Treatment With Pazopanib for Neoadjuvant Breast Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Breast

In brief

The purpose of this study is to determine whether the treatment of a doxorubicin in combination with cyclophosphamide followed by a combination of pazopanib in combination with paclitaxel prior to surgery results in a pathological complete response in females with breast cancer.

Key facts

Study ID

NCT00849472

Run by

GlaxoSmithKline

People needed

101

Starts

2009-07-01

Expected to finish

2013-04-01

Last updated by the study team

2014-03-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of tumor and blood samples required for the FB-6 correlative science studies
• The ECOG performance status must be 0 or 1
• Patients must have the ability to swallow oral medication.
• The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
• Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)
• Patients must have clinical stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla measuring at least 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.
• Adequate organ function
• LVEF assessment by 2-D echocardiogram or MUGA scan performed within 3 months prior to study entry must be greater or equal to 50% regardless of the facility's LLN.
• ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.
• The TSH level must be within normal limits for the laboratory.

You may not qualify if…

• Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by FISH or CISH (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.
• FNA alone to diagnose the primary breast cancer.
• Excisional biopsy or lumpectomy performed prior to study entry.
• Surgical axillary staging procedure prior to study entry.
• Definitive clinical or radiologic evidence of metastatic disease.
• History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.
• Contralateral invasive breast cancer at any time.
• Non-breast malignancies unless the patient is considered to be disease-free for 5 or more years prior to study entry and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Requirement for chronic use of any of the prohibited medications or substances
• Previous therapy with anthracyclines, taxanes, or pazopanib for any malignancy.
• Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
• Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM.
• Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy
• History of hepatitis B or C.
• Symptomatic pancreatitis or asymptomatic greater or equal to grade 2 elevation of amylase or lipase as per NCI CTCAE v3.0.
• History of documented pancreatitis.
• Uncontrolled hypertension defined as systolic BP greater than 140 mmHg or diastolic BP greater greater than 90 mmHg, with or without anti-hypertensive medication.
• History of hypertensive crisis or hypertensive encephalopathy.
• Cardiac disease that would preclude the use of any of the drugs included in the FB-6 treatment regimen.
• History of TIA or CVA.
• History of any arterial thrombotic event within 12 months prior to study entry.
• Pulmonary embolism or DVT within 6 months prior to study entry.
• Symptomatic peripheral vascular disease.
• Any significant bleeding within 6 months prior to study entry, exclusive of menorrhagia in premenopausal women.
• Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.

Where it is running

• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Antioch, California, United States
• GSK Investigational Site — Fremont, California, United States
• GSK Investigational Site — Hayward, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Redwood City, California, United States
• GSK Investigational Site — Richmond, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — San Rafael, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Santa Rosa, California, United States
• GSK Investigational Site — South San Francisco, California, United States
• GSK Investigational Site — Stockton, California, United States
• GSK Investigational Site — Vacaville, California, United States
• GSK Investigational Site — Vallejo, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Decatur, Alabama, United States

Full record on ClinicalTrials.gov

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