Patients with hormone receptor positive breast cancer as defined above must plan to receive at least 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 % of cells, hormonal therapy for at least 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 regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit
Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within week prior to entering the study
hormonal therapy
Receipt of any other systemic anticancer therapy with the exception of hormonal therapy for a hormonally sensitive (e.g. breast or prostate) cancer (for treatment phase)
The most recent cytotoxic, biologic or non-hormonal targeted therapy received must have been completed at least days prior to study treatment
Cohort B Safety Run-In (Ribociclib + PDR + Fulvestrant): Prior hormonal therapy: \r\n* Participants may have received any number of previous endocrine / hormonal lines of therapy (including prior fulvestrant) in the metastatic setting, as long as the last dose is >= days prior to first dose of study treatment
Cohort A Dose Expansion (Ribociclib + PDR): Prior hormonal therapy: \r\n* Participants may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting, as long as the last dose is >= days prior to first dose of study treatment
one prior hormonal therapy and one prior chemotherapy regimen; or
Concomitant anticancer therapy, systemic immune therapy, or hormonal therapy as cancer therapy
Subject must not have had more than 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 months after stopping hormonal therapy; disease recurrence after hormonal therapy is defined as PSA > . ng/dl after prostatectomy + hormonal therapy or PSA that is . ng/dl more than the PSA nadir after radiotherapy + hormonal therapy; previous hormonal therapy to the prostate must have stopped at least months prior to enrollment
Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy)
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and greater than 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 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
Prior treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).
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 months by the time of screening and can start the study drug within 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
Concomitant treatment with other hormonal therapy or alpha-reductase inhibitors
Participant may have received prior hormonal therapy
Fewer than 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- and MVT-.
Patients who concurrently use hormonal therapy and/or concurrent radiation therapy
No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery other than the anthracycline and cyclophosphamide chemotherapy with or without -fluorouracil; treatment for ductal carcinoma in situ is allowed, such as surgery, hormonal therapy and radiotherapy
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 weeks prior to starting study treatment
For subjects enrolled in the Anastrozole Arm, prior hormonal therapy (including, but not limited to, tamoxifen, megestrol acetate, fulvestrant, and GnRH analogs) for the treatment of recurrent/advanced endometrial cancer are not allowed
Patients may have used prior hormonal therapy, but it should be limited to no more than months of therapy prior to enrollment
Chemotherapy (including hormonal therapy) within the past years from date of registration
Chemotherapy (including hormonal therapy) within the past years from date of registration
Hormonal therapy within weeks before the first dose of study treatment
Previous treatment with surgery, radiation or hormonal therapy is allowed
Hormonal therapy within week
Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the days before treatment; patients who have been on a hormonal agent for at least 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 may have received prior hormonal therapy; the hormonal treatment must have been discontinued for > months prior to study entry
Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
At least weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
Concurrent hormonal therapy, except for bisphosphonates,during or within days prior to start of study drug
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 weeks prior to registration
No hormonal therapy is allowed within week of initiating study treatment
Timing of prior therapy:\r\n* Prior hormonal therapy is allowed; hormonal therapy must be discontinued at least days before initiation of protocol therapy\r\n* Ovarian suppression which has been used for > 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 weeks prior to study entry\r\n* Patients must have completed radiation therapy at least 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)
Previous treatments with hormonal therapy (tamoxifen, aromatase inhibitors) and signal transduction agents (e.g., erlotinib, gefitinib, everolimus, bevacizumab) are allowed and are not counted towards the prior line of therapy.
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ? months in duration and ? months before randomization, or a single dose or a short course (? months) of hormonal therapy given for rising PSA ? 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
If taking hormonal therapy, use should be stable (no changes within weeks prior to the cryoablation procedure)
Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
Patients with metastatic sites that requires chemotherapy and/or non-hormonal targeted therapy
Any chemotherapy within weeks of the first dose of AZD, except hormonal therapy in the refractory cohort.
No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and hormonal therapy) is given
Patients who have previously received hormonal therapy for endometrial cancer.
During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
Participants must have stopped any hormonal therapy at least week prior to treatment with nivolumab and bevacizumab; participants may continue on hormone replacement therapy administered for post-menopausal symptoms
Subjects who have been on hormonal therapy up to 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 months prior to randomisation AND the total duration of hormonal treatment did not exceed 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. weeks after the last dose of depot goserelin .mg.
> weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this malignancy\r\n* NOTE: if the patient has received < weeks of such therapy but is still receiving it at the time of entry into the study, patient must temporarily stop the therapy; the therapy can re-start only after weeks of T-DM has been administered
Treatment with hormonal therapy (eg, androgen receptor inhibitors, -alpha reductase inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy) within weeks before enrollment;
No limit in number of prior hormonal agents in metastatic breast cancer; only one prior chemotherapy is allowed in metastatic setting; anti-HER targeting therapy, CDK/ inhibitor, other targeted therapy (e.g., mTOR or PIK inhibitor) in combination with hormonal treatment will be counted as one hormonal agent; any anti-HER 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 months of therapy prior to enrollment
At least weeks must have elapsed from the use of bicalutamide if used as part of an initial combined androgen blockage therapy for more than months or if used as second line hormonal therapy and associated with a PSA response of at least months duration
History of hormonal therapy for endometrial carcinoma for more than 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 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 >= days 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 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 weeks
Patients who have received prior hormonal therapy are excluded from the trial, except for: patients who have received up to months of hormonal therapy as neoadjuvant therapy before radical prostatectomy or while on radiation therapy, as long as more than year has elapsed between discontinuation of the neoadjuvant hormonal therapy and initiation of hormonal treatment for relapsing disease
More than 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 year after the drug is fully metabolized to start treatment on protocol
Treatment with another chemotherapy or hormonal therapy within the past 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 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 months prior to progression
Prior non-hormonal therapy or radiation therapy for the current breast cancer; or hormonal therapy within 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 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
If the subject has ER+ breast cancer, prior therapy must have included at least hormonal therapy
Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within weeks before study drug treatment
Patients who have received prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy
Patients must have stable use of hormonal therapy for two weeks prior to cryoablation procedure)
Is receiving any other concurrent systemic tumor therapy, including hormonal agents and HER- inhibitors
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 weeks prior to CD
Patients who are taking any form of other exogenous hormonal therapy within 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
Treatment with continuous or intermittent small molecular therapeutics, biologic therapy or hormonal therapy within days prior to first dose of study treatment.
No prior hormonal therapy for treatment of cancer within the past 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
Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy)
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and > months before entry is acceptable)
Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least months prior to study registration and plan to continue for the duration of the study ( months)
Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapy are allowed
Undergoing chemotherapy, hormonal therapy, or targeted therapy
Prior therapy with hormonal progestin agents;
Hormonal therapy must have been discontinued =< 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)
Participants must self-identify as being at least days post final chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery; current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
Treatment plan that includes any neoadjuvant or adjuvant therapy (either in the context of standard treatment or a clinical trial and including chemotherapy, treatments targeting the human epidermal growth factor receptor protein [HER]), hormonal therapy, or radiation; patients can receive any/all of these therapy components while on study in any combination
For those receiving chemotherapy/infusional therapy, patients have to enroll during the weeks prior to or on the day of treatment initiation; for those enrolling during hormonal therapy and/or radiation, patients must enroll within months of diagnosis of breast cancer, defined as the date of initial biopsy; patient may be receiving hormonal therapy, radiation therapy, or both at the time of enrollment
Receiving hormonal treatment
Those prescribed a hormonal therapy for cancer
Stable use of hormonal therapy (no changes within weeks prior to the cryoablation procedure)
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 months are not eligible
Anticipate needing secondary prostate cancer therapy within the next months (i.e. radiation, or hormonal therapy)
Hormonal therapy (tamoxifen, an aromatase inhibitor, or Lupron) is not permitted during radiation or during the subsequent weeks (the entire dose-limiting toxicity [DLT] window)
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 months
Patients must not have received hormonal therapy (i.e., tamoxifen, raloxifene, and/or aromatase inhibitors) for prevention of breast cancer within months of the biopsy documenting DCIS
Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within weeks prior to the first dose of study treatment
Previous hormonal therapy is allowed
Are currently taking any hormonal therapy or have been on hormonal therapy in the past weeks
Participants must have no immediate requirements for chemotherapy, radiotherapy or hormonal therapy
Completed acute treatment with intent to cure within the past months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)