You are here

A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aalst, , 9300 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
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 patients

- Patients with early breast cancer after adequate loco-regional treatment and eventual
adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen
for 2-3 years and consecutive exemestane treatment, provided the total duration of
endocrine treatment is less than 5 years

- Estrogen receptor positive breast cancer patients

- Patients who remain free from disease following treatment with tamoxifen

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients taking other drugs for the adjuvant treatment of breast cancer

- Patients taking hormone replacement therapy

- Donation of blood or blood products for transfusion during the 30 days prior to
initiation of treatment with study drug, at any time during the program or 30 days
after completion of treatment

NCT00649090
Pfizer
Completed
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Breast Neoplasms
NCT01176916
Females
0+
Years
Multiple Sites
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Advanced Breast Cancer, Metastatic Breast Cancer
NCT03280303
All Genders
18+
Years
Multiple Sites
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer
A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)
The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: exemestane
Exemestane 25 mg oral tablet once daily for a maximum of 3 years
Active Comparator: Exemestane group
Intervention: Drug: exemestane
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1549
April 2007
April 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal patients
  • Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
  • Estrogen receptor positive breast cancer patients
  • Patients who remain free from disease following treatment with tamoxifen

Exclusion Criteria:

  • Patients taking other drugs for the adjuvant treatment of breast cancer
  • Patients taking hormone replacement therapy
  • Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00649090
A5991077
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now