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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00072462
First received: November 4, 2003
Last updated: August 21, 2015
Last verified: August 2015
  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: tamoxifen citrate
Drug: Anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: International Breast Cancer Intervention Study II (IBIS-II) (DCIS)

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of tamoxifen vs anastrozole on breast cancer mortality [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Enrollment: 2980
Study Start Date: September 2003
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anastrozole Drug: Anastrozole
Anastrozole 1mg + Tamoxifen placebo
Other Name: Arimidex
Active Comparator: Tamoxifen Drug: tamoxifen citrate
Tamoxifen 20mg + Anastrozole placebo
Other Name: Nolvadex

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 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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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

      • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 112 Study Locations
Sponsors and Collaborators
Queen Mary University of London
Cancer Research UK
Investigators
Study Chair: Jack Cuzick, PhD Cancer Prevention Trials Unit, Queen Mary University of London
  More Information

Additional Information:
Publications:
Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT00072462     History of Changes
Other Study ID Numbers: ISRCTN37546358  EU-20226  BIG-5-02  IBCSG-31-03-DCIS  ISRCTN31488319 
Study First Received: November 4, 2003
Last Updated: August 21, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tamoxifen
Anastrozole
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016