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

• ClinicalTrials.gov Identifier: NCT01239745
• Recruitment Status: Terminated
• First Posted: November 11, 2010
• Results First Posted: October 31, 2012
• Last Update Posted: October 31, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Breast Neoplasms	Drug: Aromasin

Detailed Description:

The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Study Design

• Study Type: Observational
• Actual Enrollment: 46 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
• Study Start Date: April 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 2011

Groups and Cohorts

Group/Cohort	Intervention/treatment
1	Drug: Aromasin; Aromasin® one 25 mg tablet to be taken once daily; Other Name: Exemestane

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Month 36 ]
   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.

Secondary Outcome Measures :

1. Number of Participants With Concomitant Morbidities [ Time Frame: Baseline up to Month 36 ]
   Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
2. Number of Participants With Concomitant Medications [ Time Frame: Baseline up to Month 36 ]
   Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
3. Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Baseline up to Month 36 ]
4. Number of Participants With Reasons for Discontinuation From Study Medication [ Time Frame: Baseline up to Month 36 ]
5. Time to Discontinuation [ Time Frame: Baseline up to Month 36 ]
6. Recurrence-free Survival [ Time Frame: Baseline up to Month 36 ]
   Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
7. Overall Survival [ Time Frame: Baseline until death (up to Month 36) ]
   Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Estrogen receptor positive early breast cancer patients

Criteria

Inclusion Criteria:

• Postmenopausal females, defined as one from the next :

  1. Natural menopause ≥1 year,
  2. Surgical ovariectomy,
  3. 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Croatia

General Hospital Karlovac

Karlovac, Croatia, 47000

University Hospital Center Osijek

Osijek, Croatia, 31000

General Hospital Pula

Pula, Croatia, 52000

University Hospital Center Rijeka

Rijeka, Croatia, 51000

University Hospital Center Split

Split, Croatia, 21000

General Hospital Varazdin

Varazdin, Croatia, 42000

Clinic for Tumors

Zagreb, Croatia, 10000

University Hospital Center "Sestre milosrdnice"

Zagreb, Croatia, 10000

Estonia

North Estonia Medical Centre Foundation

Tallinn, Estonia, 13419

Serbia

Institute for Oncology and Radiology of Serbia

Belgrade, Serbia, 11000

Oncology Clinic, Medical center, Bezanijska Kosa

Beograd, Serbia, 11080

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01239745
• Other Study ID Numbers: A5991094
• First Posted: November 11, 2010
• Results First Posted: October 31, 2012
• Last Update Posted: October 31, 2012
• Last Verified: October 2012

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Exemestane; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs