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An Expanded Access 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

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ClinicalTrials.gov Identifier: NCT04395508
Expanded Access Status : Available
First Posted : May 20, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.


Condition or disease Intervention/treatment
HER2-positive Breast Cancer Drug: Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • 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 Names:
    • Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
    • PHESGO™
    • RO7198574
    • RG6264

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <50 mL/min using the Cockroft-Gault formula
  • Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
  • Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in, and completion of, the study
  • Known active liver disease, for example, active viral hepatitis infection (i.e., hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis
  • Concurrent, serious, uncontrolled infections, or known infection with human immunodeficiency virus (HIV)
  • Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Previously experienced severe injection related reactions with P+H IV, PH FDC SC, and/or trastuzumab SC
  • Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent excluding inhaled steroids)

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): NCT04395508


Contacts
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Contact: 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

Locations
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United States, California
Beverly Hills Cancer Center Available
Beverly Hills, California, United States, 90211
UCSF Helen Diller Family CCC Available
San Francisco, California, United States, 94158
Stanford Univ School of Med; Oncology Available
Stanford, California, United States, 94305-5821
United States, Colorado
University Of Colorado Available
Aurora, Colorado, United States, 80045
United States, District of Columbia
MedStar Washington Hosp Center Available
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic-Jacksonville Available
Jacksonville, Florida, United States, 32224
United States, Maryland
University of Maryland School of Medicine Available
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute Available
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Hospital-Rochester, St. Marys Campus - PPDS Available
Minneapolis, Minnesota, United States, 55455
United States, New York
Memorial Sloan Kettering Cancer Center Available
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Available
Charlotte, North Carolina, United States, 28204
United States, Washington
University of Washington Seattle Cancer Care Alliance Available
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04395508    
Other Study ID Numbers: AL42478
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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COVID-19
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents