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

Cancer
Breast Cancer
Metastatic Breast Cancer

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT02536339, ML29366

Condition Metastatic Breast Cancer

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)

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS ML29366 PATRICIA Final Results March 2021 English (PDF, 1.8 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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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

For the latest version of this information please go to www.forpatients.roche.com