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Phase 3 N=2,980 Randomized Quadruple-blind Treatment

Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00072462 ↗
Enrolled (actual)
2,980
Serious AEs
24.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours — 103; 120 Participants — p=0.33

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
tamoxifen citrate (Drug); Anastrozole (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
Female
Sponsor
Queen Mary University of London
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours		 103; 120 0.33
SECONDARY
Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours		 58; 82 0.06
SECONDARY
Number of Participants With ER- Breast Cancer Recurrence		 24; 15 0.13
SECONDARY
Number of Breast Cancer Deaths		 3; 3 0.97
SECONDARY
Number of Non-breast Cancer Deaths		 59; 65 0.67

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00072462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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