Table 1.
Demographic characteristics of women at elevated risk for breast cancera, recruited from across the United States (N = 139) mean (SD) or N (%)
| Control | Low dose | High dose | All | |
|---|---|---|---|---|
| N | 46 | 45 | 48 | 139 |
| Age | 34.6 (7.47) | 35.2 (6.38) | 33.4 (6.76) | 34.35 (6.75) |
| Body mass index (kg/m2) | 26.8 (6.2) | 26.8 (6.0) | 26.7 (6.5) | 26.8 (6.2) |
| Race | ||||
| White | 39 (85 %) | 40 (89 %) | 39 (81 %) | 118 (85 %) |
| Black | 5 (11 %) | 4 (9 %) | 5 (11 %) | 14 (10 %) |
| Other | 2 (4 %) | 1 (2 %) | 4 (9 %) | 7 (5 %) |
| Ethnicity | ||||
| Hispanic | 3 (7 %) | 3 (7 %) | 4 (8 %) | 10 (7 %) |
| Education Level | ||||
| ≤HS | 3 (7 %) | 1 (2 %) | 0 (0 %) | 4 (3 %) |
| Some college | 12 (26 %) | 13 (29 %) | 15 (31 %) | 40 (29 %) |
| ≥College | 31 (67 %) | 31 (69 %) | 33 (69 %) | 95 (68 %) |
| Employed full time (% yes) | 24 (52 %) | 28 (62 %) | 28 (58 %) | 80 (58 %) |
| Marital status | ||||
| Single/divorced/separated | 23 (50 %) | 11 (24 %) | 21 (44 %) | 55 (40 %) |
| Married/partnered | 23 (50 %) | 34 (76 %) | 27 (56 %) | 84 (60 %) |
| Parity | ||||
| Nulliparous | 22 (48 %) | 12 (27 %) | 23 (48 %) | 51 (41 %) |
| Primaparous | 5 (11 %) | 5 (11 %) | 7 (15 %) | 17 (12 %) |
| Multiparous | 19 (41 %) | 28 (62 %) | 18 (38 %) | 65 (47 %) |
| Children (% yes) | 24 (52 %) | 34 (76 %) | 25 (52 %) | 83 (60 %) |
| BRCA gene mutation status | ||||
| Positive | 14 (32 %) | 18 (56 %) | 17 (37 %) | 49 (35 %)b |
| Negative | 7 (15 %) | 2 (4 %) | 3 (6 %) | 12 (9 %)c |
| Not tested | 25 (54 %) | 25 (56 %) | 28 (59 %) | 78c (56 %)d |
| Lifetime risk % for all (tested and non-tested) | ||||
| n = 27 | n = 24 | n = 18 | n = 69e | |
| Gail | 25.02 (10.25) | 21.45 (8.06) | 20.67 (5.89) | 22.65 (8.64) |
| n = 45 | n = 45 | n = 45 | n = 135f | |
| Claus | 24.09 (10.13) | 24.27 (10.05) | 25.13 (11.02) | 24.62 (10.34) |
Study eligibility required that all women not be taking any hormonal contraception or any other hormonal medications for specific time periods. For example: no oral contraceptives for 3 months, no depo-provera for 12 months, and no vaginal estrogen ring for 6 months. Women who stopped these medications to enter the study were required to show they had at least 3 menstrual cycles that fit our criteria of normal’ (25–32 days) before being admitted to the trial
49 participants tested positive for the BRCA1 or BRCA2 gene mutation. Those who tested positive were immediately deemed the appropriate risk level for the study
10 participants tested negative for both the BRCA1 and BRCA2 gene mutations. These participants were eligible for the study due to their lifetime risk, as calculated via the Gail and/or Claus models
78 participants were not tested for the BRCA1 and BRCA2 gene mutations. These participants were eligible for the study due to their lifetime risk, as calculated via the Gail and/or Claus models
A Gail score is not calculated for women below the age of 35, which is why the Gail N does not equal the total N randomized
A Claus score is not calculated for women who lack female first and/or second degree relatives with breast cancer, which is why the Claus N does not equal the total N randomized