A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

NCT01121549

Last updated date
Study Location
Policlinica Judeteana 1 Pitesti - Cabinet oncologie
Pitesti, Arges, 110084, Romania
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Early Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.

- Patients who are disease-free after 2 or 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients for whom Aromasin® treatment is contraindicated (see SmPC).


- Presence of metastasis or a contra lateral tumour.


- Other adjuvant endocrine therapy.


- Another concomitant antineoplastic treatment


- Participation in a clinical trial with an investigational drug during the 30 days
prior to enrolment in the study.


- The patients are not supposed to participate to any other trial during all the study
period.

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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
Official Title A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
Brief Summary The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
Detailed Description This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy
Condition Invasive Early Breast Cancer
Intervention Drug: Aromasin
25 mg daily continuously
Other Name: exemestane
Study Groups/Cohorts Aromasin
All patients included in the study
Intervention: Drug: Aromasin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 8, 2012)
378
Original Estimated Enrollment
 (submitted: May 11, 2010)
600
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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 histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
  • Patients who are disease-free after 2 or 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).
  • Presence of metastasis or a contra lateral tumour.
  • Other adjuvant endocrine therapy.
  • Another concomitant antineoplastic treatment
  • Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
  • The patients are not supposed to participate to any other trial during all the study period.
Sex/Gender
Sexes Eligible for Study:Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT01121549
Other Study ID Numbers A5991091
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2013