 |
114 Diseases |  |
361 Trials |
|
361 Trials |  |
7200 News |  |
| «12...4849505152535455565758...100101» |
- | Verzenio (abemaciclib) / Eli Lilly
Trial primary completion date: Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer (clinicaltrials.gov) - May 3, 2021
P1, N=27, Recruiting, Sponsor: Northwestern University
Trial primary completion date: Jul 2021 --> Jul 2022
- | letrozole / Generic mfg.
Trial completion date, Trial initiation date, Trial primary completion date: Phase II Study of Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI) (clinicaltrials.gov) - May 2, 2021
P2, N=28, Not yet recruiting, Sponsor: Dartmouth-Hitchcock Medical Center
Trial primary completion date: Jul 2021 --> Jul 2022 Trial completion date: Mar 2024 --> Jun 2024 | Initiation date: Mar 2021 --> Jun 2021 | Trial primary completion date: Mar 2023 --> Jun 2023
- | letrozole / Generic mfg.
Preclinical, Journal: Letrozole Rat Model Mimics Human Polycystic Ovarian Syndrome and Changes in Insulin Signal Pathways. (Pubmed Central) - May 1, 2021
Disrupted insulin signaling contributes to the decrease in insulin sensitivity and compensatory hyperinsulinemia in PCOS rats. CONCLUSIONS Continuous administration of letrozole and high-fat diets can induce PCOS, metabolic phenotypes, and disrupted activation of the insulin signaling pathway.
- | letrozole / Generic mfg.
Preclinical, Journal: Sex-dimorphic aromatase regulation of ventromedial hypothalamic nucleus glycogen content in euglycemic and insulin-induced hypoglycemic rats. (Pubmed Central) - May 1, 2021
Here, the aromatase inhibitor letrozole (Lz) was used alongside high-resolution microdissection/UPHLC-electrospray ionization-mass spectrometric methods to determine if neuroestradiol imposes sex-specific control of VMN glycogen content during glucostasis and/or glucoprivation...Locally-generated estradiol is evidently involved in hypoglycemic enhancement of male VMN glycogen, but conversely limits glycogen content in hypoglycemic females. Further research is needed to characterize mechanisms that underlie the directional shift in aromatase regulation of VMN glycogen in eu- versus hypoglycemic male rats and gain in negative impact in hypoglycemic females.
- | letrozole / Generic mfg.
Journal: Design, synthesis and biological evaluation of imidazole and triazole-based carbamates as novel aromatase inhibitors. (Pubmed Central) - May 1, 2021
The effect of most active derivatives 13a and 15c was then evaluated in vitro on the human breast cancer cell line MCF7 by MTT assay, cytotoxicity assay (LDH release) and cell cycle analysis, revealing a dose-dependent inhibition profile of cell viability and low micromolar IC values. In addition, docking simulations were also carried out to elucidate at a molecular level of detail the binding modes adopted to target human aromatase.
- | letrozole / Generic mfg.
Journal: Highly Functionalized Modified Metal Oxides Polymeric Sensors for Potentiometric Determination of Letrozole in Commercial Oral Tablets and Biosamples. (Pubmed Central) - May 1, 2021
The conventional type LTZ-PM showed a potential response E = (53.3 ± 0.5) log [LTZ] + 451.4 over concentration range of 1.0 × 10-1.0 × 10 mol L. The suggested sensors were successfully used to determine LTZ in pharmaceutical formulations and biosamples. Method validation ensured the suitability of the suggested potentiometric sensors.
- ||| letrozole / Generic mfg.
Preclinical, Journal, Adverse events: Modulation of steroidogenesis by Actaea racemosa and vitamin C combination, in letrozole induced polycystic ovarian syndrome rat model: promising activity without the risk of hepatic adverse effect. (Pubmed Central) - May 1, 2021
Method validation ensured the suitability of the suggested potentiometric sensors. This study demonstrated the benefit of the combinatorial effects of AR and vitamin C in mitigating the reproductive and metabolic disorders associated with PCOS with the elimination of AR hepatotoxic risk.
