HER2-positive early breast cancer MedDRA version: 16.0 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
Interventions
Product Name: Trastuzumab sc
Product Code: RO452317
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Current Sponsor code: Ro 45-2317/F07
Concentrat
Sponsors
Roche Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged = 18 years 2. Signed informed consent prior to any study specific procedure 3. Able and willing to comply with protocol 4. Eastern Cooperative Oncology Group (ECOG) performance status 0–1 5. Hormonal therapy will be allowed as per institutional guidelines 6. Patients must be trastuzumab naïve 7. Left ventricular ejection fraction (LVEF) of = 55% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrolment 8. HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 9. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast 10. No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) 11. Use of concurrent curative radiotherapy will be permitted 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 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible 2. Patients with severe dyspnea at rest or requiring supplementary oxygen therapy 3. Patients with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness 4. Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension 5. Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days prior to the first dose of study drug 6. Women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause (unless surgically sterile), and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment. In this study, menopause is defined as a minimum of 12 consecutive months of amenorrhea during which time no other biological or physiological cause had been identified as a potential cause of this state. Examples of adequate contraceptive measures are intrauterine device, barrier method (condoms, diaphragm) also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not acceptable 7. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment 8. Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin® including hyaluronidase, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma 9. Patients assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol 10. Inadequate bone marrow function (as indicated by any of the following): a) Absolute neutrophil count (ANC) 1.5 × upper limit of normal (ULN) b) Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) > 2.5 × ULN c) Alkaline phosphatase (ALP) > 2.5 × ULN 12. Inadequate renal function, as indicated by serum creatinine > 1.5 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Quality of Life in HER2-positive eBC patients treated with trastuzumab solution injected subcutaneously into the thigh vs upper arm ;Secondary Objective: To characterize the pharmacokinetics of trastuzumab (Ctrough, Cmax, Tmax, AUC) following subcutaneous injection at the thigh and upper arm. To determine HCP’s satisfaction of trastuzumab solution injected subcutaneously into the thigh vs upper arm To determine patient’s satisfaction and preference of injection method and of injection site of trastuzumab solution injected subcutaneously (Questionnaires at trastuzumab Cycle 10 and 14 and decision of injection site of trastuzumab injected subcutaneously after Cycle 14) To determine efficacy (overall survival and disease free survival) To determine safety and tolerability of trastuzumab solution injected subcutaneously Exposure to study medication Duration of treatment, follow-up ;Primary end point(s): Primary Endpoint 1: Ø QoL-VAS (QoL-VAS: Assessment of Quality of Life by Visual Analogue Scale: Range: 0-10; 0 = no influence on QoL by injection, 10 = worst imaginable influence on QoL by injection; Ø QoL-VAS: mean value of the QoL-VAS assessed 21 days after each injection at Cycle 7-10 or at Cycle 11-14) Primary Endpoint 2: max QoL-VAS (QoL-VAS: Assessment of Quality of Life by Visual Analogue Scale: Range: 0-10; 0 = no influence on QoL by injection, 10 = worst imaginable influence on QoL by injection; max QoL-VAS: highest value of the QoL-VAS assessed 21 days after each injection at Cycle 7-10 or at Cycle 11-14) ;Timepoint(s) of evaluation of this end point: The primary analysis will be undertaken once all patients have completed the study (treatment phase and 28-days safety follow-up visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Trastuzumab Pharmacokinetics: Ctrough, Cmax, Tmax and AUC • Efficacy-parameter: OS and DFS • Satisfaction and preference parameter: items of the Questionnaires (Cycles 10 and 14) patient’s decision of injection site after Cycle 14 HCP satisfaction • QoL parameter: QoL-VAS at Cycles 7-14 • Safety parameter: ADR; SAE, AE ;Timepoint(s) of evaluation of this end point: The primary analysis will be undertaken once all patients have completed the study (treatment phase and 28-days safety follow-up visit). | — |
Countries
Austria
Outcome results
None listed