Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

NCT00482755 | Completed Phase 2 DMC

• 4 other identifiers: MA29CAN-NCIC-MA29PFIZER-CAN-NCIC-MA29CDR0000547161
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Sunitinib 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with newly diagnosed stage II or stage IIIA breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

male breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility

Secondary Outcomes (7)

• Nature, severity, and frequency of adverse events

• Activity (response rate)

• Markers of angiogenesis pre- and post-treatment

• Role of both host- and tumor-specific genes pertaining to response and toxicity

• Comparison of tumor vascular parameters pre- and post-treatment

Interventions

sunitinib malate DRUG

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

needle biopsy PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Newly diagnosed disease * Stage II-IIIA (T1c, T2, or T3) disease * Unifocal disease * Resectable disease * Tumor must be suitable for multiple biopsies and imaging * No prior breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 0-1 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine normal * Calcium ≤ 3 mmol/L * Bilirubin normal * ALT and AST ≤ 2.5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years * No QTc prolongation (defined as a QTc interval ≥ 500 msec) or other significant ECG abnormalities * No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * No prior or concurrent NYHA class II-IV cardiovascular disease * No inadequately controlled hypertension (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) * No myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months * No pulmonary embolism within the past 12 months * No cerebrovascular accident or transient ischemic attack within the past 12 months * No serious illness or medical condition that would preclude study compliance including, but not limited to, the following: * History of significant neurologic or psychiatric disorder * Active uncontrolled infection * Serious or nonhealing wound, ulcer, or bone fracture * No medical condition that could interfere with oral medication intake (e.g., frequent vomiting, malabsorption) * No history of allergic reactions attributed to compounds with similar chemical composition to sunitinib malate * No preexisting hypothyroidism unless patient is euthyroid on medication PRIOR CONCURRENT THERAPY: * At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following: * Azole antifungals (ketoconazole, miconazole) * Verapamil * Clarithromycin * HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir) * Erythromycin * Delavirdine * Diltiazem * At least 12 days since prior and no concurrent CYP3A4 inducers, including the following: * Rifampin * Phenytoin * Rifabutin * Hypericum perforatum (St. John's wort) * Carbamazepine * Efavirenz * Pentobarbital * Tipranavir * Phenobarbital * No prior protein tyrosine kinase inhibitor * No prior antiangiogenic agent * No prior hormonal therapy, radiotherapy, chemotherapy, surgery, investigational therapy, or other therapy for breast cancer * At least 12 days since prior and no concurrent cyclooxygenase-2 inhibitors (e.g., etoricoxib, valdecoxib, celecoxib, dual cyclooxygenase/lipid oxidation, and lumiracoxib) * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide) * No other concurrent treatment for breast cancer * No concurrent coumadin-derivative anticoagulants (e.g., warfarin) * Anticoagulants at ≤ 2 mg/day for prophylaxis of thrombosis allowed * Low molecular weight heparin allowed provided INR ≤ 1.5

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (2)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Sunitinib; Immunohistochemistry; Biopsy, Needle; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Combined Modality Therapy; Therapeutics

Study Officials

• Maureen E. Trudeau, BSc, MA, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: April 8, 2009
• Primary Completion: March 15, 2010
• Study Completion: January 18, 2011
• Last Updated: February 12, 2024

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)