Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Everolimus; Sirolimus; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of invasive breast cancer

• Previously untreated disease

• Candidate for breast-conserving surgery, as defined by both of the following:

• Clinical stage cT1-3, cN0-2 disease

• Clinical stage M0 disease (bone scan, chest X-ray, and liver ultrasound required at screening to exclude metastatic disease)

• HER2-positive primary tumor, defined as meeting either of the following criteria:

• IHC 3+

• IHC 2+ and FISH positive (centralized confirmation)

• No inflammatory breast cancer or bilateral breast cancer

• Patients who have been treated for cancer of the contralateral breast can be included if there is at least a 5 year time interval from last systemic treatment for breast cancer before randomization into this study

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Menopausal status not specified

• WBC ≥ 3.5 x 10^9/L

• ANC ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Hb ≥ 10 g/dL

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Serum transaminases activity ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

• FEV > 55% by MUGA or ECHO

• Spirometry and DLCO > 50% of normal

• O_2 saturation > 88% at rest on room air

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known hypersensitivity to everolimus, sirolimus, trastuzumab (Herceptin®), or lactulose

• No hypercholesterolemia/hypertriglyceridemia ≥ grade 3

• No hypercholesterolemia/hypertriglyceridemia ≥ grade 2 with history of coronary artery disease (despite lipid-lowering treatment if given)

• No uncontrolled infection

• No other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including any of the following:

• Uncontrolled hypertension

• Congestive cardiac failure

• Ventricular arrhythmias

• Active ischemic heart disease

• Myocardial infarction within the past year

• Chronic liver or renal disease

• Active gastrointestinal tract ulceration

• Severely impaired lung function

• No known history of HIV seropositivity

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Willing to participate in the biological investigations

• Not deprived of liberty or placed under guardianship

• Patients must be affiliated to a Social Security System

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 30 days (from the screening visit) since prior other investigational drugs

• More than 5 days (from randomization) since prior and no concurrent strong inhibitors or inducers of the isoenzyme CYP3A, including any of the following

• Rifabutin

• Rifampicin

• Clarithromycin

• Ketoconazole

• Itraconazole

• Voriconazole

• Ritonavir

• Telithromycin

• No other concurrent anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy, or radiotherapy