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A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study to Compare the Efficacy and Safety of Hercules Versus Herceptin® in Patients with HER2+Metastatic Breast Cancer

PHRR130220-000051

2014-CT0228

2014-CT0228

A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study of the Efficacy and Safety of Hercules plus Taxane versus Herceptin® plus Taxane as First Line Therapy in Patients with HER2-Positive Metastatic Breast Cancer

A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study to Compare the Efficacy and Safety of Hercules Versus Herceptin® in Patients with HER2+Metastatic Breast Cancer. Primary objective is to compare the effect of Hercules vs. Herceptin on the over-all tumor response, both in combination with docetaxel, in patients with HER2+ metastatic breast cancer. Secondary: - To compare the effect of Hercules and Herceptin®, both in combination with docetaxel, on the following relevant parameters: -time to tumor progression; -progression-free survival; -duration of response; -overall survival; -To compare the safety, immunogenicity and tolerability profile of Hercules and Herceptin® given in combination with docetaxel (study Part 1); - To compare the safety, immunogenicity and efficacy of Hercules and Herceptin® given as monotherapy (study Part 2). - To compare the pharmacokinetic (PK) profile of Hercules and Herceptin® using a population pharmacokinetic (PopPK) approach (study Part 1). Exploratory: -To assess the impact of shed extracellular domain fragments of the HER2 receptor (HER2/ECD) in serum on various parameters.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2012-11-16 60 2017-11-16 0000-00-00

Ongoing

Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Amount Region
MYLAN GmbH N/A Switzerland
Name E-Mail Phone Number Postal Address
Ma. Veron P. Migo veron.migo@incresearch.com +63 2 464 7007 Unit 2903/4 29th Flr., Discovery Centre, #25 ADB Ave., Ortigas Center, Pasig City 1605, Philippines
Name E-Mail Phone Number Postal Address
Ma. Veron P. Migo veron.migo@incresearch.com +63 2 464 7007 Unit 2903/4 29th Flr., Discovery Centre, #25 ADB Ave., Ortigas Center, Pasig City 1605, Philippines
Name Expertise Affiliation
Maria Belen E. Tamayo, MD Oncology Makati Medical Center
Felycette Gay Martinez-Lapus, MD Oncology Davao Doctors Hospital
Priscilla B. Caguioa, MD Oncology St. Luke's Medical Center - Quezon City
Ma. Noemi Alsay-Uy, MD Oncology Cebu Doctors' University Hospital
Ma. Luisa Abesamis-Tiambeng, MD Oncology Cardinal Santos Medical Center
Beatrice J. Tiangco, MD Oncology National Kidney and Transplant Institute
Joseph Parra, MD Oncology St. Luke's Medical Center - Global City
Marie Cherry Lynn Samson-Fernando, MD Oncology Manila Doctors Hospital
Ellie May Villegas, MD Oncology Perpetual Succour Hospital
Paul Dexter Santos, MD Oncology De La Salle Health Sciences Institute
Project Location Institutional Ethics Review Board
Makati Medical Center Makati Medical Center Institutional Review Board
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Cardinal Santos Medical Center Cardinal Santos Medical Center Ethics Review Committee
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Luke's Medical Center - Global City N/A
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee

Breast Cancer

To compare the effect of Hercules and Herceptin® in combination with docetaxel on the overall tumor response, in patients with HER2+ metastatic breast cancer.

To compare the effect of Hercules and Herceptin®, both in combination with docetaxel on the following relevant parameters: o time to tumor progression; o progression-free survival; o duration of response; o overall survival.  To compare the safety and tolerability profile of Hercules and Herceptin® when given in combination with docetaxel (study Part 1);  To compare the safety and efficacy of Hercules or Herceptin ® when given as monotherapy (study Part 2);  To compare the PK profile of Hercules and Herceptin® using a PopPK approach (study Part 1).

