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 OFPERTUZUMAB AND TRASTUZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-012-18
- Lead Sponsor
- F. Hoffmann- La Roche, Ltd /Genentech Inc,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
•Signed Informed Consent Form
•Age 18 years
•Female and male patients with Stage II IIIC (T2T4, N0N3, M0), locally advanced,
inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
Patients with inflammatory breast cancer must be able to have a core-needle biopsy
•Primary tumor 2 cm in diameter, or node-positive (clinically, on imaging, and on
cytology/histopathology)
•HER2-positive breast cancer confirmed by a central
•Hormone receptor status of the primary tumor confirmed
•Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant
therapy
•Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central
confirmation of HER2 and hormone receptor status and additional biomarker research (e.g.,
PIK3A mutational analyses)
•Baseline LVEF 55% measured by echocardiogram (ECHO) or multiple-gated acquisition
scan (MUGA)
•For women of childbearing potential (WOCBP) who are sexually active: agreement to
remain abstinent (refrain from heterosexual intercourse) or use one highly effective nonhormonal
contraceptive method.
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use one highly effective nonhormonal contraceptive method, and agreement to refrain from donating sperm.
•A negative serum pregnancy test must be available prior to randomization.
•Stage IV (metastatic) 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 (including chemotherapy,
immunotherapy, HER2-targeted agents, endocrine therapy (selective estrogen receptor
modulators, aromatase inhibitors, and antitumor vaccines) 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 (DCIS) or lobular carcinoma in
situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy
to the ipsilateral breast
Patients are allowed to enter the study if treated with surgery alone.
•Patients with high-risk for breast cancer who have received chemopreventative drugs in the
past are not allowed to enter the study
•Patients with multicentric (multiple tumors involving more than one quadrant) 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 (ALND) prior to initiation of neoadjuvant therapy
Patients with clinically negative axilla (by physical examination and radiographic
imaging) may undergo a core or needle biopsy procedure prior to neoadjuvant systemic
therapy if in keeping with local practice
•Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
•Treatment with any investigational drug within 28 days prior to randomization
•Serious cardiac illness or medical conditions
•Inadequate bone marrow function
•Impaired liver function
•Inadequate renal function with serum creatinine 1.5 ULN
For more details consult the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Take the blood sample for pharmacokinetic analysis of the serum concentrations of pertuzumab before the dose of Cycle 8.<br>Measure:Serum pertuzumab Ctrough during Cycle 7 (pre-dose Cycle 8) from pertuzumab SC within the FDC to the Perjeta IV formulation in patients with HER2-positive EBC.<br>Timepoints:Throughout 12 weeks.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Take the blood sample for pharmacokinetic analysis of the serum concentrations of trastuzumab before the dose of Cycle 8.<br>Measure:Serum trastuzumab Ctrough during Cycle 7 (pre-dose Cycle 8) from trastuzumab SC within the FDC to the Herceptin IV formulation in patients with HER2-positive EBC.<br>Timepoints:Throughout 12 weeks.<br>