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 2 weeks prior to randomization)Xx_NEWLINE_xXPregnancy or lactation at the time of study entry; (Note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation or unwillingness to use adequate method of birth control.Xx_NEWLINE_xXCurrent pregnancy or lactationXx_NEWLINE_xXPregnancy (independent of outcome) and/or lactation within 1 year prior to the screening mammogram.Xx_NEWLINE_xXPregnancy, lactation, or breastfeeding women.Xx_NEWLINE_xXPregnancy (positive serum pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXCurrent lactationXx_NEWLINE_xXGENERAL: Pregnancy, lactation, or breastfeeding.Xx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy, lactation, or breastfeeding.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPatients who are pregnant, are lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPatients may not have significant concurrent illness, infection, pregnancy or lactationXx_NEWLINE_xXPregnancy and lactation; refusal to use adequate contraceptionXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXCurrent pregnancy or lactationXx_NEWLINE_xXTREATMENT: Pregnancy or lactationXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy and lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation at enrollmentXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactation.Xx_NEWLINE_xXConfirmed or suspected pregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeeding.Xx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactation at the time of study entry (note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactation at the time of study entry; (note: pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy (due to unknown effects of this therapy on a fetus) or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or inability or unwillingness to use medically acceptable forms of contraception if pregnancy is a risk.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactation at the time of study entry.Xx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactation periodXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXEvidence of pregnancy or lactation periodXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXEvidence of pregnancy or lactation period.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy and lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation; patients of child bearing age must agree to use adequate contraceptionXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactation at the time of registrationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXFor female participants, current pregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy and/or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXCurrent pregnancy or lactationXx_NEWLINE_xXPregnancy (positive pregnancy test) or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xXLactationXx_NEWLINE_xXStage I Arm A: Pregnancy, lactation, or intention to become pregnant or fathering a child during the studyXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXMust be > 1 year from pregnancy, lactation or chemotherapyXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactation within the prior 6 monthsXx_NEWLINE_xXMust be more than 1 year from pregnancy, lactation or chemotherapyXx_NEWLINE_xXPregnancy or lactation.Xx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXGreater than 1 year from pregnancy, lactationXx_NEWLINE_xXPregnancy or lactation (by history) or positive pregnancy test at screening visitXx_NEWLINE_xXHave experienced lactation or pregnancy during the previous 12 monthsXx_NEWLINE_xXMust be > 1 year from pregnancy, lactation or chemotherapyXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXLactation if the patient is receiving radiation therapyXx_NEWLINE_xXPregnancy and lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXWomen only: pregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy or lactationXx_NEWLINE_xXPregnancy, lactation, or breastfeedingXx_NEWLINE_xX