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: September 12, 2013
Last verified: September 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:
- Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer [ Time Frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) ] [ Designated as safety issue: Yes ]Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
- Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer [ Time Frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) ] [ Designated as safety issue: Yes ]
- Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ] [ Designated as safety issue: Yes ]
- Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ] [ Designated as safety issue: No ]
- Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study treatment ] [ Designated as safety issue: Yes ]An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
- Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ] [ Designated as safety issue: Yes ]
- Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ] [ 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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776659
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, 141 004 | |
| Pfizer Investigational Site | |
| Ludhiana, Punjab, India, 141 009 | |
| 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:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00776659 History of Changes |
| Other Study ID Numbers: | A5991088 |
| Study First Received: | October 20, 2008 |
| Results First Received: | September 12, 2013 |
| Last Updated: | September 12, 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 by Site Neoplasms Breast Diseases Skin Diseases Exemestane Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016