An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00776659
First received: October 20, 2008
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
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®
| Condition | Intervention |
|---|---|
|
Breast Neoplasms |
Other: Aromasin |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Exemestane
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Locoregional/distant recurrence of the primary breast cancer [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Appearance of 2nd primary or contralateral breast cancer [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Death [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
- Discontinuation from Aromasin therapy [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Changes in lipid measurements (HDL-C, LDL-C, total cholesterol and triglycerides) and bone mineral density [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
- Incidence and severity of adverse events, in particular the specific events of interest (gynaecological, cardiac, thromboembolic , musculoskeletal, and menopausal) [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | December 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Observational |
Other: Aromasin
Non-Interventional study design.
Other Name: exemestane
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
Criteria
Inclusion Criteria:
- Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776659
Locations
| India | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 029 | |
| Pfizer Investigational Site | |
| Ludhiana, Punjab, India, 141 009 | |
| Pfizer Investigational Site | |
| Ludhiana, Punjab, India, 141 004 | |
| Pfizer Investigational Site | |
| Lucknow, Uttar Pradesh, India, 226 001 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00776659 History of Changes |
| Other Study ID Numbers: | A5991088 |
| Study First Received: | October 20, 2008 |
| Last Updated: | May 20, 2013 |
| Health Authority: | India: Soumya Multi Specialty Hospital Ethics Committee |
Keywords provided by Pfizer:
|
An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin Antineoplastic Hormonal Drugs Aromasin |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adjuvants, Immunologic Exemestane Antineoplastic Agents, Hormonal |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013