This study will evaluate patient preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered Perjeta® and Herceptin® formulations (P+H IV) in patients with HER2-positive (HER2+) early breast cancer (EBC). The study will also evaluate patient reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life (HRQoL) outcomes
Conditions
Interventions
The investigational medicinal products (IMPs) for this study are pertuzumab and trastuzumab Fixed Dose Combination SC, Perjeta IV, and Herceptin IV.
Sponsors
F. HOFFMANN-LA ROCHE LTD
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients must meet the following criteria for study entry: 1-Disease-specific criteria: -Female or male with histologically confirmed, HER2+ inflammatory, locally advanced or early stage breast cancer who have received neoadjuvant Perjeta + Herceptin and have completed neoadjuvant chemotherapy and subsequently undergone surgery for their breast cancer. -HER2+ breast cancer assessed at the local laboratory prior to initiation of neoadjuvant therapy. HER2+ status must be determined based on breast biopsy material obtained prior to neoadjuvant treatment and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of = 2 for the number of HER2 gene copies to the number of chromosome 17 copies -Hormone receptor status of the primary tumour determined by local assessment. Hormone receptor-positive status may be either positive (i.e. ER-positive and/or PgR-positive) or negative (i.e. ER-negative and PgR-negative) -Completed all neoadjuvant chemotherapy and surgery. Adjuvant radiotherapy may be planned or ongoing at study entry and adjuvant hormone therapy is allowed during the study. Note that study treatment cannot be initiated within < 2 weeks of surgery but must be initiated = 9 weeks from the last administration of systemic neoadjuvant therapy. -No evidence of residual, locally recurrent or metastatic disease after completion of surgery. Patients with clinical suspicion of metastases must undergo radiological assessments per institutional practice to rule out distant disease. -Wound healing after breast cancer surgery adequate per investigator’s assessment to allow initiation of study treatment within = 9 weeks of last systemic neoadjuvant therapy -No adjuvant chemotherapy planned. Note that adjuvant hormonal treatment is allowed during the study. 2- General criteria: ? Signed Informed Consent Form ? Age = 18 years at time of signing Informed Consent Form ? Ability to comply with the study protocol, in the investigator’s judgment ? Eastern Cooperative Oncology Group performance status 0 or 1 ? Intact skin at planned site of subcutaneous (SC) injections (thigh) ? LVEF = 55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) within 28 days of study randomization ? No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment ? For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs. ? For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom,and agreement to refrain from donating sperm. ? A negative serum pregnancy test must be available prior to randomization for women of childbearing potential (defined as post-menarchal, has not had = 12 continuous months of amenorrhea with no identified cause other than menopause, and has not undergone surgical sterilization [removal of ovaries and/or uterus]) There is no age limited mentioned in inclusion exclusion and it is added in the Age maximum as it is a mandatory field, and as advised by MOH representative
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry: 1-Cancer-specific criteria: ? Stage IV (metastatic) breast cancer ? Current or prior history of active malignancy (other than current breast cancer) within the last five years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last five years are allowed. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than five years. ? Previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy [selective oestrogen receptor modulators, aromatase inhibitors], and antitumor vaccines) for treatment or prevention of breast cancer, except neoadjuvant Perjeta, Herceptin and chemotherapy for current breast cancer 2-General criteria: ? Investigational treatment within four weeks of enrolment ? Serious cardiac illness or medical conditions including, but not confined to, the following: - History of NCI CTCAE v4.0 Grade = 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class = II - High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate = 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second-degree AV-block Type 2 [Mobitz II] or third-degree AV-block) - Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication - Angina pectoris requiring anti-angina medication - Clinically significant valvular heart disease - Evidence of transmural infarction on electrocardiogram (ECG) - Evidence of myocardial infarction within 12 months prior to randomization - Poorly controlled hypertension (e.g., systolic > 180 mmHg or diastolic > 100 mmHg) ? History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalaemia, hypomagnesemia, hypocalcaemia), or family history of sudden unexplained death or long QT syndrome ? Inadequate bone marrow function, defined by any of: - Absolute neutrophil count 1.25 x upper limit of normal (ULN). In case of Gilbert’s syndrome: a total bilirubin of 2 x ULN is permitted. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.25 x ULN - Albumin 1.5 x ULN ? Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders) ? Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within seven days prior to initiation of study treatment ? Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes t
Outcome results
None listed