- |||||||||| goserelin acetate / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg.
Trial completion, Surgery: RADICALS-HD: RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery (clinicaltrials.gov) - Nov 12, 2023 P3, N=4236, Completed, Three-month leuprorelin acetate is a safe and effective treatment for suppressing the pituitary-gonadal axis and restoring impaired adult height in Chinese girls. Unknown status --> Completed
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Concerning Discrepancies in Estradiol Levels in Premenopausal Women Receiving Abemaciclib and Ovarian Function Suppression (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_1694; As up to 91% of patients in our study may have had a false positive estradiol level erroneously suggesting inadequate OFS, monitoring of estradiol levels using the CMIA assay in patients receiving adjuvant abemaciclib in addition to OFS could lead to changes in therapy that may be unnecessary. It is recommended that the LC-MS/MS assay be used when monitoring of estradiol levels is indicated in patients receiving abemaciclib concurrently with OFS.
- |||||||||| Ibrance (palbociclib) / Pfizer, Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Hiding in plain sight: A heterogeneous response in a patient with metastatic HR+/HER2- breast cancer (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_967; It is recommended that the LC-MS/MS assay be used when monitoring of estradiol levels is indicated in patients receiving abemaciclib concurrently with OFS. She tolerated one week of tamoxifen which was discontinued due to adverse effects...Patient was started on letrozole with lupron and palbociclib with disease control for two years until progression in the bone, prompting a switch of letrozole to fulvestrant with continued palbociclib...She was then started on single-agent paclitaxel...She opted to enroll into a Phase 1b/2 trial with sacituzumab govitecan-hziy in combination with a PARPi...A history of mixed response in the liver was concluded to be two coexisting neoplasms
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas
Trial completion, Trial completion date, Trial primary completion date, HEOR, Real-world evidence: Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov) - Nov 3, 2023 P=N/A, N=1, Completed, She tolerated one week of tamoxifen which was discontinued due to adverse effects...Patient was started on letrozole with lupron and palbociclib with disease control for two years until progression in the bone, prompting a switch of letrozole to fulvestrant with continued palbociclib...She was then started on single-agent paclitaxel...She opted to enroll into a Phase 1b/2 trial with sacituzumab govitecan-hziy in combination with a PARPi...A history of mixed response in the liver was concluded to be two coexisting neoplasms Recruiting --> Completed | Trial completion date: Nov 2023 --> Jun 2023 | Trial primary completion date: Nov 2023 --> Jun 2023
- |||||||||| enzalutamide capsule / Generic mfg.
Journal: Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. (Pubmed Central) - Oct 22, 2023 P3 The safety profile of enzalutamide was consistent with that shown in previous clinical studies, with no apparent detrimental effect on quality of life. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.).
- |||||||||| Kisqali (ribociclib) / Novartis
Trial initiation date, Trial primary completion date, Real-world evidence: ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov) - Oct 16, 2023 P3, N=2500, Not yet recruiting, (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.). Initiation date: Sep 2023 --> Jan 2024 | Trial primary completion date: Jun 2030 --> Jul 2028
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
P3 data, Journal, HEOR, Metastases: Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (Pubmed Central) - Oct 14, 2023 Relugolix had similar efficacy for men with/without CRFS progression events. Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.
- |||||||||| sunitinib / Generic mfg.
Trial completion date, Trial primary completion date: Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov) - Oct 13, 2023 P2, N=64, Active, not recruiting, Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., zoledronic acid / Generic mfg., fulvestrant / Generic mfg.
End-of-life chemotherapy and palliative care utilization among patients with breast cancer treated at a safety-net system. (3rd Floor, Back Bay Hall; Poster Bd #: H4) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_502; In addition, less than half of the patients in our study completed a palliative care visit before death. Late palliative care referral, timely access, understanding the benefit of the service, low health literacy, language barrier, cultural considerations, and physicians
- |||||||||| docetaxel / Generic mfg.
