Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)

Eligibility


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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anastasia L Harper
650-725-0378
Recruiting