Official Title
An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic
Brief Summary

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study. A remote cardiac surveillance substudy will be optional for patients enrolled at the Mayo Clinic (select sites) and Memorial Sloan Kettering Cancer Center (MSKCC) sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

Available
Treatment IND/Protocol
HER2-positive Breast Cancer

Drug: Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
PH FDC SC is given as a fixed dose (i.e. non-weight based) subcutaneous injection. Two dosage configurations of PH FDC SC may be administered in the study: a 15-millilitre (mL) loading dose consisting of 1200 milligrams (mg) pertuzumab and 600 mg trastuzumab and a 10-mL maintenance dose consisting of 600 mg pertuzumab and 600 mg trastuzumab. Participants who have had ≥6 weeks since their last P+H IV, PH FDC SC, or are receiving trastuzumab SC treatment must receive a loading dose before continuing with maintenance doses for subsequent administrations. Note that participants receiving trastuzumab SC only (i.e. without pertuzumab) must receive a loading dose regardless of time since last treatment.
Other Name: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Other Name: PHESGO™
Other Name: RO7198574
Other Name: RG6264

Eligibility Criteria

Inclusion Criteria: - Female or male patients with histologically confirmed human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed chemotherapy in combination with P+H IV and are currently receiving or will be receiving maintenance P+H IV, PH FDC SC, or trastuzumab SC (regardless of remaining treatment cycles [e.g., only 1 cycle remaining]) - HER2+ status must have been previously determined and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥2 for the number of HER2 gene copies to the number of chromosome 17 copies - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Intact skin at planned site of subcutaneous (SC) injections (thigh) - Baseline and most recent (within 3 months) LVEF ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined in the protocol - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined in the protocol

Exclusion Criteria: - Current or prior history of active malignancy (other than current breast cancer) within the last 5 years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last 5 years are allowed - Investigational treatment within 4 weeks of enrollment - Patients with any severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection). Patients with suspected or confirmed COVID-19 may be re-screened for eligibility following physician-prescribed COVID-19 treatment and/or quarantine and following a negative COVID-19 real-time reverse transcription polymerase chain reaction (rRT-PCR) test - Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their INR - Serious cardiac illness or medical conditions - History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome - Inadequate bone marrow function - Impaired liver function - Renal function with creatinine clearance 10 mg methylprednisolone or equivalent excluding inhaled steroids)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Beverly Hills Cancer Center
Beverly Hills, California, 90211

Available

UCSF Helen Diller Family CCC
San Francisco, California, 94158

Available

Stanford Univ School of Med; Oncology
Stanford, California, 94305-5821

Available

University Of Colorado
Aurora, Colorado, 80045

Available

MedStar Washington Hosp Center
Washington, District of Columbia, 20010

Available

Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224

Available

University of Maryland School of Medicine
Baltimore, Maryland, 21201

Available

Dana Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Mayo Clinic Hospital-Rochester, St. Marys Campus - PPDS
Minneapolis, Minnesota, 55455

Available

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Available

Levine Cancer Institute
Charlotte, North Carolina, 28204

Available

University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195

Available

Contacts

Reference Study ID Number: AL42478 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. only)
global-roche-genentech-trials@gene.com

Clinical Trials
Study Director
Genentech, Inc.

Genentech, Inc.
NCT Number
MeSH Terms
Breast Neoplasms
Trastuzumab
Pertuzumab
Intervention Name
Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)