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Trial record 1 of 1 for:    NCT01239745
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Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01239745
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 11, 2010
Results First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

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

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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01239745

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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
North Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Oncology Clinic, Medical center, Bezanijska Kosa
Beograd, Serbia, 11080
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT01239745    
Other Study ID Numbers: A5991094
First Posted: November 11, 2010    Key Record Dates
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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