Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China
| Tracking Information | |||||
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| First Received Date ICMJE | August 4, 2010 | ||||
| Last Updated Date | June 4, 2013 | ||||
| Start Date ICMJE | February 2011 | ||||
| Estimated Primary Completion Date | December 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time-to-event, where event is defined as the earliest occurrence any of the following: Locoregional/distant recurrence of the primary breast cancer; Appearance of 2nd primary or contralateral breast cancer; Death [ Time Frame: 7 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01176916 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China | ||||
| Official Title ICMJE | A Prospective Non-Interventional Study Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin® | ||||
| Brief Summary | Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population. |
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| Detailed Description | This is non-interventional study and single arm study. N/A |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Postmenopausal women with primary breast cancer with estrogen receptor positive switching to adjuvant Aromasin® endocrine therapy following adjuvant Tamoxifen therapy for 2-3 years |
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| Condition ICMJE | Breast Neoplasms | ||||
| Intervention ICMJE | Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
Other Name: Aromasin (exemestane) |
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| Study Group/Cohort (s) | 1.0
This is a single arm NIS.
Intervention: Drug: Aromasin (exemestane) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 550 | ||||
| Estimated Completion Date | December 2017 | ||||
| Estimated Primary Completion Date | December 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01176916 | ||||
| Other Study ID Numbers ICMJE | A5991093 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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