ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-Positive Breast Cancer With Good to Moderate Differentiation.

This study has been completed.

First Received: February 13, 2006 Last Updated: February 8, 2007 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00291759

Purpose

The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen.

Condition	Intervention	Phase
Breast Cancer	Drug: Tamoxifen Drug: Anastrozole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Adjuvant Endocrine Therapy in Postmenopausal Patients With HR +ve BC With Good to Moderate Differentiation - ARNO (Arimidex + Nolvadex). Primary Treatment for 2 Years With Tamoxifen Thereafter Randomisation to: Tamoxifen 3 Years or Anastrozole 3 Years.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the difference in event free survival and overall survival (subject to stand-alone or combined/meta-analysis) between postmenopausal women with HR +ve early BC who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Secondary Outcome Measures:

To assess the difference in event free survival & overall survival (subject to stand-alone or combined/meta-analysis) plus side effects between postmenopausal women with HR+ve early BC who switched from tam to anastrozole and those who continued on tam.

Estimated Enrollment:	3900
Study Start Date:	January 1996

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Invasive mammary carcinoma after radical treatment, without prior chemo/hormone/radiation therapy.
At least 6 lymph nodes examined.
Good or intermediate tumour differentiation.
<6 weeks before start of adjuvant therapy.
Oestrogen or Progesterone positive

Exclusion Criteria:

Premenopausal.
Preoperative hormonal/antihormonal/radiation/cytoxic chemo. Second malignant tumour/status post second malignant tumour.
In-situ/T4 carcinoma.
Age >80 years.
World Health Organisation performance index >3.
Serious accompanying diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291759

Show 52 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Raimund Jakesz, MD	Austrian Breast and Colorectal Cancer Study Group
Study Director:	AstraZeneca Austria Medical Director, MD	AstraZeneca

More Information

No publications provided

Study ID Numbers:	1033AU/0002, ABCSG 8
Study First Received:	February 13, 2006
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00291759 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:

Estrogen Antagonists
Anastrozole
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010