Featured Clinical Trial:

Untreated Her2-positive metastatic breast cancer (product/compound: Pertuzumab)

ClinicAid Locations: Southern California – Fountain Valley

Status: Enrollment closed.

Condition: Untreated Her2-Positive Metastatic Breast Cancer

Product Name/Compound: Pertuzumab

Full Study Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer

Eligible Participants:

Inclusion (Eligible):

Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Patients with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; patients with de-novo Stage IV disease are eligible)
HER2-positive metastatic breast cancer (MBC)
Age ≥ 18 years
Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline (within 42 days of randomization)

Exclusion (Not Eligible):

History of anticancer therapy for MBC (with the exception of one prior hormonal regimen for MBC)
History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting
History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months
History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
Current clinical or radiographic evidence of central nervous system (CNS) metastases
History of exposure to cumulative doses of anthracyclines
Current uncontrolled hypertension or unstable angina
History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment
History of myocardial infarction within 6 months of randomization
Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
Current known infection with HIV, HBV, or HCV
Current chronic daily treatment with corticosteroids (excluding inhaled steroids)

Study Phase: Phase III (What are Phases?)

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Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT00567190

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