Table 1 Patient characteristics in the clinical trial
Total (n = 81) | Continuous (Arm 1; n = 41) | Intermittent (Arm 2; n = 40) | p value | |
|---|---|---|---|---|
Age at randomization, years (range) | 54 (34–75) | 53 (49–62) | 55 (47–61) | 0.53 |
Age group ≤ 50 | 27 (33%) | 12 (29%) | 15 (38%) | 0.43 |
Sex | ||||
Female | 81 (100%) | 41 (100%) | 40 (100%) | |
Male | 0 (0%) | 0 (0%) | 0 (0%) | |
Menopausal status | 0.59 | |||
Pre- or perimenopausal | 30 (37%) | 14 (34%) | 16 (40%) | |
Postmenopausal | 51 (63%) | 27 (66%) | 24 (60%) | |
Race | 0.32 | |||
Asian | 4 (5%) | 3 (7%) | 1 (2%) | |
Black or African American | 3 (4%) | 0 (0%) | 3 (8%) | |
More than one race | 3 (4%) | 1 (2%) | 2 (5%) | |
Other or unknown | 7 (9%) | 3 (7%) | 4 (10%) | |
White | 64 (79%) | 34 (83%) | 30 (75%) | |
Ethnicity | 0.24 | |||
Hispanic or Latino | 5 (6%) | 2 (5%) | 3 (8%) | |
Non-Hispanic | 63 (78%) | 35 (85%) | 28 (70%) | |
Unknown | 13 (16%) | 4 (10%) | 9 (22%) | |
Disease stage | 0.93 | |||
I | 11 (14%) | 6 (15%) | 5 (12%) | |
II | 45 (56%) | 23 (56%) | 22 (55%) | |
III | 25 (31%) | 12 (29%) | 13 (32%) | |
Histological grade | 0.23 | |||
1 | 11 (14%) | 8 (20%) | 3 (8%) | |
2 | 46 (57%) | 23 (56%) | 23 (57%) | |
3 | 24 (30%) | 10 (24%) | 14 (35%) | |
Estrogen receptor-positive | 81 (100%) | 41 (100%) | 40 (100%) | |
Progesterone receptor status | 0.25 | |||
Low positive | 1 (1%) | 1 (2%) | 0 (0%) | |
Positive | 71 (88%) | 37 (90%) | 34 (85%) | |
Negative | 8 (10%) | 2 (5%) | 6 (15%) | |
Unknown | 1 (1%) | 1 (2%) | 0 (0%) | |
Surgery | 0.71 | |||
Bilateral mastectomy | 26 (32%) | 13 (32%) | 13 (32%) | |
Unilateral mastectomy | 29 (36%) | 14 (34%) | 15 (38%) | |
Lumpectomy or conservation | 25 (31%) | 14 (34%) | 11 (28%) | |
None | 1 (1%) | 0 (0%) | 1 (2%) | |
Radiotherapy | 0.97 | |||
Adjuvant | 71 (88%) | 36 (88%) | 35 (88%) | |
None | 10 (12%) | 5 (12%) | 5 (12%) | |
Chemotherapy (general) | 0.75 | |||
Adjuvant or neoadjuvant | 62 (77%) | 32 (78%) | 30 (75%) | |
None | 19 (23%) | 9 (22%) | 10 (25%) | |
Anthracycline therapy | 0.32 | |||
Yes | 46 (57%) | 23 (56%) | 23 (57%) | |
No | 33 (41%) | 18 (44%) | 15 (38%) | |
Unknown | 2 (2%) | 0 (0%) | 2 (5%) | |
Taxane therapy | 0.56 | |||
Yes | 61 (75%) | 32 (78%) | 29 (72%) | |
No | 20 (25%) | 9 (22%) | 11 (28%) | |
Initial adjuvant endocrine therapy | 0.04 | |||
Aromatase inhibitor | 63 (78%) | 28 (68%) | 35 (88%) | |
Tamoxifen | 18 (22%) | 13 (32%) | 5 (12%) | |
Concurrent adjuvant LHRH agonist | 0.59 | |||
Yes | 30 (37%) | 14 (34%) | 16 (40%) | |
No | 51 (63%) | 27 (66%) | 24 (60%) | |
Duration of endocrine therapy (prior to randomization) | 0.06 | |||
< 2 years | 53 (65%) | 23 (56%) | 30 (75%) | |
2–5 years | 20 (25%) | 11 (27%) | 9 (22%) | |
> 5 years | 8 (10%) | 7 (17%) | 1 (2%) | |
