Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring estrogen receptor-positive breast cancer, HER2-negative breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast carcinoma meeting the following criteria:
- Estrogen receptor-positive ≥ 50% or Allred score > 6
- HER-2 negative defined as IHC < 2+ and negative FISH/CISH
- Primary tumor measuring ≥ 3 cm if there is no node involvement
Any T if N1 or N2 disease
- No inflammatory breast cancer (T4d)
- No metastatic disease
- Measurable disease by mammography and/or ultrasound and MRI (if available)
PATIENT CHARACTERISTICS:
Postmenopausal
- Prior bilateral oophorectomy
- ≥ 60 years of age
- < 60 years of age AND have experienced amenorrhea for ≥ 12 months in the absence of chemotherapy, tamoxifen, or toremifene OR have undergone ovarian suppression and follicle-stimulating hormone and estradiol levels in the postmenopausal range
- ECOG performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Albumin > 2.5. g/dL
- No known HIV infection
- Adequate left ventricular ejection fraction (LVEF) at baseline defined as LVEF not below normal range by echocardiogram or MUGA
No evidence of prior uncontrolled hypertension
- Patients with controlled hypertension (systolic < 150 mm Hg and/or diastolic < 90 mm Hg) by antihypertensive therapies allowed
- No prior uncontrolled or symptomatic angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, or prolongation of the QTc interval
- No hemorrhagic or thrombotic events, including transient ischemic attack, pulmonary embolism, or deep-vein thrombosis, within the past 12 months
- No gross hemorrhage within the past 6 months (e.g., gastrointestinal bleeding, hemoptysis, or hematuria)
- No history or evidence of an inherited bleeding diathesis or coagulopathy at risk of bleeding
None of the following:
- Unable to swallow oral medications
- Active inflammatory bowel disease
- Partial or complete bowel obstruction
- Chronic diarrhea
- No history of another malignancy within the past 5 years except for cured non-melanoma skin cancer or successfully treated carcinoma in situ of the cervix
- No psychiatric disease or social situations that would limit compliance with study requirements or patient unwilling or unable to comply with protocol for the duration of study
- No unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the achievement of study objectives
- No known immediate or delayed hypersensitive reaction or idiosyncrasy to drugs chemically related to exemestane or sunitinib malate or their excipients
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior or other concurrent chemotherapy, radiotherapy, immunotherapy, biologic therapy, or hormonal therapy for primary invasive breast cancer
- No concurrent anticoagulant therapy except for low-dose anticoagulants (i.e., low molecular weight heparin or aspirin) for the prevention of deep-vein thrombosis
- No chronic therapy with corticosteroids, except for steroids administered by inhalation
- More than 4 weeks since prior major surgery and ≥ 7 days since prior minor surgery
- No prior or other concurrent investigational anticancer agent
- No concurrent participation in another clinical trial
- No concurrent drugs with potential proarrhythmic activity
- No concurrent known CYP3A4 inhibitors (i.e., grapefruit, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, diltiazem, nefazodone, voriconazole, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, delavirdine)
- No concurrent known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, efavirenz, tipranavir, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, St. John's wort)
Sites / Locations
- Institut Catala D'OncologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group 1
Group 2
Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.