A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
NCT01121549
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- 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.
- 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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| 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 | 378 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2013 | |||