Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

NCT01239745 | Terminated Results

• 1 other identifier: A5991094
• Study Type: observational
• Target: 46
• Locations: 3 countries
• Sites: 11

Brief Summary

This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

Conditions

Breast Neoplasms

Keywords

Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  Baseline up to Month 36

Secondary Outcomes (7)

• Number of Participants With Concomitant Morbidities

  Baseline up to Month 36

• Number of Participants With Concomitant Medications

  Baseline up to Month 36

• Percentage of Participants Who Discontinued the Study Medication

  Baseline up to Month 36

• Number of Participants With Reasons for Discontinuation From Study Medication

  Baseline up to Month 36

• Time to Discontinuation

  Baseline up to Month 36

Study Arms (1)

1

Drug: Aromasin

Interventions

Aromasin DRUG

Aromasin® one 25 mg tablet to be taken once daily

Also known as: Exemestane

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Estrogen receptor positive early breast cancer patients

You may qualify if:

• Postmenopausal females, defined as one from the next :
• Natural menopause ≥1 year,
• Surgical ovariectomy,
• Chemotherapy-induced amenorrhoea ≥ 2 years.
• Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
• Patients who are disease-free after 2 to 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 SmPC).
• Metastatic breast cancer or a contra lateral tumour.
• Other concomitant adjuvant endocrine therapy.
• Other 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

Study Sites (11)

General Hospital Karlovac

Karlovac, 47000, Croatia

Location

University Hospital Center Osijek

Osijek, 31000, Croatia

Location

General Hospital Pula

Pula, 52000, Croatia

Location

University Hospital Center Rijeka

Rijeka, 51000, Croatia

Location

University Hospital Center Split

Split, 21000, Croatia

Location

General Hospital Varazdin

Varaždin, 42000, Croatia

Location

Clinic for Tumors

Zagreb, 10000, Croatia

Location

University Hospital Center "Sestre milosrdnice"

Zagreb, 10000, Croatia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Institute for Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Oncology Clinic, Medical center, Bezanijska Kosa

Belgrade, 11080, Serbia

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

The study was prematurely discontinued, therefore not all data was analyzed.

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: November 3, 2010
• First Posted: November 11, 2010
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 31, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-10

Locations

CR (8); SE (2); ES (1)