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.
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Locations near you
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Full eligibility criteria for NCT02402764
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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 hepatic function within 14 days prior to Cycle 1 Day 1 (C1D1): total bilirubin <2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 x ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, AST/ALT ≤5.0 times ULN is acceptable.
Amylase and lipase ≤ 1.5 x ULN
Adequate renal function within 14 days prior to C1D1: estimated creatinine clearance of ≥ 30 mL/min
Women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose. To be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or participants must be surgically sterile.
Must have received prior anthracycline and taxane therapy unless clinically contraindicated
Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the participant's ability to tolerate this therapy
Women who are pregnant or lactating
Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy ≤2 weeks prior to cycle 1 day 1
Major surgery within 4 weeks before Day 1
Unstable cardiovascular function: Electrocardiogram (ECG) abnormalities requiring treatment, or congestive heart failure (CHF) of New York Hearth Association (NYHA) Class ≥3; myocardial infarction (MI) within 3 months
Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Potential participants with controlled infection or on prophylactic antibiotics are permitted in the study.
Known history of HIV
Known active hepatitis A, B, or C infection that requires treatment
Any underlying condition that would significantly interfere with the absorption of an oral medication
Grade >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
All locations for NCT02402764
United States (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Trial results for NCT02402764
Participant Flow: Overall Study
10 / 10
Completed / Started
Serious Adverse Events
3 / 10
Affected / At Risk
Other Adverse Events
10 / 10
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT02402764. The sponsor of the trial is H. Lee Moffitt Cancer Center and Research Institute and it is looking for 10 volunteers for the current phase.
Official trial title: Investigator-Initiated Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Metastatic Triple Negative Breast Cancer
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