A phase II, randomized, multi-center study, assessing value of adding RAD 001 to Trastuzumab as preoperative therapy of HER-2 positive primary breast cancer amenable to surgery - RADHER

FNCLCC0 sites82 target enrollmentOctober 31, 2007

DrugsHERCEPTIN®RAD 001

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: FNCLCC
Enrollment: 82
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 31, 2007

End Date

March 31, 2015

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

FNCLCC

Eligibility Criteria

Inclusion Criteria

•1\) Adult female patients (\= 18 years old),
•2\) Histologically\-confirmed diagnosis of invasive breast cancer, previously untreated (patients who have been treated for cancer of the controlateral breast cancer can be included if there is at least a 2 year time interval from last systemic treatment for breast cancer before randomization into this study),
•3\) Candidate for breast\-conserving surgery; clinical stage: cT1\-3, cN0\-2
•4\) HER\-2 positive primary tumor, defined as: IHC 3\+, or IHC 2\+ and FISH positive (centralized confirmation),
•5\) Clinical stage M0 (bone scan, chest X\-ray, liver ultrasound required at screening to exclude metastatic disease),
•6\) WHO performance status \= 1
•7\) Adequate bone marrow function (WBC \= 3\.5 x109/L; ANC \= 1\.5 x109/L; Platelets \= 100 000x109/L; Hb \=10 g/dL),
•8\) Adequate liver function (serum bilirubin \= 1\.5 ULN, serum transaminases activity \= 2\.5 ULN; alkaline phosphatase \= 2\.5 ULN),
•9\) Adequate renal function (creatinine \= 1\.5 mg/dL or creatine clearance \= 60 mL/min),
•10\) Adequate cardiac (MUGA scan or echocardiography, FEV \> 55%) and pulmonary functions,

Exclusion Criteria

•1\) Patient not candidate for breast conserving surgery or patient candidate to neoadjuvant chemotherapy,
•2\) Patients with inflammatory breast cancer or patient with bilateral breast cancer,
•3\) Patients receiving concomitant anti\-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and radiotherapy,
•4\) Known hypersensitivity to everolimus or sirolimus, to trastuzumab or lactulose,
•5\) \= gr 3 hypercholesterolemia/hypertriglyceridemia or \= gr 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid\-lowering treatment if given),
•6\) Patient with uncontrolled infection,
•7\) Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, chronic liver or renal disease, active GI tract ulceration, severly impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
•8\) Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritonavir, Telithromycin) within the last 5 days prior to randomization,
•9\) Patients with a known history of HIV seropositivity,
•10\) Pregnant women, women who are likely to become pregnant or are breast\-feeding,