Conditions: Breast Cancer
Keywords: Triple Negative Breast Cancer (TNBC) Breast - Female Breast - Male Metastatic Triple Negative Breast Cancer Receptor Tyrosine-protein Kinase erbB-2 (HER2) Negative Erythroblastosis virus oncogene B (erbB)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Screening period (which may last up to 28 days), followed by Selinexor treatment for qualified participants.

During the treatment period, participants will undergo physical examination every 2 weeks until Cycle 6 Day 1 (C6D1), and then every 4 weeks and assessment of tumor response every 8 weeks.

Participants will be treated until progression of disease or the development of unacceptable toxicities. All participants will then undergo a final visit (end of treatment visit).

Interventions: intervention 1: Selinexor
Intervention descriptions: intervention 1: Participants will receive selinexor twice weekly on Monday/Wednesday, Tuesday/Thursday or Wednesday/Friday of Weeks 1, 2 and 3 of each 4-week cycle. Selinexor will not be taken during Week 4. One cycle is defined as 28 days or 6 doses. The starting dose for this trial is 60 mg (flat dose as long as their dose-based body surface area (BSA) analysis does not exceed 70 mg/m\^2).

Protocol document: