A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

NCT01305239 | Terminated Results

• 2 other identifiers: NRA5990024A5991095, ETAPE
• Study Type: observational
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

Conditions

Breast Cancer

Keywords

Observational; epidemiological; cohort; cross-sectional; prospective; multicenter; survey; France.

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Secondary Outcomes (4)

• Reasons for Discontinuation of Aromasin Therapy

  Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

• Percentage of Participants Who Were Compliant With Treatment

  Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

• Duration of Treatment

  Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

• Event-free Survival

  Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Study Arms (1)

Postmenopausal ER+ patients treated by Aromasin.

Drug: Aromasin

Interventions

Aromasin DRUG

Aromasin 25 mg daily.

Also known as: Exemestane

Postmenopausal ER+ patients treated by Aromasin.

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal patients, hormone receptor positive, who have had surgical treatment for histologically confirmed early breast cancer that was nonmetastatic at the time of the initial diagnosis, treated by Aromasin as adjuvant endocrine therapy.

You may qualify if:

• Postmenopausal patients, defined as: natural menopause for at least 1 year, surgical ovariectomy, chemotherapy-induced amenorrhoea for at least 2 years.
• Patients who have had surgical treatment for histologically confirmed breast cancer that was nonmetastatic at the time of the initial diagnosis.

You may not qualify if:

• Patients for whom Aromasin treatment is contraindicated. Presence of metastasis or a contralateral tumour. Another adjuvant endocrine therapy. Another concomitant antineoplastic treatment (except for Herceptin®). 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

Study recruitment was stopped due to difficulty enrolling the target number of participants. There were no safety concerns in the decision to terminate this study.

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

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 28, 2011
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 10, 2012
• Results First Posted: April 10, 2012

Record last verified: 2011-11