Know Cancer

or
forgot password

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


Phase 4
N/A
N/A
Not Enrolling
Female
Invasive Early Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Overall Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Romania: Romanian National Medicine Agency

Study ID:

A5991091

NCT ID:

NCT01121549

Start Date:

February 2010

Completion Date:

December 2012

Related Keywords:

  • Invasive Early Breast Cancer
  • Prospective
  • non-comparative
  • NIS
  • 600
  • postmenopausal
  • hormone-receptor
  • positive
  • EBC
  • tamoxifen
  • current medical practice.
  • Breast Neoplasms

Name

Location