Status:
TERMINATED
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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....
Detailed Description
According to the cancer stem cell (CSC) model, tumors are organized in a cellular hierarchy maintained by a subpopulation of cells displaying stem cell properties. These properties include self-renewa...
Eligibility Criteria
Inclusion
- Female aged \> 18 years.
- Patients with operable breast cancer, with measurable tumors of more than 1 cm in diameter, that are not candidates for neoadjuvant therapy.
- Zubrod (Eastern Co-operative Oncology Group \[ECOG\]) Performance Status (PS) of 0-1.
- No prior treatment by surgery, radiotherapy, hormone therapy e.g. TAMOXIFEN® or RALOXIFEN® for prevention or chemotherapy.
- Scheduled to undergo definitive local surgery for breast cancer.
- Patients must be willing to undergo two mandatory tumor biopsies (pre and post therapy) that are not required for standard care. A sample of tumor tissue removed during surgery will also be collected for analysis.
- Patients must be able to swallow and retain oral medication (intact tablet).
- Able to undergo all screening assessments outlined in the protocol after giving informed consent.
- Adequate organ function (defined by the following parameters):
- Serum creatinine \< 140 μmol/L or creatinine clearance \> 60 mL/min.
- Serum hemoglobin \> 9 g/dL; absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L.
- Serum bilirubin \< upper normal limit (UNL).
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ UNL; alkaline phosphatase (ALP) ≤ UNL; albumin within normal limits.
- Documented hormone receptor (ER and progesterone receptor) and HER-2- status.
- No known hepatitis B virus (unless due to immunization), hepatitis C virus, human immune deficiency virus-I and II positive status.
Exclusion
- Male.
- Pregnancy or lactation or unwillingness to use two adequate methods of birth control throughout the study and for 30 days after study discontinuation.
- Any other breast cancer types including inflammatory form.
- Prior surgery to the breast area or primary axillary dissection.
- Prior treatment for breast cancer.
- Use of an investigational drug within 30 days preceding the first dose of study medication.
- Any prior or current cancer, except in situ uterine carcinoma or basocellular cutaneous cancer considered as definitively cured.
- Any associated medical condition considered incompatible with the study, e.g. cardiac, renal, medullar, respiratory or hepatic insufficiency.
- Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.
- Active or uncontrolled infection.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function.
- Hypersensitivity to:
- ibuprofen or to more than one non-steroidal anti-inflammatory drug;
- medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01861054
Start Date
February 1 2013
End Date
March 1 2016
Last Update
May 14 2021
Active Locations (9)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
2
University of Kansas Cancer Center, 4350 Shawnee Mission Pkwy, Suite 1500, Mailstop 6004
Fairway, Kansas, United States, 66205
3
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
4
Weill Cornell Medical College
New York, New York, United States, 10065