Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00605267

Purpose

Japanese breast cancer medical experts in Japan have been strongly requesting the additional indication of anastrozole (Arimidex) for premenopausal breast cancer patients receiving an anti-hormonal, because there are no other effective endocrine therapies except tamoxifen. It is important therefore, to develop anastrozole as a new treatment option for pre-menopausal breast cancer in Japan.The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group during 24 weeks pre-operative administration, for premenopausal breast cancer patients additionally receiving Zoladex 3.6mg/month. Secondary objectives include investigation of the treatment safety in the two patient groups by examination of adverse events, clinical laboratory values, blood pressure, pulse rate, and the World Health Organisation (WHO) performance status.

Condition	Intervention	Phase
Breast Cancer	Drug: Tamoxifen Drug: Anastrazole (Arimidex) Drug: Goserelin acetate (Zoladex)	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Tamoxifen Tamoxifen citrate Goserelin Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Centre, Randomised, Double-Blind, Parallel-Group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-Operative Administration Under Luteinising Hormone-Releasing Hormone Agonist Treatment for Premenopausal Breast Cancer Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group, during 24 weeks pre-operative administration, for premenopausal breast cancer patients receiving Zoladex 3.6mg/month [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of anastrozole and tamoxifen groups by: adverse events, lab. tests, blood pressure, pulse rate, WHO performance status and change in bone mineral density and bone turnover markers. Additional efficacy markers [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	204
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Tamoxifen	Drug: Tamoxifen 20 mg once daily oral dose Drug: Goserelin acetate (Zoladex) 3.6mg/month depot injection
2: Experimental Anastrazole (Arimidex)	Drug: Anastrazole (Arimidex) 1 mg once daily oral dose Drug: Goserelin acetate (Zoladex) 3.6mg/month depot injection

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provide written informed consent

Exclusion Criteria:

Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605267

Contacts

Contact: Toshiyuki Kihara, MD

81 6 6453 7996

T.Kihara@astrazeneca.com

Locations

Japan
Research Site	Not yet recruiting
Kumamoto, Japan
Research Site	Recruiting
Nagoya, Japan
Research Site	Not yet recruiting
Osaka, Japan
Japan, Fukuoka
Research Site	Not yet recruiting
Hakata, Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Toshiyuki Kihara

Clinical

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Francisco Sapunar )
Study ID Numbers:	D539BC00001
Study First Received:	January 9, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00605267
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Breast Cancer
Breast Neoplasms
Tumors or cancer of the human BREAST
Tumor or cancer of the human MAMMARY GLAND

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Anastrozole
Skin Diseases
Guaifenesin
Phenylephrine

Goserelin
Breast Neoplasms
Phenylpropanolamine
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 14, 2009