None listed
Conditions
Interventions
- Arm A (Perjeta IV and Herceptin IV)
- Arm B (FDC of pertuzumab and trastuzumab for SC administration) Type of group
- Arm A (Perjeta IV and Herceptin IV): 8 cycles of neoadjuvant chemotherapy. This will include 4 cycles of ddAC every 2 weeks (given with granulocyte colony-stimulating factor as needed) followed by paclitaxel Q1W for 12 weeks or 4 cycles of doxorubicin plus cyclophosphamide (AC) Q3W followed by docetaxel Q3W for 4 cycles. Perjeta and Herceptin will be given IV for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, patients will und
Sponsors
F. Hoffmann- La Roche, Ltd /Genentech Inc,
Eligibility
Inclusion criteria
Inclusion criteria: •Signed Informed Consent Form •Age 18 years •Female and male patients with Stage II IIIC (T2T4, N0N3, 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.
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Take the blood sample for pharmacokinetic analysis of the serum concentrations of pertuzumab before the dose of Cycle 8. 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. Timepoints:Throughout 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Take the blood sample for pharmacokinetic analysis of the serum concentrations of trastuzumab before the dose of Cycle 8. 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. Timepoints:Throughout 12 weeks. | — |
Countries
Argentina, Belgium, Brazil, Canada, Czech Republic, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactLuisa Garcia
ROCHE FARMA (PERU) S.A.
Outcome results
None listed