Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Metastatic Breast Cancer
This phase II trial studies how well giving pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation together works in treating patients with human epidermal growth factor receptor (HER)2-positive metastatic breast cancer. Monoclonal antibodies, such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel albumin-stabilized nanoparticle formulation may be a better way to block tumor growth
HER2-positive Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Prospective Open Label Single Arm Study of Pertuzumab, Trastuzumab, and Nab-Paclitaxel in Patients With HER-2 Positive Metastatic Breast Cancer|
- Progression free survival [ Time Frame: Time from initiation of treatment until objective disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]Estimated by the Kaplan-Meier method.
- Response rate (complete response [CR] + partial response [PR]) based on the RECIST version 1.1 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Estimated with 95% confidence intervals.
- Overall survival [ Time Frame: From the initial date of treatment to the recorded date of death, assessed up to 5 years ] [ Designated as safety issue: No ]Estimated by the Kaplan-Meier method. Corresponding survival times with 90% confidence limits will be determined.
- Number of patients experiencing serious adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]Characterized by type of AE and grade, and by the time of onset in relation to the first day of therapy for each course. Attribution to SAEs to treatment (unrelated, unlikely, possible, probable, or definite) will also be reported. The cumulative percentage of patients experiencing treatment related SAEs and its relationship to treatment duration will be reported.
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pertuzumab, trastuzumab, nab-paclitaxel)
Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Biological: trastuzumab
Other Names:Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other Names:Other: laboratory biomarker analysis
Optional correlative studies
I. To determine the preliminary efficacy of administration of pertuzumab in combination with trastuzumab with nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in subjects with stage IV HER-2 overexpressing breast cancer as measured by progression free survival (PFS).
I. To evaluate the safety of pertuzumab when added to trastuzumab and abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in stage IV HER-2 overexpressing breast cancer assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, and vital signs.
II. To evaluate the objective response rate and duration of response.
III. To evaluate the objective tumor response (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 criteria) where possible.
IV. To assess the overall survival.
V. To perform exploratory protein and glycomic biomarker profiling.
VI. To perform exploratory micro ribonucleic acid (RNA) and exosome profiling.
Patients receive pertuzumab intravenously (IV) over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 4 years and then every 6 months for 1 year.
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: George Somlo, MD 800-826-4673 firstname.lastname@example.org|
|Principal Investigator: George Somlo|
|City of Hope- South Pasadena Cancer Center||Recruiting|
|South Pasadena, California, United States, 91030|
|Contact: Stephen C. Koehler, MD 800-826-4673 email@example.com|
|Principal Investigator: Stephen C. Koehler|
|Principal Investigator:||George Somlo, MD||City of Hope Medical Center|