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Pertuzumab With High-Dose Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02536339
First Posted: August 31, 2015
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Pertuzumab Drug: Trastuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase II Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Central Nervous System Progression Post-Radiotherapy in Patients With HER2-Positive Metastatic Breast Cancer (PATRICIA)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Objective Response (OR) in the CNS Assessed per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria [ Time Frame: Baseline up to approximately 3 years (assessed every 6 week for first 2 scans, then every 8 weeks for subsequent 2 scans, followed by every 12 weeks until disease progression, at the treatment discontinuation visit) ]

Secondary Outcome Measures:
  • Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Points From Baseline and to Below 50 Percent (%) [ Time Frame: Baseline until death due to any cause (assessed at Week 6 and 12, followed by every 3 months during treatment period, then every 6 months up to approximately 3 years) ]
  • Duration of Response (DOR) in the CNS [ Time Frame: Baseline up to approximately 3 years (assessed every 6 week for first 2 scans, then every 8 weeks for subsequent 2 scans, followed by every 12 weeks until disease progression, at the treatment discontinuation visit) ]
  • Percentage of Participants With Clinical Benefit in the CNS as Assessed Using RANO-BM Criteria [ Time Frame: Baseline up to approximately 3 years (assessed every 6 week for first 2 scans, then every 8 weeks for subsequent 2 scans, followed by every 12 weeks until disease progression, at the treatment discontinuation visit) ]
  • Progression Free Survival - in the CNS as Assessed Using RANO-BM Criteria [ Time Frame: Baseline up to approximately 3 years (assessed every 6 week for first 2 scans, then every 8 weeks for subsequent 2 scans, followed by every 12 weeks until disease progression, at the treatment discontinuation visit) ]
  • Progression Free Survival Systemically as Assessed Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: Baseline up to approximately 3 years (assessed every 8 weeks for the first 16 weeks, then every 12 weeks until disease progression) ]
  • Overall Survival [ Time Frame: Baseline until death due to any cause (up to approximately 3 years) ]
  • Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to approximately 3 years ]
  • Serum Pertuzumab Concentrations [ Time Frame: pre-dose (0 − 4 hours) and post-infusion (0 - 30 minutes, infused over 60 minutes) on Day 1 of Week 1 and 16, pre-dose (0 − 4 hours) on Day 1 of Week 4 and Week 10 ]
  • Serum Trastuzumab Concentrations [ Time Frame: pre-dose (0 − 4 hours) and post-infusion (0 - 30 minutes, infused over 30 - 90 minutes) on Day 1 of Week 1 and 16, pre-dose (0 − 4 hours) on Day 1 of Week 4 and Week 10 ]
  • M.D. Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Assessment Score [ Time Frame: Baseline, every 6 weeks, followed by every 8 weeks, then every 12 weeks until progression (up to approximately 3 years) ]

Enrollment: 40
Actual Study Start Date: December 16, 2015
Estimated Study Completion Date: June 28, 2019
Estimated Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + Trastuzumab
Participants with CNS metastases secondary to HER2-positive MBC will receive pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Drug: Pertuzumab
Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: Perjeta
Drug: Trastuzumab
Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Name: Herceptin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed HER2-positive MBC
  • Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery
  • Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment
  • Stable systemic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • LVEF at least 50%
  • Adequate hematologic, renal, and hepatic function
  • Life expectancy more than 12 weeks

Exclusion Criteria:

  • Progression of systemic disease at Screening
  • Leptomeningeal disease
  • History of intolerance or hypersensitivity to study drug
  • Use of certain investigational therapies within 21 days prior to enrollment
  • Current anthracycline use
  • Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use
  • Active infection
  • Pregnant or lactating women
  • Significant history or risk of cardiac disease
  • Symptomatic intrinsic lung disease or lung involvement
  • History of other malignancy within the last 5 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536339


Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Stanford Cancer Institute
Stanford, California, United States, 94305-5456
United States, Florida
University of Miami Hospital & Clinics
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Medical Center; Department of Neurology
Baltimore, Maryland, United States, 21201
Associates in Oncology-Hematology, PC
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Allina Health System
Saint Paul, Minnesota, United States, 55102
United States, New York
ProHEALTH Care Associates LLP
Lake Success, New York, United States, 11042
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Ohio
Mid Ohio Oncology Hematology;ZangMeister Center (West)
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Penn State Univ. Milton S. Hershey Medical Center; Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Temple Cancer Center; Oncology
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Methodist Hospital Research Institute
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute; University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02536339     History of Changes
Other Study ID Numbers: ML29366
First Submitted: August 10, 2015
First Posted: August 31, 2015
Last Update Posted: July 19, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Trastuzumab
Antineoplastic Agents


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