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3.1
Required characteristics
3.11 Female age =18 years.
3.12
History of breast cancer (history of dcis or lcis acceptable;
currently without malignant disease); TAM and raloxifene
are allowed if started =4 weeks prior to registration and
the plan is to continue throughout the study.
3.13
Bothersome hot flashes (defined by their occurrence at least
14 times per week and of sufficient severity to make the
patient desire therapeutic intervention).
3.14
Presence of hot flashes for at least one month prior to
study entry.
3.15
Life expectancy =6 months. 3.16 ECOG PS 0-1.
3.2
Contraindications
3.21
Any of the following current (=4 weeks) or planned therapies:
- Antineoplastic
chemotherapy;
- Androgens;
- Estrogens;
- Progestational
agents, and
- Corticosteroids.
3.22
History of allergic reaction to soy products.
3.23
Regular use (more than once per week) of phytoestrogen pills,
soy milk or soy products such as tofu. However, the patient
would be eligible if these products are stopped for seven
days prior to registration.
3.24
Current or planned use of other agents for treating hot
flashes (megestrol acetate, clonidine, Bellergal-s, vitamin
E, etc.).
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