Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

NCT01155063 | Terminated Results

• 1 other identifier: A5991092
• Study Type: observational
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.

Conditions

Early Breast Cancer

Keywords

Exemestane; Adjuvant Treatment In Postmenopausal Women; Estrogen Receptor Positive Early Breast Cancer; Tamoxifen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.

  Month 0 up to Month 36 or early withdrawal

Secondary Outcomes (6)

• Number of Participants With Concomitant Morbidities

  Month 0 up to Month 36 or early withdrawal

• Number of Participants With Concomitant Medications

  Month 0 up to Month 36 or early withdrawal

• Percentage of Participants Who Discontinued the Study Medication

  Month 0 up to Month 36 or early withdrawal

• Number of Participants With Reasons for Discontinuation From Study Treatment

  Month 0 up to Month 36 or early withdrawal

• Time to Discontinuation of Study Medication

  Month 0 up to Month 36 or early withdrawal

Study Arms (1)

Main Group

Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Other: Aromasin (exemestane)

Interventions

Aromasin (exemestane) OTHER

Aromasin (exemestane), tablets 25 mg, once a day

Also known as: Aromasin, exemestane

Main Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

You may qualify if:

• Postmenopausal females.
• Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
• Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
• Patients whose tumour was estrogen receptor positive (ER+).
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

• Patients for whom Aromasin® treatment is contraindicated (see SPC).
• Presence of metastasis or a contra lateral tumour.
• Other adjuvant endocrine therapy.
• Another concomitant antineoplastic treatment.
• Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Sponsors & Collaborators

• Pfizer: lead

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

The study was prematurely discontinued, therefore not all data was analyzed and only one outcome measure timeframe was presented.

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 CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 1, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 1, 2012
• Results First Posted: September 20, 2012

Record last verified: 2012-09