Completed

  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Czech Republic
  • Egypt
  • Georgia
  • Germany
  • Hungary
  • India
  • Morocco
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia and Montenegro
  • Slovakia
  • South Africa
  • Thailand
  • Tunisia
  • Turkey
  • Ukraine

Clinical Trial

Unspecified

2014-09-11

None

Inclusion criteria: 1. Female ≥ 18 years of age. 2. Pathologically confirmed, uni-dimensionally measurable MBC lesion (based on Response Evaluation Criteria in Solid Tumor [RECIST] criteria, version 1.1). Measurable lesion is defined as a visceral lesion at least 10 mm in longest diameter or lymph node at least 15 mm in short axis. Bone, central nervous system (CNS), 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 in the 4 weeks preceding randomization. 3. HER2 over-expression assessed centrally by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) using tumor tissue from a metastatic lesion or (archival) tissue from the primary tumor of the breast or lymph nodes. Patients with an IHC score 3 are eligible. Patients with an IHC score 2, must also have a positive FISH. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) <2. 5. Life expectancy of at least 6 months. 6. The patient is willing to comply with the protocol and procedures for the duration of the study, including all scheduled visits and examinations. 7. The patient is either not of childbearing potential or is willing to practice birth control or abstain from sexual intercourse for the duration of the study and follow-up. In particular, patients of childbearing potential must: a. Use an intra-uterine device, diaphragm with spermicide or condom with spermicide, and b. Have a negative serum (on Screening) or urinary human chorionic gonadotropin (hCG) pregnancy test on Day 1. 8. Written informed consent signed by the patient or her legal representative prior to any study-related procedures not part of normal medical care. Exclusion criteria: 1. Participation in the active treatment phase of an investigational drug study ≤ 2 month prior to randomization. 2. Adjuvant trastuzumab therapy ≤ 6 months prior to randomization. 3. Taxane-based chemotherapy ≤ 1 year prior to randomization. 4. Any concomitant chemotherapy or HER2 directed therapy for MBC, from Screening and throughout the trial. 5. Surgery or radiotherapy ≤ 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. Concomitant anti-tumor endocrine or immunotherapy. Priort reatment with hormonal agents or bisphosphonates is allowed. 7. Active brain metastases, defined as metastases that within the past 4 weeks: are symptomatic and/or require change of anticonvulsive or steroid treatment and/or are associated with leptomeningeal disease. Stable and treated brain metastases are allowable; patients with known or suspected brain metastases must undergo a baseline brain computed tomography (CT) or magnetic resonance imaging (MRI). 8. Presence of unstable angina or a history of congestive heart failure (CHF) according to the New York Heart Association (NYHA) criteria, history of myocardial infarction, clinically significant valvular disease, serious cardiac arrhythmia requiring treatment, uncontrolled hypertension or known pulmonary hypertension. 9. Presence or history of serious pulmonary illnesses or dyspnea at rest. 10. Left ventricular ejection fraction (LVEF) < 50%. 11. Screening laboratory parameters within the following values: a) Absolute neutrophil count (ANC) < 1500/μL b) Thrombocytes < 100,000/μL c) Hemoglobin < 9 g/dL d) Serum creatinine > 177 μmol/L e)Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 x ULN (upper limit of normal), or > 3.5 x ULN in patients with liver metastases f)Serum total bilirubin > 1.5 x ULN, except predominant unconjugated hyperbilirubinemia in patients with history of Gilbert syndrome g) Alkaline phosphate > 2.5 ULN, or > 6.0 x ULN in patients with liver metastases. 12. History of any other malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin or cervical carcinoma in situ. 13. History or presence of a medical condition or disease that in the investigator's opinion would place the patient at an unacceptable risk from study participation. 14. Patients known to be positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) virus. 15. Breastfeeding or pregnant patients. 16. Patients with documented severe hypersensitivity reaction to trastuzumab or docetaxel or excipients used in their formulations. 17. Peripheral sensory or motor neuropathy grade 2 or higher according to the National Cancer Institute Common Terminology Criteria (NCI CTC).

Interventional

Hercules

comparison between investigation drug versus herceptin (marketed drug)

Randomized

Double Blind

Unspecified

Single Arm

comparison between investigation drug versus herceptin (marketed drug)

Phase III

28

49

Over recruitment of sites

16 Nov 2012

Utilization Utilization Info
No records found.

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