A phase III, randomized, multicenter, open-label, two-arm study to evaluate the pharmacokinetics, efficacy, and safety of subcutaneous administration of the fixed-dose combination of pertuzumab and trastuzumab in combination with chemotherapy in patients with HER2-positive early breast cancer.

F. Hoffmann-La Roche Ltd.0 sites500 target enrollmentMarch 15, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human epidermal growth factor receptor 2 (HER2)-positive Early Breast Cancer.
Sponsor: F. Hoffmann-La Roche Ltd.
Enrollment: 500
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 15, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- Age \>\= 18 years
•\- Ability to comply with the study protocol, in the investigator’s judgment
•\- Eastern Cooperative Oncology Group Performance Status \<\= 1
•\- Female and male patients with Stage II \- IIIC (T2\-T4, plus any N, or any T plus N1\- 3, M0\), locally advanced, inflammatory, or early\-stage, unilateral, and histologically confirmed invasive breast cancer
•\- Primary tumor \> 2 cm in diameter, or node\-positive disease
•\- HER2\-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2\-positive status will be determined based on pretreatment breast biopsy material
•\- Hormone receptor status of the primary tumor, centrally confirmed
•\- Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
•\- Availability of formalin\-fixed, paraffin\-embedded tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research
•\- Baseline left ventricular ejection fraction (LVEF) \>\= 55% measured by echocardiogram or multiple\-gated acquisition scan

•\- Stage IV breast cancer
•\- Patients with a history of invasive breast cancer
•\- Patients with a history of concurrent or previously treated non\-breast malignancies except for appropriately treated 1\) non\-melanoma skin cancer and/or 2\) in situ carcinomas, including cervix, colon, and skin
•\- Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
•\- Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
•\- Patients with high\-risk for breast cancer who have received chemo preventative drugs in the past are not allowed to enter the study
•\- Patients with multi\-centric breast cancer, unless all tumors are HER2\-positive
•\- Patients with bilateral breast cancer
•\- Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
•\- Axillary lymph node dissection prior to initiation of neoadjuvant therapy