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 fixed-dose combination of pertuzumab and trastuzumab 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 are currently receiving pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV). The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 400 participants with HER2+ breast cancer who have completed concurrent chemotherapy with P+H IV and are currently receiving or will be receiving maintenance therapy with pertuzumab and trastuzumab. 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 they received prior to enrolling in this study. 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: Fixed-Dose Combination of Pertuzumab and Trastuzumab 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 or PH FDC SC treatment must receive a loading dose before continuing with maintenance doses for subsequent administrations.
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 Perjeta and Herceptin and are currently receiving maintenance P+H IV (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:

- Investigational treatment within 4 weeks of enrollment

- 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

- 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 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

UCSF Helen Diller Family CCC
San Francisco, California, 94158

Available

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

Available

MedStar Washington Hosp Center
Washington, District of Columbia, 20010

Available

University of Maryland School of Medicine
Baltimore, Maryland, 21201

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