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A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
Not Recruiting
Trial ID: NCT01565083
Purpose
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy
of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line
participants with metastatic or locally advanced HER2-positive breast cancer. Participants
will receive pertuzumab and trastuzumab administered sequentially as separate intravenous
(IV) infusions (followed by vinorelbine) and conventional sequential administration of
pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.
Official Title
A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer
Stanford Investigator(s)
Mark Pegram
Susy Yuan-Huey Hung Professor
Allison W. Kurian, M.D., M.Sc.
Professor of Medicine (Oncology) and of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed and documented adenocarcinoma of the breast
with metastatic or locally advanced disease not amenable to curative resection
- HER2-positive as assessed by local laboratory on primary or metastatic tumor
- At least one measurable lesion and/or non-measurable disease evaluable according to
RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Left ventricular ejection fraction (LVEF) of at least 55%
- Life expectancy of at least 12 weeks
Exclusion Criteria:
- Previous systemic non-hormonal anti-cancer therapy in the metastatic or locally
advanced breast cancer setting
- Previous approved or investigative anti-HER2 agents in any breast cancer treatment
setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
- Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or
neoadjuvant setting
- Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal
treatment to recurrent disease of less than 6 months
- History of persistent Grade 2 or higher (National Cancer Institute Common Terminology
Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous
adjuvant or neoadjuvant therapy
- Radiographic evidence of central nervous system metastases that are not well
controlled with local therapy (irradiation or surgery)
- Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
- History of other malignancy within the last 5 years, except for carcinoma in situ of
the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a
similar curative outcome as those mentioned above
- Serious uncontrolled concomitant disease that would contraindicate the use of any of
the investigational drugs used in this study or would put the participants at high
risk for treatment-related complications
- Inadequate hematologic, liver, or renal function
- Uncontrolled hypertension or clinically significant cardiovascular disease
- Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
- Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone
or equivalent), excluding inhaled steroids
Intervention(s):
drug: Trastuzumab
drug: pertuzumab
drug: vinorelbine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061