A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer

Status:	Completed
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	April 2012
End Date:	October 2015

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.

This two-cohort, open-label, multicenter, phase II study will assess the safety and efficacy
of pertuzumab given in combination with Herceptin (trastuzumab) and vinorelbine in first
line in patients with metastatic or locally advanced HER2-positive breast cancer. Patients
will receive pertuzumab 840 mg and Herceptin 8 mg/kg administered sequentially as separate
iv infusions on Days 1 and 2, respectively, of Cycle 1. From Cycle 2 onwards, patients will
receive pertuzumab 420 mg and Herceptin 6 mg/kg, administered either sequentially as
separate iv infusions on Day 1 and Day 1 or 2, respectively (Cohort 1) or together in one
infusion bag on Day 1 (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2
iv on Days 2 and 9 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 (or Days 2 and 9) of each
following 3-week cycle. Anticipated time on study treatment is until disease progression or
unacceptable toxicity occurs, or withdrawal of consent or death.

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed 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 version 1.1 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 anticancer therapy in the metastatic or locally
advanced 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 (NCI-CTC Version 4.0) hematological toxicity
resulting from previous adjuvant or neoadjuvant therapy

- Radiographic evidence of central nervous system (CNS) metastases

- Current peripheral neuropathy of Grade 3 or greater

- History of other malignancy within the last 5 years, except for carcinoma in situ of
the cervix or basal cell carcinoma

- Serious uncontrolled concomitant disease that would contraindicate the use of any of
the investigational drugs used in this study or would put the patients 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 HIV infection

- Current chronic daily treatment with corticosteroids (>/= 10 mg/day
methylprednisolone or equivalent), excluding inhaled steroids

We found this trial at

sites

Clinical Trial Facility in Plantation Florida

Plantation, Florida 33317

from

Plantation, FL