HER2-POSITIVE METASTATIC OR LOCALLY RECURRENT ADVANCED BREAST CANCER MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection. Patients with measurable and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible. - HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor or metastatic site if primary tumor not available - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Left ventricular ejection fraction (LVEF) of at least 50% - Negative serum pregnancy test result at baseline and use of effective contraception as defined by the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 336 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for metastatic or locally recurrent disease are permitted, one of which may be in combination with everolimus. - Disease-free interval of less than 6 months from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of breast cancer - Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy for any breast cancer treatment, except Herceptin - History of persistent Grade 2 or higher hematological toxicity resulting from previous adjuvant or neoadjuvant therapy - Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment - Current peripheral neuropathy of Grade 3 or greater - History of other malignancy within the last 5 years prior to first dose of study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma - Inadequate organ function - Uncontrolled hypertension with or without medication - Clinically significant cardiovascular disease - History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or adjuvant therapy - Current known infection with HIV, hepatitis B virus, or hepatitis C virus - Severe uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications, including severe pulmonary conditions/illness - Pregnant or lactating women - Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy - History of receiving any investigational treatment within 28 days prior to first dose of study drug administration (dosing) or concurrent participation in any interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in patients with HER2-positive advanced (metastatic or locally recurrent) breast cancer. • Overall safety profile as determined by adverse events of any grade of severity, and adverse events Grade = 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 and cardiac function will be assessed including the following: cardiac events Grade = 3, congestive heart failure (CHF), and cardiac death;Secondary Objective: The secondary objectives for this study are to evaluate Herceptin SC in combination with Perjeta IV plus docetaxel with respect to: • Efficacy parameters PFS OS Objective Response Rate (ORR) • Incidence of anti-Herceptin and anti-rHuPH20 antibody formation;Primary end point(s): - Incidence and severity of adverse events Grade >/= 3, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 - Incidence of cardiac events (composite outcome measure): congestive heart failure (CHF) and cardiac death - Incidence of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years - Timeframe: Up to 24 months after the last patient has been enrolled, approximately 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival, tumor assessments according to RECIST v1.1 - Overall survival - Objective response rate, defined as a complete response (CR) or a partial response (PR) - Outcome Measure: Incidence of anti-Herceptin, anti-rHuPH20 antibodies ;Timepoint(s) of evaluation of this end point: - Timeframe: Up to 3.5 years - Timeframe: Up to 3.5 years - Timeframe: Up to 3.5 years - Timeframe: Up to 3.5 years | — |
Countries
Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed