Clinical trials

Completed

A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin in early breast cancer patients who are candidates for surgery

REP0210

What is the purpose of this study?

This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery. This study evaluates the effects of orally administered reparixin on CSCs in the primary tumor and the tumoral microenvironment in an early breast cancer population. The aim is to investigate if cancer stem cells (CSCs) and pathway markers decrease in two early breast cancer subgroups (ER+ and/or progesterone receptor positive/HER-2- and ER negative/progesterone receptor negative/HER-2-) and to compare any differences between the two subgroups to try to better identify a target population. 20 patients will be enrolled to each subgroup at ten sites in the US.

Trial overview

Condition

Early stage operable Breast Cancer

Study Identifiers

NCT01861054

Study type

Interventional

Intervention

Drug: Reparixin

Phase

Pilot

Start date

Feb 2013

End Date

Oct2015

Enrollment Goal

40

Going deep into the trial

Eligibility/Recruitment

Age

≥18 years old

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Study participation will last approximately 2 months. There will be visits to the doctor on Day 1, Day 7, Day 14, and Day 21, and one additional day during the 28 days following the last dose of treatment.

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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