Trial completion date, Metastases: Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer (clinicaltrials.gov) - Oct 12, 2023 P1, N=20, Active, not recruiting, Late palliative care referral, timely access, understanding the benefit of the service, low health literacy, language barrier, cultural considerations, and physicians Trial completion date: Sep 2023 --> Dec 2023
- |||||||||| Trial completion, Enrollment change, Trial completion date, Trial primary completion date: STAMP: Strength, Aging, and Memory in Prostate Cancer (clinicaltrials.gov) - Oct 12, 2023
P=N/A, N=20, Completed, Trial completion date: Sep 2023 --> Dec 2023 Active, not recruiting --> Completed | N=60 --> 20 | Trial completion date: Jul 2024 --> Apr 2023 | Trial primary completion date: Jul 2024 --> Apr 2023
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Preclinical, Journal: Puberty suppression followed by testosterone therapy does not impair reproductive potential in female mice. (Pubmed Central) - Sep 28, 2023 This study used a translational murine IVF model to examine the effects of female puberty suppression with depot leuprolide acetate (LA), followed by virilizing therapy with testosterone cypionate (T), on embryologic and pregnancy outcomes...Eggs from mice treated with LA and T were fertilizable and produced developmentally competent embryos that led to births of fertile pups. These results suggest that fertility may not be impaired after puberty suppression and cross-hormone therapy for transgender males.
- |||||||||| Kisqali (ribociclib) / Novartis
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (clinicaltrials.gov) - Sep 22, 2023 P2, N=116, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Apr 2028 | Trial primary completion date: Dec 2022 --> Mar 2024 Recruiting --> Active, not recruiting | N=194 --> 116 | Trial primary completion date: Dec 2022 --> Dec 2024
- |||||||||| Yselty (linzagolix) / Kissei, Theramex, Syneos Health
Enrollment closed: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (clinicaltrials.gov) - Sep 21, 2023 P3, N=264, Active, not recruiting, Recruiting --> Active, not recruiting | N=194 --> 116 | Trial primary completion date: Dec 2022 --> Dec 2024 Recruiting --> Active, not recruiting
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), nelitolimod (SD-101) / TriSalus Life Sci, UT MD Anderson Cancer Center
Trial completion date, Trial primary completion date: Pembrolizumab +/- SD-101 in Hormone-Na (clinicaltrials.gov) - Sep 14, 2023 P2, N=23, Active, not recruiting, Relugolix suppressed testosterone and was generally well tolerated when given with concomitant CV agents. Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas
Trial initiation date: ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov) - Aug 18, 2023 P4, N=228, Not yet recruiting, While efficacy data are needed to evaluate the oncologic benefit, these data suggest a short course of AAT is considerably better tolerated than longer courses of AAT, with grade 3 toxicity rates similar to long courses of single-agent androgen deprivation therapy alone. Initiation date: Jul 2023 --> Oct 2023
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Suprefact (buserelin acetate) / Sanofi
Review, Journal: Hormonal Treatments in Hidradenitis Suppurativa: A Systematic Review. (Pubmed Central) - Aug 13, 2023 Anti-androgen treatments discussed include finasteride (n=8), spironolactone (n=7), cyproterone acetate (CPA) (n=5), flutamide (n=1), leuprolide (n=1), and buserelin acetate (n=1)...Improvement in HS was also noted in case reports of patients treated with buserelin acetate, leuprolide, flutamide, and liraglutide. Hormonal treatments for HS, especially finasteride, spironolactone, and metformin, are efficacious and safe; but large-scale randomized controlled trials are needed to determine the patient populations which would benefit from these therapies...2023;22(8):785-794. doi:10.36849/JDD.7325.
