Clinical trial NCT01239745: Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 46
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Estrogen receptor positive early breast cancer patients

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.

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 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Month 36
Secondary outcomes:
measure: Number of Participants With Concomitant Morbidities
timeFrame: Baseline up to Month 36
measure: Number of Participants With Concomitant Medications
timeFrame: Baseline up to Month 36
measure: Percentage of Participants Who Discontinued the Study Medication
timeFrame: Baseline up to Month 36
measure: Number of Participants With Reasons for Discontinuation From Study Medication
timeFrame: Baseline up to Month 36
measure: Time to Discontinuation
timeFrame: Baseline up to Month 36
measure: Recurrence-free Survival
timeFrame: Baseline up to Month 36
measure: Overall Survival
timeFrame: Baseline until death (up to Month 36)
Other outcomes:
Locations:
city: Karlovac
country: Croatia
facility: General Hospital Karlovac
city: Osijek
country: Croatia
facility: University Hospital Center Osijek
city: Pula
country: Croatia
facility: General Hospital Pula
city: Rijeka
country: Croatia
facility: University Hospital Center Rijeka
city: Split
country: Croatia
facility: University Hospital Center Split
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: Clinic for Tumors
city: Zagreb
country: Croatia
facility: University Hospital Center "Sestre milosrdnice"
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Beograd
country: Serbia
facility: Oncology Clinic, Medical center, Bezanijska Kosa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: