Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ (IBIS-II DCIS)
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| ClinicalTrials.gov Identifier: NCT00072462 |
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Recruitment Status :
Completed
First Posted : November 6, 2003
Last Update Posted : October 6, 2021
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: tamoxifen citrate Drug: Anastrozole | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2980 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | International Breast Cancer Intervention Study II (IBIS-II) (DCIS) |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | May 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years [ Time Frame: 2 years ]
- To examine the effect of tamoxifen vs anastrozole on breast cancer mortality [ Time Frame: 7 years ]
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Diagnosis of ductal carcinoma in situ within the past 6 months
- Locally excised with tumor-free margins at least 1 mm
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Hormone receptor status:
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Estrogen or progesterone receptor positive
- Equal to or greater than 5% positive cells
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PATIENT CHARACTERISTICS:
Age
- 40 to 70
Sex
- Female
Menopausal status
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072462
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| Study Chair: | Jack Cuzick, PhD | Queen Mary University of London | |
| Study Chair: | Anthony Howell | University of Manchester |
Publications:
| Responsible Party: | Queen Mary University of London |
| ClinicalTrials.gov Identifier: | NCT00072462 |
| Other Study ID Numbers: |
ISRCTN37546358 EU-20226 BIG-5-02 IBCSG-31-03-DCIS ISRCTN31488319 |
| First Posted: | November 6, 2003 Key Record Dates |
| Last Update Posted: | October 6, 2021 |
| Last Verified: | September 2021 |
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ductal breast carcinoma in situ breast cancer in situ |
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Breast Neoplasms Carcinoma in Situ Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Tamoxifen Anastrozole Molecular Mechanisms of Pharmacological Action |
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 |