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: Recruiting
Phase:
Diagnosis: Breast: Metastatic
NCT ID: NCT01565083
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-242
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 Day 1 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 (Cohort 1) or together in one infusion bag (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2 iv on Days 1 and 8 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 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.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Harold Burstein, MD, PhD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Eligibility Criteria
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