Pregnancy or lactation at the time of study entry; (note: pregnancy testing according to institutional standards for women of childbearing potential must be performed within weeks prior to randomization) Pregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within weeks prior to randomization according to institutional standards for women of childbearing potential) Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation Pregnancy or lactation Current pregnancy or lactation Pregnancy (independent of outcome) and/or lactation within year prior to the screening mammogram. Pregnancy, lactation, or breastfeeding women. Pregnancy (positive serum pregnancy test) or lactation Pregnancy or lactation. Current lactation GENERAL: Pregnancy, lactation, or breastfeeding. Pregnancy or lactation. Pregnancy, lactation, or breastfeeding. Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation. Pregnancy, lactation, or breastfeeding Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation. Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy, lactation, or breastfeeding Patients who are pregnant, are lactation, or breastfeeding Pregnancy or lactation Pregnancy or lactation Patients may not have significant concurrent illness, infection, pregnancy or lactation Pregnancy and lactation; refusal to use adequate contraception Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Current pregnancy or lactation TREATMENT: Pregnancy or lactation Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy and lactation Pregnancy or lactation Pregnancy or lactation at enrollment Pregnancy or lactation. Pregnancy or lactation Pregnancy (positive pregnancy test) or lactation. Confirmed or suspected pregnancy or lactation Pregnancy, lactation, or breastfeeding. Pregnancy, lactation, or breastfeeding Pregnancy or lactation at the time of study entry (note: pregnancy testing must be performed within weeks prior to randomization according to institutional standards for women of childbearing potential) Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation at the time of study entry; (note: pregnancy testing must be performed within weeks prior to randomization according to institutional standards for women of childbearing potential) Pregnancy or lactation Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within days prior to randomization according to institutional standards for women of childbearing potential.) Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy (due to unknown effects of this therapy on a fetus) or lactation Pregnancy or lactation Pregnancy, lactation, or inability or unwillingness to use medically acceptable forms of contraception if pregnancy is a risk. Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation. Pregnancy or lactation at the time of study entry. Pregnancy, lactation, or breastfeeding Pregnancy or lactation period Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation. Pregnancy or lactation Evidence of pregnancy or lactation period Pregnancy or lactation. Evidence of pregnancy or lactation period. Pregnancy or lactation Pregnancy or lactation. Pregnancy, lactation, or breastfeeding Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy and lactation Pregnancy or lactation Pregnancy or lactation Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation at the time of registration Pregnancy, lactation, or breastfeeding Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy, lactation, or breastfeeding Pregnancy or lactation For female participants, current pregnancy or lactation Pregnancy or lactation Pregnancy or lactation. Pregnancy, lactation, or breastfeeding Pregnancy and/or lactation Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation. Current pregnancy or lactation Pregnancy (positive pregnancy test) or lactation Pregnancy or lactation Pregnancy or lactation. Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy, lactation or breastfeeding Pregnancy or lactation Pregnancy, lactation, or breastfeeding Pregnancy or lactation Pregnancy, lactation, or breastfeeding Lactation Pregnancy or lactation Must be > year from pregnancy, lactation or chemotherapy Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation within the prior months Must be more than year from pregnancy, lactation or chemotherapy Pregnancy or lactation. Pregnancy or lactation Pregnancy or lactation Greater than year from pregnancy, lactation Pregnancy or lactation (by history) or positive pregnancy test at screening visit Have experienced lactation or pregnancy during the previous months Must be > year from pregnancy, lactation or chemotherapy Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Lactation if the patient is receiving radiation therapy Pregnancy and lactation Pregnancy or lactation Women only: pregnancy or lactation Pregnancy or lactation Pregnancy or lactation Pregnancy, lactation, or breastfeeding