Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche


  • Drug: Pertuzumab
  • Drug: Trastuzumab
  • Drug: Vinorelbine


Phase 2


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting