Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Exemestane

Antineoplastic Agents, Hormonal

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Aromasin

Pfizer CT.gov Call Center

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®

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.

An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.

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.

Pfizer

Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.

Age Continuous

Sex: Female, Male

Study was terminated due to slow enrollment and observational nature of the study. Low number of participants enrolled was not sufficient to conduct the planned analysis. Study was not terminated due to safety concerns.

Pfizer ClinicalTrials.gov Call Center

Locoregional/Distant Recurrence

Missing/No response

Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer

Second primary or contralateral breast cancer

FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer

FAS included all enrolled participants who received at least 1 dose of aromasin therapy.

Number of Participants Who Died

Number of Participants Who Discontinued Aromasin Therapy

Gynecological AEs

Cardiac AEs

Venous thromboembolic events

Musculoskeletal AEs

Menopausal symptoms

Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)

Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.

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

Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.

Spots Global Cancer Trial Database for An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

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