To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.
- Efficacy of the treatment with Aromasin®
- Safety of the treatment with Aromasin®
- Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be
eligible.
- Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a
2nd primary will not be included.
- Patients with a known hypersensitivity to Exemestane or its metabolites will also not
be included.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin | |||
| Official Title | An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin | |||
| Brief Summary | To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.
| |||
| Detailed Description | NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible. | |||
| Condition | Breast Neoplasms | |||
| Intervention | Other: Aromasin Non-Interventional study design. Other Name: exemestane | |||
| Study Groups/Cohorts | Observational Intervention: Other: Aromasin | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Terminated | |||
| Actual Enrollment | 39 | |||
| Original Estimated Enrollment | 100 | |||
| Actual Study Completion Date | September 2012 | |||
| Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | India | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00776659 | |||
| Other Study ID Numbers | A5991088 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2013 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
