Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention Active 40 to 70 Other CRUK-IBIS-IIB EU-20227, NCT00078832, IBCSG-31-03-PREV, EUDRACT-2004-003991-12

Objectives

Primary

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

Secondary

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

Entry 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

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

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

Expected Enrollment

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

Outcomes

Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years

Breast cancer mortality with median follow-up at 10 years

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

Trial Contact Information

Trial Lead Organizations

Queen Mary's University Hospital

Jack Cuzick, PhD, Study coordinator		Ph: 44-20-7269-3006

International Breast Cancer Study Group

Katharina Buser, MD, Principal investigator		Ph: 41-31-309-9501 Email: kbuser@sonnenhof.ch

Australia
New South Wales
	Campbelltown
	Cancer Therapy Centre at Campbelltown Hospital
		Contact Person	Ph:  61-2-4634-4355
	Coffs Harbour
	Coffs Harbour Health Campus
		Contact Person	Ph:  61-2 6656 7820
	Gateshead
	Breast Center
		Contact Person	Ph:  61-2-4942-2600
	Liverpool
	Cancer Therapy Centre at Liverpool Hospital
		Contact Person	Ph:  61-2-9828-5270
	Sydney
	St. Vincent's Hospital
		Contact Person	Ph:  61-2-8382-1111
	Wagga Wagga
	Riverina Cancer Care Centre
		Contact Person	Ph:  61-2-6925 4141
	Waratah
	Newcastle Mater Misericordiae Hospital
		Contact Person	Ph:  61-2-4921-1211
Queensland
	Nambour
	Nambour General Hospital
		Contact Person	Ph:  61-7-54-70-6600
South Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
		Contact Person	Ph:  61-88-222-4000
Victoria
	Box Hill
	Box Hill Hospital
		Contact Person	Ph:  61-3-9895-3333
	East Melbourne
	Breast Unit Mercy Private
		Contact Person	Ph:  61-3-9419-1166
	Peter MacCallum Cancer Centre
		Contact Person	Ph:  61-3-9656-1042
	East Ringwood
	Maroondah Hospital
		Contact Person	Ph:  61-3-9871-3582
	Fitzroy
	St. Vincent's Hospital - Melbourne
		Contact Person	Ph:  61-3-9288-2211
	Heidelberg
	Austin Hospital
		Contact Person	Ph:  61-3-9496-5000
	Parkville
	Royal Melbourne Hospital
		Contact Person	Ph:  61-3-9342-7000
Western Australia
	Perth
	Sir Charles Gairdner Hospital - Perth
		Contact Person	Ph:  61-8-9346-3841
Belgium
	Leuven
	U.Z. Gasthuisberg
		Contact Person	Ph:  32-16-34-3322-11
Chile
	Concepcion
	Clinica Sanatorio Aleman de Concepcion Edificio Centro
		Contact Person	Ph:  56-41-279-6430
	Penalolen
	Hospital Santiago Oriente Dr. Luis Tisne Brousse
		Contact Person	Ph:  56-2-472-5690
	Santiago
	Clinica Las Condes
		Contact Person	Ph:  56-2-210-4060
	Corporacion Nacional del Cancer
		Contact Person	Ph:  56-2-347-4000
	Fundacion Arturo Lopez Perez
		Contact Person	Ph:  56-2-420-5100
	Hospital Clinico San Borja Arriaran
		Contact Person	Ph:  56-2-544-6486
	Hospital Clinico Universidad de Chile
		Contact Person	Ph:  56-2-678-8000
	Hospital Militar
		Contact Person	Ph:  56-2-365-3517
	Instituto de Radiomedicina
		Contact Person	Ph:  56-2-754-1700
	Talcahuano
	Hospital Las Higueras
		Contact Person	Ph:  56-41-250-1575
	Temuco
	Hospital Regional de Temuco
		Contact Person	Ph:  56-45-296-537
	Valdivia
	Hospital Clinico Regional de Valdivia at University Austral de Chile
		Contact Person	Ph:  56-63-212-877
Denmark
	Horsholm
	Horsholm Sygenus
		Contact Person	Ph:  45-48-292-929
Finland
	Tampere
	Pirkanmaa Cancer Society
		Contact Person	Ph:  358-3-249-9111
Ireland
	Cork
	Cork University Hospital
		Contact Person	Ph:  353-21-492-2602
	South Infirmary Victoria Hospital
		Contact Person	Ph:  353-21-492-6100
	Dublin
	Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
		Contact Person	Ph:  353-1-414-2211
	Beaumont Hospital
		Contact Person	Ph:  353-1-809-3000
	Mater Misericordiae University Hospital
		Contact Person	Ph:  353-1-803-2000
	St. James's Hospital
		Contact Person	Ph:  353-1-410-3756
	St. Vincent's University Hospital
		Contact Person	Ph:  353-1-221-4000
	Galway
	University College Hospital
		Contact Person	Ph:  353-9-152-4390
	Limerick
	Mid-Western Cancer Centre at Mid-Western Regional Hospital
		Contact Person	Ph:  353-61-482-900
	Sligo
	Sligo General Hospital
		Contact Person	Ph:  353-71-917-4695
	Waterford
	Waterford Regional Hospital
		Contact Person	Ph:  353-51-848-000
Italy
	Bergamo
	Ospedali Riuniti di Bergamo
		Contact Person	Ph:  39-035-269-859
	Bolzano
	Azienda Sanitaria di Bolzano
		Contact Person	Ph:  39-471-908-111
	Brescia
	Spedali Civili di Brescia
		Contact Person	Ph:  39-030-395-823
	Carpi
	Ospedale Civile Ramazzini
		Contact Person	Ph:  39-059-659-111
	Coppito L'Aquila
	Universita Degli Studi de L'Aquila
		Contact Person	Ph:  39-0862-314-916
	Firenze
	Centro per lo Studio e la Prevenzione Oncologica
		Contact Person	Ph:  39-055-501-21
	Florence
	Azienda Ospedaliero Careggi
		Contact Person	Ph:  39-055-427-7111
	Floriana
	Sir Paul Boffa Hospital
		Contact Person	Ph:  39-356-2125-1412
	Lecco
	Ospedale Alessandro Manzoni
		Contact Person	Ph:  39-34-148-9100
	Milan
	European Institute of Oncology
		Contact Person	Ph:  39-02-5748-9861
	Modena
	Azienda Ospedaliera - Universitaria di Modena
		Contact Person	Ph:  39-059-422-4373
	Naples
	Istituto Nazionale per lo Studio e la Cura dei Tumori
		Contact Person	Ph:  39-81-590-3230
	Parma
	Ospedale Maggiore Parma
		Contact Person	Ph:  39-521-702-682
	Pavia
	Fondazione Salvatore Maugeri
		Contact Person	Ph:  39-0382-592-669
	Rimini
	Ospedale Civile Rimini
		Contact Person	Ph:  39-0541-705-567
	Turin
	Institute for Cancer Research and Treatment
		Contact Person	Ph:  39-011-993-3111
	Udine
	Policlinico Universitario Udine
		Contact Person	Ph:  39-0432-239-300
	Varese
	Ospedale di Circolo e Fondazione Macchi
		Contact Person	Ph:  39-0332-278-376
New Zealand
	Auckland
	North Shore Hospital
		Contact Person	Ph:  64-9-486-1491
	Christchurch
	Christchurch Hospital
		Contact Person	Ph:  64-3-364-0020
	Hamilton
	Waikato Hospital
		Contact Person	Ph:  64-7-839-8666
	Wellington
	Wellington Cancer Centre
		Contact Person	Ph:  64-4-385-5837
Peru
	Lima
	Instituto Nacional de Enfermedades Neoplasicas
		Contact Person	Ph:  51-1-612-9700
Portugal
	Angra do Heroismo
	Hospital Santo Espirito de Angra do Heroismo
		Contact Person	Ph:  351-295-403-200
	Lisbon
	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
		Contact Person	Ph:  351-21-722-9800
Switzerland
	Bern
	Inselspital Bern
		Manuela Rabaglio, MD	Ph:  41-31-632-4370
			Email: manuela.rabaglio@insel.ch
	International Breast Cancer Study Group
		Monica Castiglione-Gertsch, MD	Ph:  41-31-389-9391
			Email: monica.castiglione@ibcsg.org
	Oncocare Sonnenhof-Klinik Engeriedspital
		Katharina Buser, MD	Ph:  41-31-309-9501
			Email: kbuser@sonnenhof.ch
	Geneva
	Hopital Cantonal Universitaire de Geneve
		Herve Bonnefoi, MD	Ph:  41-22-382-3311
			Email: herve.bonnefoi@hcuge.ch
		Pierre Chappuis, MD	Ph:  41-22-372-9853
			Email: pierre.chappuis@hcuge.ch
	Mendrisio
	Ospedale Beata Vergine
		Olivia Pagani, MD	Ph:  41-91-811-3111
	Sion
	Institut Central des Hopitaux Valaisans
		Contact Person	Ph:  41-27-603-4786
	St. Gallen
	Tumor Zentrum ZeTup St. Gallen und Chur
		Senn Hans-Joerg, MD	Ph:  41-71-243-0043
			Email: hjsenn@sg.zetup.ch
	Thun
	Regionalspital
		Jean Marc Luthi, MD	Ph:  41-33-226-2626
United Kingdom
England
	Antrim
	Antrim Hospital
		Contact Person	Ph:  44-28-9442-4293
	Ashton-Under-Lyne
	Tameside General Hospital
		Contact Person	Ph:  44-161-331-6000
	Bournemouth
	Royal Bournemouth Hospital NHS Trust
		Contact Person	Ph:  44-202-303-626
	Bradford
	St. Luke's Hospital
		Contact Person	Ph:  44-1274-365-844
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Contact Person	Ph:  44-12-7369-6955