- Herceptin (trastuzumab) / Roche
[VIRTUAL] FDA Authorized Treatment Protocol Using DeltaRex-G with Trastuzumab and Letrozole as First Line Therapy for Early Stage Triple Receptor Positive Breast Carcinoma () - Apr 30, 2021 - Abstract #ASGCT2021ASGCT_678;
A clinical progress update will be presented. A Phase 2/3 clinical trial is planned to evaluate if DeltaRex-G is equally effective (not-inferior-to) than standard chemotherapy/radiation therapy as first-line therapy for early-stage hormone receptor positive and HER2/neu amplified breast cancer.
- | letrozole / Generic mfg.
Journal: Suppressed estrogen supply via extra-ovarian progesterone receptor membrane component 1 in menopause. (Pubmed Central) - Apr 30, 2021
In MCF-7 cell, letrozole suppressed PR expression, but PGRMC1 knockdown increased PR and STS expression. Our presented results highlight the important role of Pgrmc1 in modulating estrogen production when ovary-derived estrogen is limited, thereby suggesting a potential therapeutic approach for letrozole resistance.
- Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4918;
It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert . Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise.
- ENMD-2076 / CASI, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
[VIRTUAL] Computational extraction and analysis of de-identified medical records to characterize hyperammonemia in patients with fibrolamellar carcinoma (FLC). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4326;
Herein, we have defined hyperammonemia as a frequent event in FLC, not directly linked to hepatic dysfunction or individual therapies . Further investigation may determine whether hyperammonemia is related to FLC tumor biology.
- Xalkori (crizotinib) / Pfizer, Ibrance (palbociclib) / Pfizer
[VIRTUAL] Experience on the diagnosis and treatment of multiple active primary cancers in our Institution. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4060;
Unexpectedly, use of palbociclib in a patient with breast cancer and chronic lymphoblastic leukemia might aggravate the leukemia, because one week of palbociclib plus letrozole led to a sharp WBC increase with a lymphocyte predominance and quickly reduced to the baseline after drug discontinuation...Six MAPC patients including 1 ROS-1 rearranged lung cancer, 4 EGFR mutant lung cancer, and 2 HER2 positive breast cancer were treated with corresponding targeted agents (crizotinib, gefitinib and lapatinib)... The diagnosis and treatment of MAPC has no standards and should integrate all available resources by a specific multidisciplinary team.
- tamoxifen / Generic mfg., fulvestrant / Generic mfg.
[VIRTUAL] Relative risk of hepatotoxicity associated with cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3729;
Cyclin-dependent kinase 4/6 inhibitors are associated with significant risk of any grade and grade 3/4 hepatic enzymes elevation . Regular monitoring of liver function is a key to early detection and initiation of appropriate management.
- fulvestrant / Generic mfg.
[VIRTUAL] Effect of cyclin-dependent kinase 4 and 6 inhibitors (CDKIs) on body composition (BC) in patients (pts) with hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer (MBC). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3725;
Given the known effect of obesity on breast cancer prognosis, CDKIs may have an additional effect on breast cancer prognosis by modulating body fat . Further studies are required to determine if decrease in SAT is associated with breast cancer outcomes or toxicities in pts on CDKIs.
- fulvestrant / Generic mfg.
[VIRTUAL] Real-world outcomes from the systemic use of CDK 4/6 inhibitors (CDKIs) in the management of ER positive (+) HER2 negative (-) metastatic breast cancer (mBC). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3723;
The analysis was not powered to delineate survival benefit between the individual CDKIs . Presentations with mBC following a prior history of EBC, within ≤12 months of completion of adjuvant endocrine therapy, and with visceral metastases may help predict poorer clinical outcomes and may need to be considered when prognosticating and in treatment planning .
- fulvestrant / Generic mfg.
[VIRTUAL] Real-world analysis of disease progression after CDK 4/6 inhibitor (CDKi) therapy in patients with hormone receptor positive (HR+)/HER2- metastatic breast cancer (MBC). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3722;
Rapid progression or death at 4 months occurred in 31% of MBCs following CDKi dc due to progression . Ongoing studies to define clinical and molecular characteristics of rapidly progressing tumors are underway to develop targeted tx approaches and improve outcomes.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Initial real life experience with ribociclib in breast cancer: Outcome with focus on tolerance and cardiac toxicity. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3716;
Treatment discontinuation rate is higher than that reported in clinical trials with stringent inclusion criteria . Ribociclib associated cardiac toxicity can be appropriately managed with careful monitoring.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Australian real-world outcomes of ribociclib and aromatase inhibitor in hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): Results from Kisqali Access Registry for Metastatic breast cancer in Australia (KARMA) collected alongside a medicine access program. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3710;
The combination treatment was well tolerated with similar rates of dose reductions (58% in both) and treatment discontinuation due to toxicity (10% vs 8%) when compared to MONALEESA-2 . This real-world cohort achieved a superior PFS, potentially explained in part by a younger population with more favourable baseline disease characteristics, including fewer disease sites and higher rates of bone only metastases .
- tamoxifen / Generic mfg.
[VIRTUAL] Determination of endocrine sensitivity by response of the proliferative marker KI67 after short-term preoperative endocrine therapy and their correlation to oncotype score platform. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3676;
Of note, in premenopausal patients, ES rate in RS > 26 is only of 33% . Determination of ES by response of ki67 is feasible and correlates with data of genomic platforms .
- | letrozole / Generic mfg.
Journal: Circulating miR-30b levels increase during male puberty. (Pubmed Central) - Apr 29, 2021
P2/3
Determination of ES by response of ki67 is feasible and correlates with data of genomic platforms . Circulating miR-30b expression in boys with CDGP increases in the course of puberty, and appears to be related to the activity of the HPG axis.
- | letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole in Stimulated IVF Cycles (clinicaltrials.gov) - Apr 29, 2021
P3, N=900, Recruiting, Sponsor: The University of Hong Kong
Circulating miR-30b expression in boys with CDGP increases in the course of puberty, and appears to be related to the activity of the HPG axis. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- tamoxifen / Generic mfg.
[VIRTUAL] Associations between preexisting nociplastic pain and early discontinuation of aromatase inhibitor therapy in breast cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_3407;
Greater pre-existing nociplastic pain was associated with early discontinuation of AI therapy . For these patients, early interventions that target centralized pain, or treatment with tamoxifen instead of AI therapy, may be appropriate in order to reduce risk of nonpersistence with AI therapy.
- letrozole / Generic mfg., carboplatin / Generic mfg., paclitaxel / Generic mfg.
[VIRTUAL] A randomized phase III, two-arm trial of paclitaxel, carboplatin, and maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2215;
P3
The study includes two interim analyses; at 20% information time, a futility analysis will be conducted, and at 40% information time, both efficacy and futility will be assessed . This is one of the first randomized trials performed in women with primary, advanced LGSOC, and the study is open with 71 patients enrolled at the time of abstract submission.
- Avastin (bevacizumab) / Roche
[VIRTUAL] ENGOT-ov54/Swiss-GO-2/MATAO including LOGOS (Low-Grade Ovarian cancer Sub-study): MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer—A randomized, double-blinded, placebo-controlled, multicenter phase III Trial. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2212;
P3
In total, 528 pts will be randomly assigned to letrozole or placebo for 5 yrs or until unacceptable toxicity, progression of underlying disease, or study discontinuation . Final analysis is planned after 5 years without interval analysis and follow-up is collected for up to 10yr and for the low-grade cohort for up to 12yr.
- tamoxifen / Generic mfg.
[VIRTUAL] Evaluating the role of aromatase inhibitors (AIs) in the treatment of endometrial stromal sarcomas (ESS). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2189;
P2
We found the ORR to be more modest than previously reported . The majority of pts had prolonged stable disease with a DCR of 58% even in stage 4 disease .
- letrozole / Generic mfg., anastrozole / Generic mfg., exemestane / Generic mfg.
[VIRTUAL] Evaluation of sensitivity to endocrine therapy index (SET2,3) for response to neoadjuvant endocrine therapy (NET) and subsequent prognosis. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1677;
Background: Patients (pts) in Cohort A of the American College of Surgeons Oncology Group Z1031 (Alliance) trial of NET for cStage II-III breast cancer were randomized to anastrozole [ANA], letrozole [LET] or exemestane [EXE] for 16-18 weeks (wks) . An exploratory analysis of Z1031 data demonstrated that the rate of pharmacodynamic suppression of proliferation by NET at 2-4 wks was greater and EFS was longer for pts with breast cancer expressing high SET2,3 disease than pts with low SET2,3.
- letrozole / Generic mfg.
[VIRTUAL] Breast Cancer Index and prediction of benefit from extended endocrine therapy based on treatment compliance: An IDEAL study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1629;
P3
Importantly, BCI (H/I)-High patients with endocrine responsive disease showed significant improvements in outcome when compliant and should be guided to continue treatment . BCI may serve as an important genomic tool to increase EET compliance and identify patients that may be candidates for increased side effect management and support to potentially improve outcomes.
- tamoxifen / Generic mfg.
[VIRTUAL] Bone safety profile of steroidal aromatase inhibitor in comparison to non-steroidal aromatase inhibitors in postmenopausal women with breast cancer: A network meta-analysis. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1625;
This NMA suggested that bone-related safety events might be lower in early BC patients treated with exemestane in comparison to non-steroidal AIs, anastrozole and letrozole . Although there was no statistical significance, further head-on studies are required to substantiate our results.
- letrozole / Generic mfg.
[VIRTUAL] Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy (ELT) in the NRG Oncology/NSABP B-42 trial. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1591;
The treatment by risk group interaction was not statistically significant for DR, but it was for DFS and BCFI . The benefit appears to be stronger in MP-LNUL than in MP-UL.
- letrozole / Generic mfg.
[VIRTUAL] Breast Cancer Index (BCI) and prediction of benefit from extended aromatase inhibitor (AI) therapy (tx) in HR+ breast cancer: NRG oncology/NSABP B-42. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1590;
P3
In time-dependent DR analyses, BCI-H/I-High pts had statistically significant benefit from ELT after 4y, while BCI-H/I-Low pts did not . Observed ELT benefit on BCFI in BCI-H/I-Low pts was primarily driven by second primary breast cancers .
- amcenestrant (SAR439859) / Sanofi, Ibrance (palbociclib) / Pfizer
[VIRTUAL] AMEERA-5: A randomized, double-blind phase III study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1399;
P3
Fulvestrant is currently the only SERD available for advanced BC but requires intramuscular administration, limiting the applied dose, exposure and receptor engagement...The study includes men, pre/peri-menopausal (with goserelin) and post-menopausal women...Biomarkers will be measured in paired tumor biopsies and cell free deoxyribonucleic acid (cfDNA) over time . Target enrolment = 1066 pts; enrolment as of 1/2021 = 33 pts.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] persevERA Breast Cancer (BC): Phase III study evaluating the efficacy and safety of giredestrant (GDC-9545) + palbociclib versus letrozole + palbociclib in patients (pts) with estrogen-receptor-positive, HER2-negative locally advanced or metastatic BC (ER+/HER2– LA/mBC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1398;
P3
Enrollment is open (first patient in: Oct 9, 2020); target recruitment is 978 pts across all sites in a global enrollment phase . After completion of the global enrollment, additional pts may be enrolled in China.
- tamoxifen / Generic mfg., fulvestrant / Generic mfg.
[VIRTUAL] Relative risk of pneumonitis or interstitial lung disease (ILD) associated with the use of cyclin-dependent kinase inhibitors (CDK4/6i): A systematic review and meta-analysis of phase 3 randomized controlled trials. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1367;
Cyclin-dependent kinase 4/6 inhibitors are associated with increased risk of any grade pneumonitis or ILD . Early detection and prompt initiation of appropriate interventions are vital to reduce the morbidity and mortality associated with CDK4/6i induced pneumonitis or ILD.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Real-world quality of life (QoL) in black, indigenous and people of color (BIPOC) treated with palbociclib (PAL) and endocrine therapy for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): A subgroup analysis from POLARIS. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1366;
P=N/A
In this subgroup analysis, PAL had no significant adverse impact on QOL in BIPOC with HR+/HER2– ABC, consistent with previous findings from the total POLARIS study population . Pfizer (NCT03280303).
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Phase I safety and efficacy study of autophagy inhibition with hydroxychloroquine to augment the antiproliferative and biological effects of preoperative palbociclib plus letrozole for estrogen receptor-positive, HER2-negative metastatic breast cancer (MBC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1362;
P1/2
The RP2D of HCQ is 800 mg/day with continuous dosing palbociclib at 75 mg/day and letrozole at 2.5 mg/day . The phase 2 trial will proceed in the neoadjuvant setting, with Ki67 proliferative index response as the primary endpoint.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] On-treatment derived neutrophil-to-lymphocyte ratio and response to palbociclib and letrozole: Analysis of a multicenter retrospective cohort and the PALOMA-2 study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1361;
P3
The phase 2 trial will proceed in the neoadjuvant setting, with Ki67 proliferative index response as the primary endpoint. On-treatment dNLR significantly predicted treatment outcome in HR-positive, HER2-negative ABC treated with palbociclib and letrozole, allowing early prediction of treatment response with mechanistic insights.
- Piqray (alpelisib) / Novartis
[VIRTUAL] Impact of duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy on alpelisib (ALP) benefit in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2–), PIK3CA-mutated advanced breast cancer (ABC) from BYLieve. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1355;
P2
Primary analyses of Cohorts A and B from the phase 2 BYLieve study demonstrated that ALP + endocrine therapy (ET; fulvestrant [FUL] or letrozole [LET]) is effective and safe in pts with HR+, HER2–PIK3CA-mutated ABC with prior CDK4/6i therapy . This analysis demonstrates that the benefit and safety profiles of ALP + ET are similar in pts with HR+, HER2–PIK3CA-mutated ABC who achieved relatively shorter duration of disease control with prior CDK4/6i vs those with longer duration of disease control, and suggests that ALP overcomes acquired resistance to CDK4/6i in these pts.
- fulvestrant / Generic mfg.
[VIRTUAL] Resistance to CDK4/6 inhibitors (CDK4/6i): The clinical usefulness of liquid biopsy in metastatic breast cancer (mBC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1348;
Despite the study’s limitations, our data suggest mutKRAS ctDNA status leads to CDK4/6i resistance acquisition within 6 months from the detection and provide critical information for the prediction of therapeutic responses in mBC . Monitoring KRAS status with liquid biopsy, we could predict who will take advantage from CDK4/6i, decreasing wastes of resources ensuring the best patients’ quality of life.
- fulvestrant / Generic mfg.
[VIRTUAL] The association of HER2 low expression with the efficacy of CDK4/6 inhibitor in hormone receptor positive HER2 negative metastatic breast cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1347;
In patients with ER+ HER2- MBC treated with CDK4/6 inhibitors, HER2-low expression was associated with an inferior PFS, and may serve as a potential marker candidate for CDK4/6 inhibitor efficacy . As novel anti-HER2 antibody-drug conjugates demonstrated efficacy in HER2-low expressing MBC, coupled with the emerging evidence for the combination of CDK4/6 inhibitors with anti-HER2 agents, this HER2-low expression subgroup warrants prospective evaluations in future trials.
- dalpiciclib (SHR6390) / Jiangsu Hengrui Medicine, Irene (pyrotinib) / Jiangsu Hengrui Medicine, Herceptin (trastuzumab) / Roche
[VIRTUAL] Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor SHR6390 combined with pyrotinib and letrozole in patients with human epidermal growth factor receptor 2-positive (HER2+), hormone receptor positive (HR+) metastatic breast cancer (MBC): Phase Ib study results. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1330;
P1/2
Data from phase Ib showed the triplet combination of pyrotinib, letrozole, and SHR6390 had an acceptable safety profile and encouraging preliminary efficacy, potentially offering a chemotherapy sparing treatment option for patients with HR+/HER2+ MBC . Enrollment on phase II is ongoing.
- | sacibertinib (Hemay022) / Tianjin Hemay Pharma
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov) - Apr 28, 2021
P1, N=48, Recruiting, Sponsor: Tianjin Hemay Pharmaceutical Co.,Ltd
Enrollment on phase II is ongoing. Trial completion date: Jul 2021 --> Dec 2022 | Trial primary completion date: Feb 2021 --> May 2022
- || letrozole / Generic mfg.
Clinical, Journal: Efficacy and safety of controlled ovarian stimulation using GnRH antagonist protocols for emergency fertility preservation in young women with breast cancer-a prospective nationwide Swedish multicenter study. (Pubmed Central) - Apr 28, 2021
In women with BC undergoing COS aiming at egg/embryo cryopreservation, letrozole-based protocols and those randomly started were equally effective compared with conventional COS, and the overall survival was similar between the women that proceeded to FP and those who did not...reports grants from Amgen, AstraZeneca, Pfizer, Roche, Sanofi-Aventis and Merck, outside the submitted work, and payment from UpToDate to Asklepios Medicine HB for a chapter on BC prediction and prognostication. All the other authors have no competing interests to report.
- ||| 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
All the other authors have no competing interests to report. Recruiting --> Active, not recruiting
- || letrozole / Generic mfg., clomifene citrate / Generic mfg.
Clinical, Journal: Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial. (Pubmed Central) - Apr 28, 2021
Dr Zhang reports grants from NIH during the conduct of the study and support from Shangdong University outside the submitted work. n/a.
- || tamoxifen / Generic mfg., everolimus / Generic mfg.
Clinical, P2 data, Journal: Final results of the randomized phase 2 LEO trial and bone protective effects of everolimus for premenopausal hormone receptor-positive, HER2-negative metastatic breast cancer. (Pubmed Central) - Apr 28, 2021
The phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases...Patients who were exposed to or progressed on tamoxifen as adjuvant/palliative treatments were randomly assigned (2:1) to the EVE (leuprorelin+LET+EVE, n=92) or LET (leuprorelin+LET, n=45) arm...EVE+LET with ovarian suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effects in the overall study population. However, these clinical benefits did not translate into an OS benefit.
- || letrozole / Generic mfg.
Clinical, Journal: A case of letrozole induced mania. (Pubmed Central) - Apr 27, 2021
Resisting formal treatment for some 3 years, a primary treatment was attempted with a series of antidepressants and antipsychotics including citalopram and haloperidol with marginal tolerability and success. She was later stabilized on lithium but became nonadherent and went on to treatment with lamotrigine, which resulted in the development of Stevens-Johnson syndrome.
- tamoxifen / Generic mfg.
[VIRTUAL] A Descriptive, Correlational, Secondary Analysis of Rates and Determinants of Oral Endocrine Therapy Adherence in Women With Breast Cancer: Research Protocol () - Apr 24, 2021 - Abstract #ONS2021ONS_492;
Discussion and Implications: Determining rates and multi-level determinants of OET adherence will be the first step in developing and testing interventions to improve OET adherence with breast cancer, which has the potential to decrease morbidity and mortality and increase QOL. Emphasizing multi-level influences is critical for nursing research because nurses are uniquely positioned to assist in changing medication adherence behaviors in women with breast cancer, so quality of life and outcomes are improved.
- | metformin / Generic mfg., letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome (clinicaltrials.gov) - Apr 23, 2021
P3, N=80, Recruiting, Sponsor: Assiut University
Emphasizing multi-level influences is critical for nursing research because nurses are uniquely positioned to assist in changing medication adherence behaviors in women with breast cancer, so quality of life and outcomes are improved. Trial completion date: Mar 2019 --> Mar 2022 | Trial primary completion date: Dec 2018 --> Dec 2021
- | letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome (clinicaltrials.gov) - Apr 23, 2021
P3, N=150, Recruiting, Sponsor: Assiut University
Trial completion date: Mar 2019 --> Mar 2022 | Trial primary completion date: Dec 2018 --> Dec 2021 Trial completion date: Jun 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Sep 2021
- ||| risovalisib (CYH33) / HaiHe Biopharma
New P1 trial, Combination therapy, Metastases: Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) - Apr 23, 2021
P1, N=228, Not yet recruiting, Sponsor: Haihe Biopharma Co., Ltd.