- |||||||||| trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open, Trial completion date, Trial primary completion date, Metastases: A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - Aug 2, 2023 P2, N=66, Recruiting, The first rank of dienogest pregnancy was the highest. Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025
- |||||||||| Welireg (belzutifan) / Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date: A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer (clinicaltrials.gov) - Aug 1, 2023 P2, N=30, Not yet recruiting, Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025 Trial completion date: Jul 2025 --> Jul 2026 | Initiation date: Jul 2023 --> Jan 2024 | Trial primary completion date: Jan 2024 --> Jan 2025
- |||||||||| Ibrance (palbociclib) / Pfizer, Avastin (bevacizumab) / Roche, Halaven (eribulin mesylate) / Eisai
Journal, BRCA Biomarker, PD(L)-1 Biomarker, IO biomarker: A Case of Breast Carcinoma That Changed Subtype to Squamous Cell Carcinoma after Chemotherapy (Pubmed Central) - Jul 31, 2023 left breast cancer T2N2bM1(HEP)(ER 90%, PR 70%, HER2 2+, FISH-)at another hospital and participated in the PATHWAY study(tamoxifen plus goserelin plus palbociclib/placebo)...She was treated at our hospital thereafter, with capecitabine plus cyclophosphamide, palbociclib plus fulvestrant plus leuprorelin, paclitaxel plus bevacizumab, eribulin, EC therapy, and docetaxel...Therefore, left mastectomy plus pectoralis major muscle resection was performed. The patient died one month after the operation.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Recurrent Hemorrhagic Abdominal Ascites Secondary to Poorly-Controlled Endometriosis (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4458; Her outpatient therapy with Leuprolide was inconsistent due to financial difficulty...Surgical intervention is the more definitive treatment but most females affected are nulliparous and typically do not opt for radical surgery. Due to the debilitating nature of this disease, clinical suspicion should be high, and patients should be made aware of all treatment options including hormonal and surgical.
- |||||||||| Development of Celiac Disease After Immunotherapy for Psoriasis, Breast Cancer, and Renal Cell Carcinoma: A Case Series (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_1756;
Case Description/ A 21 year old female with psoriasis on ixekizumab (IL-17A antagonist) and recent dose of risankizumab (IL-23A antibody) presented with abdominal pain, diarrhea, and bloating...Colonoscopy showed lymphocytic colitis, and she started budesonide and gluten free diet with some improvement...A 49 year old female with invasive ductal carcinoma was treated with leuprolide, exemestane, trastuzumab and pertuzumab (anti-HER2 antibodies) and developed severe watery diarrhea requiring hospitalization for electrolyte abnormalities and total parenteral nutrition...An 82 year old male with metastatic renal cell carcinoma was treated with axitinib, complicated by diarrhea requiring dose reduction, and pembrolizumab, discontinued due to colitis requiring prednisone, then cabozantinib, complicated by diarrhea which persisted after dose reduction...Figure: Figure: Duodenal Biopsy of Case 3, Celiac Disease in an 82 year old male with metastatic renal cell carcinoma treated with axitinib, pembrolizumab, and cabozantinib. (A) Routine H&E staining of a duodenal biopsy showed subtotal to total villous atrophy, (B) Duodenal biopsy with thickened sub-epithelial collagen layer highlighted on trichrome stain, (C) Duodenal biopsy with intraepithelial lymphocytosis confirmed by CD3 immunohistochemistry Table: Immunotherapies and Presentations of Celiac Disease
- |||||||||| Opdivo (nivolumab) / BMS
Trial primary completion date: Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - Jul 28, 2023 P2, N=60, Recruiting, (A) Routine H&E staining of a duodenal biopsy showed subtotal to total villous atrophy, (B) Duodenal biopsy with thickened sub-epithelial collagen layer highlighted on trichrome stain, (C) Duodenal biopsy with intraepithelial lymphocytosis confirmed by CD3 immunohistochemistry Table: Immunotherapies and Presentations of Celiac Disease Trial primary completion date: Jun 2023 --> Jun 2024
- |||||||||| Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: SOLAR: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer (clinicaltrials.gov) - Jul 28, 2023 P2, N=28, Active, not recruiting, Trial primary completion date: Jun 2023 --> Jun 2024 Trial completion date: Jun 2023 --> Mar 2024 | Trial primary completion date: Sep 2022 --> Mar 2024
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