Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003649

Trial Description

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Title

International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

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Trial Acronym

IBIS-II DCIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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, multicentre study. Patients are stratified
according to participating centre. 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 and a further 5 years off treatment.

Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London

ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.

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Organizational Data

  •   DRKS00003649
  •   2012/05/04
  •   2003/11/04
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT00072462  (ClinicalTrials.gov)
  •   ISRCTN37546358  (Jill Knox)
  •   EU-20226 
  •   BIG-5-02 
  •   IBCSG-31-03-DCIS 
  •   ISRCTN31488319 
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: tamoxifen citrate
  •   Drug: Anastrozole
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
  •   [---]*
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Primary Outcome

- Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years; time frame: 2 years

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Secondary Outcome

- To examine the effect of tamoxifen vs anastrozole on breast cancer mortality; time frame: 7 years

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Countries of Recruitment

  •   Australia
  •   Austria
  •   Belgium
  •   Chile
  •   France
  •   Germany
  •   Hungary
  •   Ireland
  •   Italy
  •   Malta
  •   Sweden
  •   Switzerland
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2003/09/30
  •   2980
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   40   Years
  •   70   Years
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Additional Inclusion 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

- Equal to or 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 6 months unless treatment was
completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for
at least 5 years.

- No prior or concurrent raloxifene use lasting more than 6 months unless treatment was
completed more than 5 years ago.

- No other prior or concurrent selective estrogen-receptor modulator use lasting more
than 6 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

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Jill Knox
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    • Cancer Prevention Trials Unit, Queen Mary University of London
    • Jack Cuzick, PhD 
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    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Cancer Prevention Trials Unit, Queen Mary University of London
    • Jack Cuzick, PhD 
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    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Clinical trial summary from the National Cancer Institute's PDQ® database
  •   IBIS-II website
  •   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.; 18816321
  •   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.; 18768369
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.