Study of Tamoxifen and Raloxifene STAR

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Study of Tamoxifen and RaloxifeneSTAR

• Larry Wickerham, MD
• NSABP STAR Project Officer

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NSABP P1 Study
Invasive Breast Cancer
Noninvasive Breast Cancer
50
Events Placebo 250 Tamoxifen 14
5
Events Placebo 93 Tamoxifen 60

40
30
Cumulative Rate/1000
P 0.008
20
P lt 0.0001
10
0
Time to Breast Cancer (Years)
3
Study DesignSTAR
Risk-Eligible Postmenopausal Women

• STRATIFICATION
• Age
• Gail Model Risk
• Race
• History of LCIS
• Hysterectomy

Tamoxifen 20 mg/day x 5 years
Raloxifene 60 mg/day x 5 years
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Inclusion and Exclusion CriteriaSTAR

• Inclusion
• At least 35 years of age
• Postmenopausal
• Risk eligible
• Lobular carcinoma in situ or
• 5-year Gail risk of breast cancer gt1.66

• Exclusion
• History of
• Invasive breast cancer
• Ductal carcinoma in situ
• DVT, PE
• CVA, TIA
• Uncontrolled diabetes, hypertension or atrial
  fibrillation

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Primary AimsSTAR

• The primary aim of the study was to determine
  which of the following three statements is true
• Compared to tamoxifen, raloxifene significantly
  reduces the incidence rate of IBC
• Compared to raloxifene, tamoxifen significantly
  reduces the incidence rate of IBC
• The statistical superiority of one of the
  treatments cannot be demonstrated and the choice
  of therapy should be based on benefit/risk
  considerations

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Primary ObjectiveSTAR

• Evaluate the effect of raloxifene versus
  tamoxifen in reducing the incidence of invasive
  breast cancer in postmenopausal women who are at
  increased risk.

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Secondary Objectives STAR

• Non-invasive breast cancer
• Endometrial cancer
• Ischemic heart disease
• Fractures of the hip, spine or wrist
• Toxicity and side effects

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Screening, Accrual and Follow-upSTAR

• Screened 184,460
• Eligible 96,368
• Randomized 19,747
• Woman-years of follow-up 79,173
• Average follow-up (years) 4.06

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Baseline CharacteristicsSTAR

• Age (mean) 58.5
• Caucasian 93
• Hysterectomy 51
• First degree relative(s)with breast cancer 71
• History of
• Lobular carcinoma in situ 9
• Atypical hyperplasia 23
• 5-year predicted Gail risk ofinvasive breast
  cancer (mean) 4.03

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Effects on Invasive Breast Cancer STAR
RR (95 CI) 1.02 (0.82, 1.27)
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Invasive Breast Cancer STAR
325
173
168
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Invasive Breast Cancer by 5-year Predicted
RiskSTAR
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Invasive Breast Cancer Tumor CharacteristicsSTAR
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Invasive Breast Cancer in Women with aHistory of
LCIS or Atypical Hyperplasia STAR
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Non-Invasive Breast Cancer STAR
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Non-Invasive Breast CancerSTAR
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Uterine Cancer STAR
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Uterine Hyperplasia and HysterectomySTAR
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Ischemic Heart Disease STAR
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Osteoporotic Fractures STAR
Columns not additive because one patient may
have had fractures at multiple sites.
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MortalitySTAR
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Venous Thromboembolic EventsSTAR
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Cataracts and Cataract Surgery During
Follow-upSTAR
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Summary STAR

• Compared with tamoxifen, raloxifene was
• similar in decreasing the risk of invasive breast
  cancer
• not as effective at decreasing the risk of
  non-invasive breast cancer
• associated with fewer
• adverse events related to uterus
• VTEs
• cataracts and cataract surgery