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

NCT00776659 | Terminated Results

• 1 other identifier: A5991088
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 4

Brief Summary

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®

Conditions

Breast Neoplasms

Keywords

An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin; Antineoplastic Hormonal Drugs; Aromasin

Outcome Measures

Primary Outcomes (7)

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

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

  Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)

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

  Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)

• Number of Participants Who Died

  Baseline until death (up to Year 3.5)

• Number of Participants Who Discontinued Aromasin Therapy

  Baseline until discontinuation (up to Year 3.5)

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

  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.

  Baseline up to 28 days after last dose of study treatment

• 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

  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

  Baseline, Month 6, 12, 18, 24, 30, 36, 42

Study Arms (1)

Observational

Other: Aromasin

Interventions

Aromasin OTHER

Non-Interventional study design.

Also known as: exemestane

Observational

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

You may qualify if:

• Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Bangalore, Karnataka, 560 029, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 004, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 009, India

Location

Pfizer Investigational Site

Lucknow, Uttar Pradesh, 226 001, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 19, 2013
• Results First Posted: November 19, 2013

Record last verified: 2013-09

Locations

IN (4)