To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.
Cyclophosphamide will be administered per dose and schedule specified in the arm description.
Trastuzumab will be administered per dose and schedule specified in the arm description.
Teva Investigational Site 16
Kufstein, Austria
Teva Investigational Site 15
Vienna, Austria
Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast
The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue .
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines
CR: Disappearance of the lesions and no new lesions. In case of bone metastasis a CR is represented by the normalization of radiography or the complete sclerotic healing of lytic area. PR: In the case of bidimensionally measurable lesions/tumors, a decrease by at least 50% of the sum of the products of the largest perpendicular diameters of each individual lesion/tumor. In the case of unidimensionally measurable lesions a decrease by at least 50% in the largest linear tumour measurement. In the case of non-measurable but evaluable lesions an appreciable change of lesions referable to disease improvement. For bone lesions partial decrease in size or recalcification of lytic areas. No lesion should have progressed and no new lesion should appear.
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF)
Occurrence of Class III or IV (NYHA) CHF has been reported. Class III: Participants with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: Baseline up to the end of Cycle 8 (each cycle length = 21 days)
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
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Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.
Docetaxel will be administered per dose and schedule specified in the arm description.
Teva Investigational Site 9
Brussels, Belgium
Teva Investigational Site 29
Yvoir, Belgium
Teva Investigational Site 4
Clichy, France
Teva Investigational Site 5
Nancy, France
Teva Investigational Site 33
Reims, France
Teva Investigational Site 8
Vandœuvre-lès-Nancy, France
Teva Investigational Site 30
Aachen, Germany
Teva Investigational Site 11
Düsseldorf, Germany
...and 12 more locations
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). LVEF was measured using multigated acquisition (MUGA) or echocardiography.
Time frame: Baseline, up to 5 years
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. The TEAE was an AE that began or worsened after treatment with study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time frame: Baseline up to the end of Cycle 8 (cycle length = 21 days)
Percentage of Participants With Progression or Death
Progression was defined as a 25% or more increase in the size of the lesion or appearance of new lesion. If the participant did not develop an event (disease progression or death), the participant was censored at the last known tumor assessment date (or last follow-up visit without progression documented).
Time frame: Up to 5 Years after randomization
Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node
The pCR of breast and node was based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected.
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Number of Participants Undergoing Breast Conservative Surgery
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
AEs were recorded and graded per the NCI CTCAE scale. The NCI CTCAE is a toxicity scale used to grade the severity of adverse events experienced with cancer treatment. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening or disabling; Grade 5= Death related to AE. For summaries for the toxicity grade, participants were counted once at the greatest NCI CTCAE grade.
Time frame: Up to Week 24