Experimental: Neratinib mg orally daily for one year.
Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Korhaz es Egyetemi Okt. Olsztyn, Poland, Szpital Wojewodzki im. More Information. Secondary Outcome Measures : Overall Survival OS [ Time Frame: Randomization until death due to any cause up to Months ] OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Breast Cancer. History of heart disease. Actual Enrollment :.
Outcome Measures. Future Oncol. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. MedlinePlus related topics: Breast Cancer.
National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. Washington, District of Columbia, United States, Loxahatchee Groves, Florida, United States, Indianapolis, Indiana, United States, Wilmington, North Carolina, United States, Philadelphia, Pennsylvania, United States, Willow Grove, Pennsylvania, United States, Charleston, South Carolina, United States, Texas Oncology - Baylor Charles A.
Sammons Cancer Center. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer.
Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Distant Disease-free Survival DDFS in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ] Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
Actual Study Completion Date :. The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from ly diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
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For general information, Learn About Clinical Studies. Phase 3. Any patient-level data will be anonymized to protect personally identifiable information. Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.
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North Adelaide, South Australia, Australia, Specialised Hospital of Active Treatment in Oncology. Epub Nov Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer ExteNET : a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
Study record managers: refer to the Data Element Definitions if submitting registration or information. Actual Primary Completion Date :. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Actual Study Start Date :. Placebo Comparator: Placebo orally daily for one year. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties.
Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information. Eligibility Criteria.
Please refer to this study by its ClinicalTrials. Epub Feb In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study on clinical trial registries, including ClinicalTrials. First Posted : October 9, Last Update Posted : June 11, Study Description. Exclusion Criteria: Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Search for terms.
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Publications automatically indexed to this study by ClinicalTrials. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Been treated for early breast cancer with standard of care duration of trastuzumab.
Drug: neratinib Other: placebo. Klinicki bolnicki centar "Sestre Milosrdnice". Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence. Could have been treated neoadjuvantly but have not reached pathologic complete response.
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Interventional Clinical Trial. Pandy Kalman Korhaz, Megyei Onkol.
Save this study. Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause. Lancet Oncol. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
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Talk with your doctor and family members or friends about deciding to a study. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer ExteNET : 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Contacts and Locations. FDA Resources. Epub May Breast Cancer Res. Ann Oncol. Read our disclaimer for details. Arms and Interventions.
Drug Information available for: Neratinib. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials pumabiotechnology. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Study Type :.