Phase III multicenter, double-blind, randomized, parallel-group study to evaluate safety and efficacy of Hercules plus Taxane Herceptin® plus Taxane as First Line therapy in Her2-Positive Metastatic Breast cancer.
- Conditions
- Health Condition 1: null- Drug will be tested in HER and MBC patients
- Registration Number
- CTRI/2014/12/005334
- Lead Sponsor
- Mylan GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 600
Subjects must meet the following criteria to be included in the study:
1.Female/male grater and equal to 18 years of age
2. Histologically confirmed diagnosis of breast cancer
3. Locally recurrent or MBC that is not amenable to curative surgery and/or radiation
4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used. 5. Documentation of estrogen receptor/progesterone receptor (ER/PgR) status (positive or negative) based on either a local or central laboratory report must be available before randomization
6. Pathologically confirmed breast cancer with at least one measurable metastatic target lesion (based on RECIST criteria, version 1.1. Bone central nervous system and skin lesions as well as lesions that were irradiated, biopsied or had any form of local intervention or surgical manipulation are only to be assessed as non-target lesions. Baseline imaging studies of target lesions must have been performed and submitted for central confirmation in the 4 weeks preceding randomization.
7. Patients with a history of CNS metastases or cord compression are eligible if they have been successfully treated and are off steroids for at least 4 weeks before first dose of investigational product. Patients with newly detected CNS metastases must be successfully treated eg radiotherapy, stereotactic radiosurgery) before being considered for the trial. Patients with known or suspected brain metastases must undergo a baseline brain computed tomography or magnetic resonance imaging.
8. Patients previously treated with trastuzumab or lapatinib in the adjuvant setting are allowed if metastatic disease was diagnosed at least one year after the last dose of treatment.
9. Prior treatment with hormonal agents or bisphosphonates/denosumab is allowed. Bisphosphonates/denosumab can be given simultaneously with study treatment but cannot start after randomization and is considered an indication of progressive disease . Hormonal agents must be discontinued prior to beginning study therapy
10. Eastern Cooperative Oncology Group performance status of 0 - 2.
11. Screening laboratory values within the following parameters:
ANC greater than equal to1.5 x 109/L (1500/mm3), Platelet count greater than equal to100 x 109/L (100,000/mm3), Hemoglobin greater than equal to 9.0 g/dL (90 g/L) without a prior transfusion in the last 2 weeks, Serum creatinine less than equal to 1.5 x ULN (upper limit of normal), Total bilirubin less than equal to 1.0 x ULN (grater than 1.0 x ULN if documented Gilbertâ??s disease), AST and/or ALT less than equal to 2.5 x ULN, AST and/or ALT less than 1.5 x ULN if alkaline phosphatase greater than 2.5 x ULN, Alkaline phosphatase greater than 2.5 x ULN;if bone metastases
1. Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy.
2. Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, epirubicin dose greater than 800 mg/m2.
3. Participation in the active treatment phase of an investigational drug study less than equal to 8 days prior to randomization
4. Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed.
5. Surgery or radiotherapy less than equal to 2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy
6. Presence of unstable angina or a history of congestive heart failure according to the New York Heart Association criteria, history of myocardial infarction less than 1 year from randomization, clinically significant valvular disease, serious cardiac arrhythmia requiring treatment, uncontrolled hypertension or known pulmonary hypertension
7. Peripheral sensory or motor neuropathy Grade 2 or higher according to the National Cancer Institute-Common Terminology Criteria (NCI-CTC) Version 4.03.
8.Any other cancer, including contralateral breast cancer, within 5 years prior to screening with the exception of adequately treated ductal carcinoma in situ, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
9. Immunocompromized patients, including known seropositivity for human immunodeficiency virus, or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen or antibody to hepatitis C virus with confirmatory testing)
10. Patients with documented severe hypersensitivity reaction to trastuzumab, paclitaxel, docetaxel or excipients used in their formulations, including murine protein remnants
11. Evidence of significant medical illness (including dyspnea at rest or serious pulmonary illness, etc.) or abnormal laboratory finding that, in the Investigatorâ??s judgment, will substantially increase the risk associated with the patientâ??s participation in, and completion of, the study, or could preclude the evaluation of the patientâ??s response
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method