Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study; Women of child-bearing potential is defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for  weeks after study drug discontinuation. Highly effective contraception methods include:\r\n* Total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Combination of any of the two following\r\n** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < %), for example hormone vaginal ring or transdermal hormone contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction; in case of use of oral contraception, women should have been stable on the same pill for a minimum of  months before taking study treatment
Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through  days after the last dose of study drug unless patient is practicing true abstinence; acceptable forms of effective contraception include:\r\n* Oral, injected or implanted hormonal methods of contraception\r\n* Tubal ligation\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n* Male sterilization (defined as complete retrograde ejaculation or the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Combination of any of the two following (a+b or a+c or b+c): a) use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < %), for example hormone vaginal ring or transdermal hormone contraception; b) placement of an intrauterine device (IUD) or intrauterine system (IUS); c) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository. In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception; adequate contraception is defined as:\r\n* Total abstinence or\r\n* Male or female sterilization or\r\n* Combination of any two of the following:\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
Premenopausal patients must agree to use adequate contraception for the duration of protocol treatment and for  months after the last treatment with palbociclib; adequate contraception is defined as one highly effective form (i.e. abstinence, male or female sterilization) OR two effective forms (e.g. non-hormonal intrauterine device [IUD] and condom/occlusive cap with spermicidal foam/gel/film/cream/suppository); hormonal contraceptive methods are not allowed; patients with hormonal IUD in place are eligible provided the hormonal IUD is removed or replaced by a non-hormonal IUD prior to treatment initiation
Combination of any of the two following\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < %), for example hormone vaginal ring or transdermal hormone contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; in case of use of oral contraception, women should have been stable on the same pill before taking study treatment; note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception
Female subjects contraception methods: a) abstinence; b) intrauterine device (IUD) or intrauterine system (IUS) that meets the < % failure rate as stated in the product label; c) male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; d) double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
Female patients of childbearing potential and male patients with partners of childbearing potential who are not willing to use highly effective methods of contraception throughout the study and for  month after study drug discontinuation; highly effective contraception methods include: \r\n* Total abstinence or \r\n* Male or female sterilization \r\n* Combination of any two of the following: \r\n** Use of oral, injected, or implanted hormonal methods of contraception \r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
One of the following is required: i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through  days after the last dose of study drug; acceptable forms of effective contraception include:\r\n* Oral, injected or implanted hormonal methods of contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n* Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* True abstinence: When this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit; a positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic ultrasound (US); a pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for  months after stopping study drug; highly effective contraception methods include:\r\n* Total abstinence or\r\n* Male or female sterilization or\r\n* Combination of any two of the following (a+b or a+c or b+c):\r\n** Use of oral, injected or implanted hormonal methods of contraception\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
If, for any reason, a woman should become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately; women who are made postmenopausal through use of GNRH agonists, and men are required to use adequate contraception for the duration of protocol treatment and for  months after the last dose of palbociclib and bazedoxifene; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner\r\n* Highly Effective Non-Hormonal Contraception\r\n* Methods of birth control which result in a low failure rate (i.e., less than % per year) when used consistently and correctly are considered highly-effective forms of contraception; the following non-hormonal methods of contraception are acceptable:\r\n** True abstinence when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female patients, the vasectomized male partner should be the sole partner OR\r\n* Effective Non-Hormonal Contraception: Alternatively two of the following effective forms of contraception may be used instead:\r\n** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n** Condom with spermicidal foam/gel/film/cream/suppository\r\n** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; the use of barrier contraceptives should always be supplemented with the use of spermicide\r\n* The following should be noted:\r\n** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone; It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/ vault caps) with spermicidal foam/gel/film/cream /suppository; premenopausal women who have been on a GnRH agonist for at least  consecutive months prior to study entry are eligible; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment; such patients should be counseled that GnRH agonists alone may not be adequate contraception and that adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation should be employed
Male patients whose sexual partner(s) are women of child-bearing potential (WOCBP) who are not willing to use adequate contraception, during the study and for  weeks after the end of treatment; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
