Clinical Trials /

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

NCT02536339

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: ML29366
  • NCT ID: NCT02536339

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
PertuzumabPerjetaPertuzumab + Trastuzumab
TrastuzumabHerceptinPertuzumab + Trastuzumab

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.

Trial Arms

NameTypeDescriptionInterventions
Pertuzumab + TrastuzumabExperimentalParticipants 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.
  • Pertuzumab
  • Trastuzumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Baseline until death due to any cause (up to approximately 3 years)
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events and Serious Adverse Events
Time Frame:Baseline up to approximately 3 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

January 11, 2018