An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
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ClinicalTrials.gov Identifier: NCT00776659 |
Recruitment Status
:
Terminated
(See termination reason in detailed description.)
First Posted
: October 21, 2008
Results First Posted
: November 19, 2013
Last Update Posted
: November 19, 2013
|
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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 or disease | Intervention/treatment |
---|---|
Breast Neoplasms | Other: Aromasin |
Study Type : | Observational |
Actual Enrollment : | 39 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Group/Cohort | Intervention/treatment |
---|---|
Observational |
Other: Aromasin
Non-Interventional study design.
Other Name: exemestane
|
- 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) ]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) ]
- Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ]
- Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ]
- 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 ]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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776659
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00776659 History of Changes |
Other Study ID Numbers: |
A5991088 |
First Posted: | October 21, 2008 Key Record Dates |
Results First Posted: | November 19, 2013 |
Last Update Posted: | November 19, 2013 |
Last Verified: | September 2013 |
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 |