HER2-positive Breast CancerNCT04395508
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
A study testing Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC) in people with HER2-positive Breast Cancer, run by Genentech, Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 a quarantine period consistent with current Centers for Disease Control and Prevention (CDC) guidelines.
- 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
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- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University Of Colorado
Aurora, Colorado, 80045
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Levine Cancer Institute
Charlotte, North Carolina, 28204
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Hospital-Rochester, St. Marys Campus - PPDS
Minneapolis, Minnesota, 55455
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
UCSF Helen Diller Family CCC
San Francisco, California, 94158
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
Stanford Univ School of Med; Oncology
Stanford, California, 94305-5821
MedStar Washington Hosp Center
Washington D.C., District of Columbia, 20010
About this study
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
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.
Read more
Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation.
A remote cardiac surveillance substudy will be optional for patients enrolled at select sites.
The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)Drug
Also called Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, PHESGO®, RO7198574, RG6264
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395508
- Sponsor's protocol ID
- AL42478
- Status last verified
- Jun 2022
- First submitted
- 15 May 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04395508
- Acronym / sponsor ID
- AL42478
- Conditions
- HER2-positive Breast Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation.
A remote cardiac surveillance substudy will be optional for patients enrolled at select sites.
The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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 a quarantine period consistent with current Centers for Disease Control and Prevention (CDC) guidelines.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)Also: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, PHESGO®, RO7198574, RG6264PH 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC) in people with HER2-positive Breast Cancer, run by Genentech, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.