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Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ (IBIS-II DCIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00072462
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Queen Mary University of London

Tracking Information
First Submitted Date  ICMJE November 4, 2003
First Posted Date  ICMJE November 6, 2003
Last Update Posted Date October 6, 2021
Study Start Date  ICMJE September 2003
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
To examine the effect of tamoxifen vs anastrozole on breast cancer mortality [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Official Title  ICMJE International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
Brief Summary

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.

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, 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 (minimum) 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: tamoxifen citrate
    Tamoxifen 20mg + Anastrozole placebo
    Other Name: Nolvadex
  • Drug: Anastrozole
    Anastrozole 1mg + Tamoxifen placebo
    Other Name: Arimidex
Study Arms  ICMJE
  • Active Comparator: Anastrozole
    Intervention: Drug: Anastrozole
  • Active Comparator: Tamoxifen
    Intervention: Drug: tamoxifen citrate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2012)
2980
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Chile,   France,   Germany,   Hungary,   Ireland,   Italy,   Malta,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Finland
 
Administrative Information
NCT Number  ICMJE NCT00072462
Other Study ID Numbers  ICMJE ISRCTN37546358
EU-20226
BIG-5-02
IBCSG-31-03-DCIS
ISRCTN31488319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Queen Mary University of London
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE
Study Chair: Jack Cuzick, PhD Queen Mary University of London
Study Chair: Anthony Howell University of Manchester
PRS Account Queen Mary University of London
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP