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:
Jill Knox
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Jill Knox, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT00072462
First received: November 4, 2003
Last updated: May 15, 2012
Last verified: May 2012
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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: | June 2013 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072462
Show 112 Study Locations
Show 112 Study LocationsSponsors and Collaborators
Jill Knox
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: | Jill Knox, Clinical Project Manager, 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: | May 15, 2012 |
| 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 Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Tamoxifen Anastrozole |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013