NCT04395508

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

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

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2020-05-20
• Last updated: 2022-07-05

Locations

12 sites across 1 country: United States