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| Sponsor: | Bayer |
|---|---|
| Collaborator: |
Onyx Therapeutics, Inc. |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01234337 |
Purpose
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Sorafenib(Nexavar, BAY43-9006) / Capecitabine Drug: Placebo / Capecitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer |
| Estimated Enrollment: | 519 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Sorafenib(Nexavar, BAY43-9006) / Capecitabine
Three sorafenib tablets will be administered daily; as 1 tablet in the morning, followed by 2 tablets in the evening . The two doses should be administered approximately 12 hours apart, and at least 1 hour before or al least 2 hours after a meal. For 21 days. Capecitabine will be administered orally at a total daily dose of 2,000 mg/m2; 1,000 mg/m2 administered twice daily, 12 hours apart, each within 30 minutes of a meal for 14 days.
|
| Placebo Comparator: Arm 2 |
Drug: Placebo / Capecitabine
Three placebo tablets will be administered daily; as 1 tablet in the morning, followed by 2 tablets in the evening. The two doses should be administered approximately 12 hours apart, and at least 1 hour before or al least 2 hours after a meal for 21 days. Capecitabine will be administered orally at a total daily dose of 2,000 mg/m2; 1,000 mg/m2 administered twice daily, 12 hours apart, each within 30 minutes of a meal for 14days.
|
Research summary (NRES, UK):
Breast cancer is the most commonly diagnosed cancer in women and the leading cause of cancer-related death among women worldwide.
However, despite advances in treatment of the early-stage disease, about 25-40% of patients will develop recurrence or spread to other parts of the body that is largely incurable. The average survival of patients with breast cancer that has spread to other parts of the body (metastasis) is 2 to 3 years after diagnosis, and although a number of treatment options are available, including various chemotherapy agents, no single standard of care exists.
The study drug (Sorafenib) works by inhibiting certain pathways in the body that contribute to tumour growth and the formation of new blood vessels (angiogenesis). Angiogenesis plays an important role in the development, transformation and spread of breast cancer. Capecitabine is an approved chemotherapy drug for patients whose breast cancer has spread to other parts of the body (metastatic) and is not responsive to other classes of chemotherapy drugs.
Data from a Phase IIb clinical study suggests that there is a role for the combination of Sorafenib and Capecitabine to treat locally advanced or metastatic breast cancer.
Patients in this confirmatory Phase III study will be randomly assigned to receive either:
Participants will continue to receive treatments until there is radiographic or clinical progression of disease, side effects which require them to withdraw, pregnancy, protocol non-compliance or withdrawal of consent. Therefore length of participation will vary for individuals. This study is expected to close 31 March 2013.
This is a multicentre study which will take place across Europe, North and South America, Asia, Australia and South Africa. It is anticipated that approximately 519 participants will be recruited worldwide.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Show 213 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01234337 History of Changes |
| Other Study ID Numbers: | 12444, 2010-018501-10 |
| Study First Received: | October 4, 2010 |
| Last Updated: | May 22, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Austria : Federal Ministry for Labour, Health, and Social Affairs Belgium: Directorate general for the protection of Public health: Medicines Brazil: Ministry of Health Canada: Health Canada Chile: Comisión Nacional de Investigación Científica y Tecnológica China: Ministry of Health Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: Ministry of Health and Welfare Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Japan: Ministry of Health, Labor and Welfare Mexico: National Institute of Public Health, Health Secretariat New Zealand: Health Research Council Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Russia: Ministry of Health and Social Development of the Russian Federation South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Federal Office of Public Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
|
Breast Cancer HER2-neu |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Fluorouracil Sorafenib Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors |