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- leuprorelin depot / Generic mfg.
[VIRTUAL] Effects of GnRHa on ovarian function against chemotherapy-induced gonadotoxicity in premenopausal women with breast cancer in China: A prospective randomized controlled trial (EGOFACT) () - Jul 22, 2021 - Abstract #ESMO2021ESMO_1519;
P3
We randomly assigned 345 premenopausal women with operable breast cancer to receive standard cyclophosphamide-containing chemotherapy with the GnRHa (goserelin or leuprorelin) or standard chemotherapy without GnRHa (control group) from Sept 1st, 2015 to Aug 31st, 2017. Administration of GnRHa with chemotherapy in premenopausal patients with breast cancer reduces the risk of POI and improves the tumor-free survival in patients under 35 years old.
- leuprorelin depot / Generic mfg.
[VIRTUAL] Puberty () - Jul 19, 2021 - Abstract #ESPE2021ESPE_221;
Large cohort studies bring more information regarding secular trends in central precocious puberty, premature thelarche or adrenarche but also gynecomastia. This presentation will also addresse new discoveries regarding the effect of prenatal stress on pubertal timing and the results of the first phase 3 study of a subcutaneous 6-month leuprolide acetate.
- | Enrollment open: VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov) - Jul 12, 2021
P2/3, N=464, Recruiting, Sponsor: VA Office of Research and Development
This presentation will also addresse new discoveries regarding the effect of prenatal stress on pubertal timing and the results of the first phase 3 study of a subcutaneous 6-month leuprolide acetate. Not yet recruiting --> Recruiting
- || Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Agree all stars indeed! Is there a lupron abi xrt trial for very high risk locally advanced ? Must be no? (Twitter) - Jul 9, 2021
- | Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Please ensure that the makers and distributors of Lupron are also held to account, or I won't believe you mean it. (Twitter) - Jul 8, 2021
- |||| Piqray (alpelisib) / Novartis
Enrollment open, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Jul 7, 2021
P2, N=390, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting
- | Journal: From micro to nano: evolution and impact of drug delivery in treating disease. (Pubmed Central) - Jul 4, 2021
Very recently, the first siRNA lipid nanoparticle medicine, Patisiran (Onpattro®), was approved for treating hereditary transthyretin-mediated amyloidosis. In this inspirational note, we will highlight the technological evolution of drug delivery from micro- to nano-, citing some of the approved medicines demonstrating the significant impact of the drug delivery field in treating many diseases.
- ||| Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
P3 data, Journal: Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. (Pubmed Central) - Jul 3, 2021
P3
In this inspirational note, we will highlight the technological evolution of drug delivery from micro- to nano-, citing some of the approved medicines demonstrating the significant impact of the drug delivery field in treating many diseases. Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
- |||| leuprolide acetate for depot suspension / Generic mfg.
Enrollment open, Metastases: BSV_LEUPR_18_05: Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer (clinicaltrials.gov) - Jul 1, 2021
P3, N=168, Recruiting, Sponsor: Bharat Serums and Vaccines Limited
Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer. Not yet recruiting --> Recruiting
- | Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Subgenual cingulate resting regional cerebral blood flow in premenstrual dysphoric disorder: differential regulation by ovarian steroids and preliminary evidence for an association with expression of ESC/E(Z) complex genes. (Pubmed Central) - Jun 30, 2021
In addition, in PMDD, ESC/E(Z) gene expression correlated with the change in resting rCBF between Lupron-alone and progesterone conditions (Pearson r = -0.807, P = 0.016). This work offers a formulation of PMDD that integrates behavioral, neural circuit, and cellular mechanisms, and may provide new targets for future therapeutic interventions.
- | Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Effect of Manufacturing Variables and Raw Materials on the Composition-Equivalent PLGA Microspheres for 1-Month Controlled Release of Leuprolide. (Pubmed Central) - Jun 8, 2021
The 1-month Lupron Depot (LD) is a 75/25 acid-capped poly(lactic-co-glycolic acid) (PLGA) microsphere product encapsulating water-soluble leuprolide acetate with no generic products available in the U.S. Composition-equivalent PLGA microsphere formulations to the LD as a function of raw material and manufacturing variables were developed by using the solvent evaporation encapsulation method...The in vitro release kinetics of the formulations were highly similar to the LD in a zero-order manner after ~20% initial burst release, indicating a critical role of the composition on peptide release in this formulation. The characterization of composition-equivalent formulations described here could be useful for further development of generic leuprolide PLGA microspheres, and for guiding decisions on the influence of process variables on product physicochemical attributes and release performance.
- |||||||| leuprolide acetate for depot suspension / Generic mfg.
New P3 trial, Metastases: BSV_LEUPR_18_05: Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer (clinicaltrials.gov) - Jun 3, 2021
P3, N=168, Not yet recruiting, Sponsor: Bharat Serums and Vaccines Limited
- ||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Good, Comment Piet oligo applies to more than SBRT though few slow will do well makes you wonder if we could avoid primary treatment of prostate cancer in older men wait for Mets treat with abi:/ Lupron SBRT ! (Twitter) - Jun 2, 2021
- | Firmagon (degarelix) / Astellas, Ferring
New trial: Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data (clinicaltrials.gov) - May 24, 2021
P, N=14417, Active, not recruiting, Sponsor: Brigham and Women's Hospital
- | leuprolide acetate for depot suspension / Generic mfg., tamoxifen / Generic mfg.
New trial: Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer (clinicaltrials.gov) - May 17, 2021
P, N=120, Not yet recruiting, Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- | Trial completion date, Trial primary completion date: STAMP: Strength, Aging, and Memory in Prostate Cancer (clinicaltrials.gov) - May 15, 2021
P=N/A, N=60, Not yet recruiting, Sponsor: University of Nebraska
The characterization of composition-equivalent formulations described here could be useful for further development of generic leuprolide PLGA microspheres, and for guiding decisions on the influence of process variables on product physicochemical attributes and release performance. Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
- ||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
we need the reunion basketball game, "Lupron" cup with @USC_Urology and Kaiser Urology (Twitter) - May 11, 2021
- || Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Including financial toxicity - my Lupron is $400/mo with my platinum PPO (Twitter) - May 8, 2021
- | Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: PEER: Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - May 7, 2021
P1/2, N=25, Recruiting, Sponsor: National Taiwan University Hospital
Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- ||||||| Firmagon (degarelix) / Astellas, Ferring
Trial completion, Adverse events, Metastases: PRONOUNCE: A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease (clinicaltrials.gov) - Apr 29, 2021
P3, N=545, Completed, Sponsor: Ferring Pharmaceuticals
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021 Active, not recruiting --> Completed
- ||| Piqray (alpelisib) / Novartis
Enrollment closed, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Apr 28, 2021
P2, N=382, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: The use of GnRH-agonist trigger for the final maturation of oocytes in normal and low responders undergoing planned oocyte cryopreservation. (Pubmed Central) - Apr 28, 2021
C.S., M.G., L.R. and J.K. have nothing to disclose. N/A.
- ||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Reimbursement: My last point on relugolix—if your insurance company gave you $20k and told you to pay OOP for your own testosterone supp for 6 mo but you get to keep the rest, would you choose lupron ($3k) or relugolix ($18k)? I know that’s not how it works, but it does focus the mind on value. (Twitter) - Apr 25, 2021
- || Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Where’s the proof that compliance is higher with relugolix than Lupron? Might be worse, no? Also, what’s the theory for fewer cardiac effects? Seems more likely it is statistical noise in the study the company is capitalizing on. (Twitter) - Apr 25, 2021
- |||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Firmagon (degarelix) / Astellas, Ferring
Clinical: True, I give lupron as default. In patients with a history of major cardiovascular events the Hero data showed 4% vs 18% CV events. That may be worth it and I (try) tend to give it or firmagon in those patients. Firmagon is a bit unwieldy though. (Twitter) - Apr 24, 2021
- | Trial completion date: A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy (clinicaltrials.gov) - Apr 22, 2021
P2, N=26, Active, not recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
N/A. Trial completion date: Feb 2022 --> Feb 2024
- ||| Kisqali (ribociclib) / Novartis
Trial completion date, Combination therapy, Metastases: CompLEEment-1: Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC (clinicaltrials.gov) - Apr 22, 2021
P3, N=3255, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2022 --> Feb 2024 Trial completion date: May 2021 --> May 2022
- | leuprolide acetate for depot suspension / Generic mfg., docetaxel / Generic mfg.
Trial completion date, Trial primary completion date: A Registry for Patients Treated on the Clinical Trial TAX 3503 (clinicaltrials.gov) - Apr 22, 2021
P3, N=52, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: May 2021 --> May 2022 Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
- || letrozole / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., everolimus / Generic mfg.
Trial completion date, Trial primary completion date: Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC) (clinicaltrials.gov) - Apr 22, 2021
P2, N=84, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022 Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- | New trial: STAMP: Strength, Aging, and Memory in Prostate Cancer (clinicaltrials.gov) - Apr 20, 2021
P, N=60, Not yet recruiting, Sponsor: University of Nebraska
- | cabazitaxel / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: ACDC-RP: Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial) (clinicaltrials.gov) - Apr 19, 2021
P2, N=76, Active, not recruiting, Sponsor: University Health Network, Toronto
Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022 Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2022 | Trial primary completion date: Aug 2020 --> Dec 2021
- || Kepivance (palifermin) / SOBI, Amgen, Firmagon (degarelix) / Astellas, Ferring
Enrollment closed: Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Apr 15, 2021
P2, N=82, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2022 | Trial primary completion date: Aug 2020 --> Dec 2021 Recruiting --> Active, not recruiting
- ||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Enrollment closed, Metastases: HERO: A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (clinicaltrials.gov) - Mar 25, 2021
P3, N=1134, Active, not recruiting, Sponsor: Myovant Sciences GmbH
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
I was taking Lupron injections, but decided to have a preventive hysterectomy. I don't regret that decision for a second! Freedom 😄😊 (Twitter) - Mar 22, 2021
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, Rubraca (rucaparib) / Pharma& Schweiz
Trial suspension, Metastases: CASPAR: A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy (clinicaltrials.gov) - Mar 21, 2021
P3, N=1002, Suspended, Sponsor: Alliance for Clinical Trials in Oncology
Recruiting --> Active, not recruiting Not yet recruiting --> Suspended
- Lupron Depot (leuprorelin depot) / AbbVie, Takeda
[VIRTUAL] The Silent Killer: An Asymptomatic Catamenial Pneumothorax in a Patient with a Previous Partial Hysterectomy () - Mar 14, 2021 - Abstract #ATS2021ATS_1;
Patient refused Lupron therapy and she was advised to consider right unilateral oophorectomy once she recovered...Secondary prevention usually involves a surgical thoracoscopy procedure and should ideally be performed during menstruation for optimal visualization of pleurodiaphragmatic implants. Additionally, patients may require blebectomy and pleurodesis and post-op recommendations indicate hormonal suppression for six to twelve months.
- | goserelin acetate / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., flutamide / Generic mfg.
Trial completion date: Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer (clinicaltrials.gov) - Mar 9, 2021
P3, N=226, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
Additionally, patients may require blebectomy and pleurodesis and post-op recommendations indicate hormonal suppression for six to twelve months. Trial completion date: Dec 2020 --> Dec 2021
- | emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Enrollment open: Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW (clinicaltrials.gov) - Mar 9, 2021
P1, N=20, Recruiting, Sponsor: Johns Hopkins University
Trial completion date: Dec 2020 --> Dec 2021 Not yet recruiting --> Recruiting
- | New P2/3 trial: VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov) - Mar 9, 2021
P2/3, N=464, Not yet recruiting, Sponsor: VA Office of Research and Development
- || New P1 trial: To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers (clinicaltrials.gov) - Mar 4, 2021
P1, N=40, Not yet recruiting, Sponsor: Peptron, Inc.
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas
Trial completion date, Trial primary completion date, Metastases: LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - Mar 3, 2021
P2, N=92, Active, not recruiting, Sponsor: Barbara Ann Karmanos Cancer Institute
Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- | Suprefact (buserelin acetate) / Sanofi, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Enrollment open: Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial (clinicaltrials.gov) - Feb 25, 2021
P3, N=2478, Recruiting, Sponsor: NRG Oncology
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Not yet recruiting --> Recruiting
- | leuprolide acetate for depot suspension / Generic mfg.
Trial completion: Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation (clinicaltrials.gov) - Feb 23, 2021
P2, N=76, Completed, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Vesanoid (tretinoin) / Roche
Trial completion date, Trial primary completion date: A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment (clinicaltrials.gov) - Feb 23, 2021
P2, N=20, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Active, not recruiting --> Completed Trial completion date: Sep 2021 --> Aug 2022 | Trial primary completion date: Jun 2021 --> Feb 2022
- | Xtandi (enzalutamide) / Pfizer, Astellas, Erleada (apalutamide) / J&J
Enrollment closed, Trial completion date, Trial primary completion date: Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov) - Feb 21, 2021
P=N/A, N=60, Active, not recruiting, Sponsor: Medical College of Wisconsin
Trial completion date: Sep 2021 --> Aug 2022 | Trial primary completion date: Jun 2021 --> Feb 2022 Recruiting --> Active, not recruiting | Trial completion date: Feb 2022 --> Jun 2023 | Trial primary completion date: Feb 2021 --> Jun 2022
- | Estrace (estradiol) / AbbVie
Trial completion date, Trial primary completion date: Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model (clinicaltrials.gov) - Feb 21, 2021
P2, N=30, Recruiting, Sponsor: University of North Carolina, Chapel Hill
Recruiting --> Active, not recruiting | Trial completion date: Feb 2022 --> Jun 2023 | Trial primary completion date: Feb 2021 --> Jun 2022 Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- | emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
New P1 trial: Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW (clinicaltrials.gov) - Feb 18, 2021
P1, N=20, Not yet recruiting, Sponsor: Johns Hopkins University
- Herceptin (trastuzumab) / Roche
[VIRTUAL] Cutaneous Apocrine Carcinoma of the Scrotum: A Multi-institutional Clinicopathologic Analysis of 6 Cases and Comparison with Extramammary Paget Disease () - Feb 15, 2021 - Abstract #USCAP2021USCAP_504;
Distinction of AC from EMPD is important for prognostication and management. Similarities with mammary carcinoma raises consideration for breast cancer specific therapy.
- ||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Clinical: @RealProstateDoc what's the deal with orgovyx? Saw my first patient on it. Is it a Lupron killer? Stock to buy maybe? (Twitter) - Feb 9, 2021
- || Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov) - Feb 9, 2021
P2, N=64, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Similarities with mammary carcinoma raises consideration for breast cancer specific therapy. Trial completion date: May 2021 --> May 2022 | Trial primary completion date: May 2021 --> May 2022