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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01239745
First received: November 3, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Breast Neoplasms
Drug: Aromasin
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: Yes ]
    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:
  • Number of Participants With Concomitant Morbidities [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Concomitant Medications [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
  • Number of Participants With Reasons for Discontinuation From Study Medication [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
  • Time to Discontinuation [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
  • Recurrence-free Survival [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Baseline until death (up to Month 36) ] [ Designated as safety issue: No ]
    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).


Enrollment: 46
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Aromasin
Aromasin® one 25 mg tablet to be taken once daily
Other Name: Exemestane

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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239745

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01239745     History of Changes
Other Study ID Numbers: A5991094
Study First Received: November 3, 2010
Results First Received: October 11, 2012
Last Updated: October 11, 2012
Health Authority: Croatia: Ministry of Health and Social Care

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
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogens
Exemestane
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014