If, for any reason, a woman should become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately; women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men are required to use adequate contraception for the duration of protocol treatment and for  months after the last dose of palbociclib; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner\r\n* Highly Effective Non-Hormonal Contraception; methods of birth control which result in a low failure rate (i.e., less than % per year) when used consistently and correctly are considered highly-effective forms of contraception\r\n* The following non-hormonal methods of contraception are acceptable:\r\n** True abstinence when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female patients, the vasectomized male partner should be the sole partner OR\r\n* Effective Non-Hormonal Contraception; alternatively two of the following effective forms of contraception may be used instead:\r\n** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n** Condom with spermicidal foam/gel/film/cream/suppository\r\n** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; the use of barrier contraceptives should always be supplemented with the use of spermicide; the following should be noted:\r\n*** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception; therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n*** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone\r\n* It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream /suppository
Combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < %), for example hormone vaginal ring or transdermal hormone contraception\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository \r\n** In case of use of oral contraception women should have been stable on the same pill for a minimum of  months before taking study treatment
Male sterilization (at least  months prior to screening). For female patients on the study, study participation assumes the vasectomized male partner is the sole partner for that patient or b. A combination of any two of the following (i+ii or i+iii or ii+iii): i) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository ii) Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <%), for example hormone vaginal ring or transdermal hormone contraception iii) Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least  days after the last dose of palbociclib if the risk of contraception exists; adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner\r\n* Highly effective non-hormonal contraception\r\n** Methods of birth control which result in a low failure rate (i.e., less than % per year) when used consistently and correctly are considered highly-effective forms of contraception\r\n** The following non-hormonal methods of contraception are acceptable:\r\n*** True abstinence when this is in line with the preferred and usual lifestyle of the participant; (periodic abstinence [e.g., calendar, ovulation, symptothermal post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n*** Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); for female participants, the vasectomized male partner should be the sole partner OR\r\n* Effective non-hormonal contraception\r\n** Alternatively two of the following effective forms of contraception may be used instead:\r\n*** Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS); consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire\r\n*** Condom with spermicidal foam/gel/film/cream/suppository\r\n*** Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n*** The use of barrier contraceptives should always be supplemented with the use of spermicide; the following should be noted:\r\n**** Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception; therefore, the use of additional spermicides does confer additional theoretical contraceptive protection\r\n**** However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled; therefore, spermicides are not a barrier method of contraception and should not be used alone\r\n* It should be noted that two forms of effective contraception are required; a double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least  months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to use highly effective methods of contraception during the study and  weeks after; highly effective contraception methods include combination of any two of the following: \r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
For female patients on the study, the vasectomized male partner should be the sole partner for that patient; combination of any of the two following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < %), for example hormone vaginal ring or transdermal hormone contraception \r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS) \r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n** In case of use of oral contraception, women should have been stable on the same pill before taking study treatment; Note: oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and  weeks after; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
Highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
Pregnant women, nursing mothers and women of childbearing potential not using contraception known to be highly effective; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;\r\n* Total abstinence;\r\n* Male/female sterilization
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and  weeks after; highly effective contraception methods include combination of any two of the following: \r\n* Use of oral, injected or implanted hormonal methods of contraception or\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository\r\n* Total abstinence or\r\n* Male/female sterilization
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and  weeks after; highly effective contraception methods include combination of any two of the following:\r\n* Use of oral, injected or implanted hormonal methods of contraception, or;\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS);\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;\r\n* Total abstinence or;\r\n* Male/female sterilization
Heterosexually active males and their partners of childbearing potential must agree or use at least  forms of highly effective methods of contraception, including at least  barrier method. Highly effective methods of contraception are those that, alone or in combination, result in a failure rate of <% per year when used consistently and correctly (i.e., perfect use). Contraception must include male condom or female condom used with a spermicide (i.e., foam, gel, film, cream, suppository) as well as established use of oral, injected or implanted hormonal methods of contraception, correctly placed intrauterine device or intrauterine system.