Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer - Full Text View

Sponsor:	Queen Mary University of London
Collaborator:	International Breast Cancer Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00078832

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.

PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.

Condition	Intervention
Breast Cancer	Drug: anastrozole

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	An International Multi-Centre Study Of Anastrozole Versus Placebo In Postmenopausal Women At Increased Risk Of Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: 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:	6000
Study Start Date:	September 2003

Detailed Description:

OBJECTIVES:

Primary

Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.

Secondary

Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.
Determine the effect of this drug on breast cancer mortality in these participants.
Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
Determine the tolerability and acceptability of side effects of this drug in these participants.

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

Arm I: Participants receive oral anastrozole daily for 5 years.
Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture.

Participants are followed for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Meets at least 1 of the relative risk factors based on age as follows:
- 45 to 70 years of age:
  - First-degree relative who developed breast cancer at ≤ 50 years of age
  - First-degree relative who developed bilateral breast cancer
  - Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
    - Participants having both relatives who are second degree and on the opposite sides of the family must have at least one that was diagnosed at ≤ 50 years of age
  - Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer
  - Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer
  - Mammographic opacity covering at least 50% of the breast in the absence of hormone replacement therapy within the past 3 months
- 60 to 70 years of age:
  - First-degree relative with breast cancer at any age
  - Age at menopause ≥ 55 years
  - Nulliparous or age at first birth ≥ 30 years
- 40 to 44 years of age:
  - Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer at ≤ 50 years of age
  - First-degree relative with bilateral breast cancer who developed the first breast cancer at ≤ 50 years of age
  - Nulliparous (or first birth at ≥ 30 years of age) and a first-degree relative who developed breast cancer at ≤ 40 years of age
  - Benign biopsy with proliferative disease and a first-degree relative who developed breast cancer at ≤ 40 years of age
All age groups (40 to 70 ears of age) with a 10-year risk > 5% who do not fit into the above categories are allowed
- Clearly apparent family history AND/OR other risk factors indicating appropriate increased risk of breast cancer for age
The following prior breast conditions are allowed (for all age groups):
- Lobular carcinoma in situ
- Atypical ductal or lobular hyperplasia in a benign lesion
- Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated by mastectomy
No evidence of breast cancer on mammogram within the past year
Hormone receptor status:
- For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
  - Must have had > 5% positive cells

PATIENT CHARACTERISTICS:

Age

40 to 70

Sex

Female

Menopausal status

Postmenopausal, defined as at least 1 of the following:
- Over 60 years of age
- Bilateral oophorectomy
- ≤ 60 years of age with a uterus and amenorrhea for at least 12 months
- ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels > 30 IU/L

Performance status

Not specified

Life expectancy

At least 10 years

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Psychologically and physically suitable to receive 5 years of anti-estrogen therapy
No cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No evidence of osteoporosis or fragility fractures within the spine
- Participants with a T-score > minus 4 and no more than 2 fragility fractures are allowed
No concurrent severe disease that would place the participant at unusual risk or confound the results of the study
No other medical condition that would preclude the ability to receive the study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) use for more than 3 months in duration
No concurrent tamoxifen, raloxifene, or other SERM
No concurrent estrogen-based hormone replacement therapy
No concurrent systemic estrogen replacement therapy, including vaginal estrogen preparations

Radiotherapy

Not specified

Surgery

See Disease Characteristics
No prior prophylactic mastectomy
No concurrent prophylactic mastectomy

Other

More than 3 months since prior investigational drugs
No prior participation in IBIS-I
No concurrent participation in IBIS-I

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078832

Show 113 Study Locations

Sponsors and Collaborators

Queen Mary University of London

International Breast Cancer Study Group

Investigators

Investigator:	Jack Cuzick, PhD	Cancer Research UK
Principal Investigator:	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

No publications provided

ClinicalTrials.gov Identifier:	NCT00078832 History of Changes
Other Study ID Numbers:	CDR0000353186, CRUK-IBIS-IIB, EU-20227, IBCSG-31-03-PREV, EUDRACT-2004-003991-12
Study First Received:	March 8, 2004
Last Updated:	December 6, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012