Patients with hormone receptor positive breast cancer as defined above must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression; (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required); hormonal therapy can be initiated prior to or during protocol therapy
Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Prior malignancy is allowed providing it does not require concurrent therapy\r\n* Exception: active hormonal therapy is allowed
hormonal therapy
one prior hormonal therapy and one prior chemotherapy regimen; or
Subject must not have had more than 24 months of hormonal therapy in combination with prostatectomy or radiation in the setting of localized disease and must not have shown any evidence of disease recurrence within 12 months after stopping hormonal therapy; disease recurrence after hormonal therapy is defined as PSA > 0.2 ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0 ng/dl more than the PSA nadir after radiotherapy + hormonal therapy; previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment
Patients who are actively receiving any other anticancer therapy except for hormonal therapy for well-controlled breast or prostate cancer
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and greater than 6 months before entry is acceptable)
Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), or any systemic corticosteroid, must discontinue the agent for at least four weeks prior to ipilimumab treatment; progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist)
Subjects on bisphosphonates/denosumab for any cancer or on hormone therapy for prostate cancer may continue this therapy; however, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy or refused or is intolerant of hormonal therapy
Hormonal therapy during the study or within 2 weeks of first study enrollment
Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil are not eligible
If patient has already started hormonal blockade therapy after radiation as adjuvant therapy, patient is eligible as long as the hormonal therapy was initiated no more than 6 months by the time of screening and can start the study drug within 4 weeks since the completion of screening.
Any hormonal therapy being taken as a treatment for cancer must be discontinued at least one week prior to registration; continuation of hormone replacement therapy e.g. thyroid hormone replacement therapy is permitted
Participant may have received prior hormonal therapy
Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for prostate cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.
Patients who concurrently use hormonal therapy and/or concurrent radiation therapy
No prior chemotherapy in the recurrent setting; prior hormonal therapy is permitted; concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment; low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given
Ongoing treatment with hormonal agents (e.g. finasteride, dutasteride, ketoconazole, hormonal birth control, estrogen replacement therapy, testosterone replacement therapy) or herbal products that may have hormonal activity (saw palmetto, black cohosh); patients taking these agents are eligible for screening, but must be willing to undergo a washout period of 4 weeks prior to starting study treatment
Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
No plan to treat with adjuvant hormonal or radiation therapy
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
Hormonal therapy within 2 weeks before the first dose of study treatment
Hormonal therapy within 1 week
Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment; patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study
Patients must be >= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =< grade 1 or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field; patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks (wks), whichever is shorter, from the last day of treatment; continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian, or breast cancer are not exclusionary
Patients may have received prior hormonal therapy; the hormonal treatment must have been discontinued for > 6 months prior to study entry
Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug
Hormonal therapies acting on the hypothalamic-pituitary-gonadal axis (i.e., LHRH agonist/antagonist) are permitted. No other hormonal therapy is permitted;
Patients receiving any systemic chemotherapy, hormonal therapy or radiotherapy.
Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least 4 weeks prior to registration
Timing of prior therapy:\r\n* Prior hormonal therapy is allowed; hormonal therapy must be discontinued at least 7 days before initiation of protocol therapy\r\n* Ovarian suppression which has been used for > 6 months, during which time there has been disease progression, is allowed concurrently with protocol-based therapy; other hormonal agents (e.g. tamoxifen, aromatase inhibitors, fulvestrant) should be discontinued prior to study entry\r\n* If received, chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry\r\n* Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment\r\n* Patients must have sufficiently recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, with the exception of alopecia
Participants may or may not be receiving hormonal therapy at the time of study entry
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (these patients are eligible if this therapy is discontinued prior to randomization)
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ? 36 months in duration and ? 9 months before randomization, or a single dose or a short course (? 6 months) of hormonal therapy given for rising PSA ? 9 months before randomization is allowed.;
Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure)
Any chemotherapy within 3 weeks of the first dose of AZD1775, except hormonal therapy in the refractory cohort.
Patients who have previously received hormonal therapy for endometrial cancer.
Patients may not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study other than hydroxyurea for control of counts
Subjects who have been on hormonal therapy up to 30 days prior to enrollment and receiving degarelix are allowed to be on the study
In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg.
No limit in number of prior hormonal agents in metastatic breast cancer; only one prior chemotherapy is allowed in metastatic setting; anti-HER2 targeting therapy, CDK4/6 inhibitor, other targeted therapy (e.g., mTOR or PI3K inhibitor) in combination with hormonal treatment will be counted as one hormonal agent; any anti-HER2 targeting therapy in combination with chemotherapy will not be counted as one additional treatment
Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment
History of hormonal therapy for endometrial carcinoma for more than 3 months;
Prior hormonal therapy:\r\n* Patients may have had prior hormonal therapy with any hormonal agent with the exception of fulvestrant or anastrozole in the neo-adjuvant, adjuvant, or metastatic setting and with subsequent documented progression, or while on treatment with fulvestrant or anastrozole hormonal therapy and as long as other study eligibility criteria are met\r\n* If the patient had adjuvant therapy with anastrozole and developed metastatic disease more than 6 months after completion of anastrozole in adjuvant setting, she is eligible to participate as long other eligibility criteria are met\r\n* If anastrozole or fulvestrant were used in the past but discontinued due to intolerance and not due to progression of disease the patient is eligible to participate in this study as long this felt clinically safe and acceptable by the principal investigator and discussed with the patient who is in agreement\r\n* All other active treatments for breast cancer such as radiation therapy, hormonal therapy or other investigational therapies will have to be discontinued >= 21days before the therapy T+P on this protocol is started
Patients treated with hormonal therapy are eligible for the study
Endocrine therapy\r\n* May have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer; patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks
Patients who have received prior hormonal therapy are excluded from the trial, except for: patients who have received up to 6 months of hormonal therapy as neoadjuvant therapy before radical prostatectomy or while on radiation therapy, as long as more than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy and initiation of hormonal treatment for relapsing disease
More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex)\r\n* Note: patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment; patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia
Treatment with another chemotherapy or hormonal therapy within the past 2 weeks
Subjects must have received prior hormonal therapy for the treatment of breast cancer as follows:\r\n* Progression must be documented while taking a nonsteroidal aromatase inhibitor including anastrozole or letrozole\r\n* If hormonal therapy was administered in the adjuvant setting, subjects must have received therapy for at least 6 months prior to developing metastatic disease\r\n* If hormonal therapy was administered in the metastatic setting, subjects must have received therapy for at least 3 months prior to progression
Prior non-hormonal therapy or radiation therapy for the current breast cancer; or hormonal therapy within 28 days prior to study entry; or refusal to discontinue hormonal therapy
Subject may have received prior hormonal therapy
Subjects may begin cediranib and olaparib at least 3 weeks after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible
Prior therapy for breast cancer, including irradiation, chemo-, immuno- and/or hormonal therapy
Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
If the subject has ER+ breast cancer, prior therapy must have included at least 1 hormonal therapy
Patients must have stable use of hormonal therapy for two weeks prior to cryoablation procedure)
Patients who have previously received enzalutamide; patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
Treatment with biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
Washout from prior hormonal therapy of at least 2 weeks prior to C1D1
Patients who are taking any form of other exogenous hormonal therapy within 21 days prior to first dose of orteronel; examples of exogenous hormonal therapy include: vaginal estrogens, transdermal testosterone, etc; the principal investigator (PI) will have the final say regarding what constitutes an exogenous hormonal therapy
Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed
Treatment with continuous or intermittent small molecular therapeutics, biologic therapy or hormonal therapy within 28 days prior to first dose of study treatment.
No prior hormonal therapy for treatment of cancer within the past 21 days
Patients may have a history of prior (non-colonic) malignancies, provided there is no current clinical evidence of persistent or recurrent disease and the patient is on no active therapy, including hormonal therapy
Has had prior hormonal therapy such as Lupron or oral anti-androgens
Hormonal therapy for prostate cancer within three months of procedure,
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and > 6 months before entry is acceptable)
Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy (Note: hormonal therapy is allowed)
In active cancer treatment or have completed active cancer treatment within 12 months of obtaining consent (with the exception of adjuvant hormonal therapy)
Prior therapy with hormonal progestin agents;
Hormonal therapy must have been discontinued =< 14 days prior to initiation of study therapy; however, continuation of ovarian suppression is allowed
Prior hormonal therapy is allowed (no washout period is required after hormonal therapy)
Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)
Patients who did not enroll during their chemotherapy are still eligible to enroll during subsequent hormonal therapy or radiation as long as it within 6 months of diagnosis
Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
Receiving hormonal treatment
Those prescribed a hormonal therapy for cancer
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Women over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms
Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date
Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention within the next year (Note: Individuals taking tamoxifen, Arimidex or other hormonal prevention strategies at time of consent will be eligible)
Concurrent use of hormonal contraception or hormone replacement therapy
Subjects who have received hormonal contraception and/or hormone therapy in the past 3 months are not eligible
Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
On adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
May or may not be on hormonal therapy, chemotherapy, or radium therapy; if on hormonal therapy or chemotherapy, must be on it for at least 3 months
Previous hormonal therapy is allowed
Are currently taking any hormonal therapy or have been on hormonal therapy in the past 4 weeks
Participants must have no immediate requirements for chemotherapy, radiotherapy or hormonal therapy
Completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)