neutrophil count (ANC) > 1500/mm^3, platelets count >100,000mm^3
- Adequate hepatic function within 14 days prior to Cycle 1 Day 1 (C1D1): total bilirubin 2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1)
- Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1
- Coagulation problems and active major bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)
- Active central nervous system (CNS) malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy ≤ 4 weeks prior to Cycle 1 Day 1
- Have not recovered to Grade ≤ 1 or to their baseline from clinically significant adverse effects
Data sourced from ClinicalTrials.gov (NCT02402764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.