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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


Phase 4
N/A
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of Participants With Adverse Events (AEs)

Outcome Description:

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.

Outcome Time Frame:

Baseline up to Month 36

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Croatia: Ministry of Health and Social Care

Study ID:

A5991094

NCT ID:

NCT01239745

Start Date:

April 2011

Completion Date:

October 2011

Related Keywords:

  • Breast Neoplasms
  • Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
  • Breast Neoplasms
  • Neoplasms

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