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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04395508|
Expanded Access Status : Available
First Posted : May 20, 2020
Last Update Posted : July 7, 2020
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 PH FDC SC is approved by the FDA and is commercially available and the COVID-19 pandemic is no longer a risk for this patient population.
|Condition or disease||Intervention/treatment|
|HER2-positive Breast Cancer||Drug: Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC)|
|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|
- 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 Names:
- Pertuzumab, Trastuzumab, and Hyaluronidase-ZZXF
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
|Contact: Reference Study ID Number: AL42478 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. only)||email@example.com|
|United States, District of Columbia|
|MedStar Washington Hosp Center||Available|
|Washington, District of Columbia, United States, 20010|
|Study Director:||Clinical Trials||Genentech, Inc.|