Clinical trial NCT00096369 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: tamoxifen citrate
SMILES: COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Reason stopped: 
    accrual goal not met
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  At increased risk for breast cancer, as defined by 1 of the following criteria:

               -  Histologically confirmed lobular carcinoma in situ (LCIS) treated by local
                  excision only

               -  Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the
                  following criteria:

                    -  Age

                    -  Number of first-degree female relatives with breast cancer

                    -  One or more prior breast biopsies

                         -  Fine-needle aspiration cytology of a non-cystic lesion in lieu of an
                            open biopsy is considered a biopsy

                    -  Prior diagnosis of atypical hyperplasia of the breast

                    -  Age at first live birth

                    -  Nulliparity

                    -  Race

                    -  Age at onset of menarche

          -  No prior or suspected invasive breast cancer or ductal carcinoma in situ

          -  No clinical evidence of malignancy by physical examination, including a breast
             examination within the past 3 months

          -  No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral
             mammogram within the past 6 months

          -  Normal gynecologic examination, including a bimanual pelvic examination and, if
             indicated, pap smear within the past 12 months

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  35 and over

        Sex

          -  Female

        Menopausal status

          -  Premenopausal and ovulating*, defined as having regular menses for the past 6 months
             OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone
             level < 20 mIU/mL OR

          -  Postmenopausal NOTE: * Ovulation is determined by day 21 progesterone level > 3 ng/mL

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Complete blood count normal

          -  No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality,
             hemophilia, or von Willebrand's disease)

        Hepatic

          -  Liver function tests normal

        Renal

          -  Not specified

        Cardiovascular

          -  No prior deep-vein thrombosis except a single occurrence related to lower extremity
             trauma

          -  No prior cerebral vascular accident

          -  No prior transient ischemic attack

        Pulmonary

          -  No prior pulmonary embolus except a single occurrence related to lower extremity
             trauma

        Other

          -  No saline or silicone breast implants

          -  No known allergy to tamoxifen

          -  No macular degeneration

          -  No malignancy within the past 5 years except basal cell or squamous cell skin cancer
             or carcinoma in situ of the cervix

          -  No nonmalignant disease that would preclude administration of tamoxifen

          -  No psychiatric condition, including a history of clinical depression or addictive
             disorder, that would preclude giving informed consent or study compliance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception during and for 3 months
             after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior systemic adjuvant chemotherapy for LCIS

        Endocrine therapy

          -  No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators

          -  At least 3 months since prior and no concurrent use of any of the following drugs:

               -  Estrogen or progesterone replacement therapy

               -  Oral contraceptives

               -  Androgens

               -  Luteinizing hormone-releasing hormone analogs

               -  Prolactin inhibitors

               -  Antiandrogens

               -  Steroids

          -  No concurrent steroids for asthma

        Radiotherapy

          -  No prior radiotherapy for LCIS

        Surgery

          -  No prior bilateral prophylactic mastectomy

          -  No prior mastectomy for LCIS

        Other

          -  Concurrent nonhormonal medications allowed

          -  No concurrent warfarin or cholestyramine

          -  No prior or concurrent participation in any other cancer prevention study

               -  Patients treated with placebo on protocol NSABP-P-1 are eligible