Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ - Full Text View

Sponsor:	Cancer Research UK
Collaborator:	International Breast Cancer Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072462

Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

Condition	Intervention	Phase
Breast Cancer	Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control
Official Title:	An International Multi-Centre Study Of Tamoxifen Vs Anastrozole In Postmenopausal Women With Ductal Carcinoma In Situ (DCIS)

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 National Cancer Institute (NCI):

Primary Outcome Measures:

Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Breast cancer mortality with median follow-up at 10 years [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	September 2003

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ.
Compare side effect profiles of these drugs in these patients.

Secondary

Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients.
Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients.
Compare breast cancer mortality in patients treated with these drugs.
Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients.
Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral tamoxifen and oral placebo once daily.
Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity.

Patients are followed annually for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of ductal carcinoma in situ within the past 6 months
- Locally excised with tumor-free margins at least 1 mm
Hormone receptor status:
- Estrogen or progesterone receptor positive
  - Greater than 5% positive cells

PATIENT CHARACTERISTICS:

Age

40 to 70

Sex

Female

Menopausal status

Postmenopausal, defined as meeting at least 1 of the following criteria:
- Over age 60
- Prior bilateral oophorectomy
- Age 60 or under with a uterus AND amenorrhea for at least the past 12 months
- Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L

Performance status

Not specified

Life expectancy

At least 10 years

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No prior deep vein thrombosis
No prior transient ischemic attack
No prior cerebrovascular accident

Pulmonary

No prior pulmonary embolism

Other

No unexplained postmenopausal bleeding
No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results
No evidence of osteoporosis
Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures
Psychologically and physically suitable for 5 years of study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No prior or concurrent tamoxifen use lasting more than 3 months unless treatment was completed more than 5 years ago
No prior or concurrent raloxifene use lasting more than 3 months unless treatment was completed more than 5 years ago
No other prior or concurrent selective estrogen-receptor modulator use lasting more than 3 months unless treatment was completed more than 5 years ago
No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations

Radiotherapy

Not specified

Surgery

See Disease Characteristics
No prior mastectomy
No planned prophylactic mastectomy

Other

At least 3 months since prior unapproved or experimental agents
No concurrent anticoagulants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072462

Show 46 Study Locations

Sponsors and Collaborators

Cancer Research UK

International Breast Cancer Study Group

Investigators

Investigator:	Jack Cuzick, PhD	Cancer Research UK
Study Chair:	Katharina S. Buser, MD	Oncocare Sonnenhof-Klinik Engeriedspital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Jenkins VA, Ambroisine LM, Atkins L, Cuzick J, Howell A, Fallowfield LJ. Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II). Lancet Oncol. 2008 Oct;9(10):953-61. Epub 2008 Sep 1.

Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008 Sep;11(3):252-62.

Study ID Numbers:	CDR0000339738, CRUK-IBIS-II-DCIS, EU-20226, BIG-5-02, IBCSG-31-03-DCIS, ISRCTN31488319
Study First Received:	November 4, 2003
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00072462 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Carcinoma in Situ
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

Estrogen Antagonists
Neoplasms by Histologic Type
Skin Diseases
Antineoplastic Agents, Hormonal
Adjuvants, Immunologic
Breast Neoplasms
Enzyme Inhibitors
Tamoxifen
Pharmacologic Actions
Carcinoma
Carcinoma, Ductal
Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on November 09, 2009