- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
[VIRTUAL] CDK4/6i adjustment & tumour response in the COVID-19 era () - Mar 9, 2021 - Abstract #ESMOBC2021ESMO_BC_262; If receiving Denosumab, this was stopped in 72.4% (n= 92)... A short interruption of CDK4/6i and continuation of endocrine treatment alone, does not appear to adversely affect tumour response from this data. Continued monitoring of this approach during subsequent pandemic waves is required together with specific outcomes of SARS-CoV-2 in the metastatic breast cancer population to ensure evidence based decision making.
- |||||||||| Ibrance (palbociclib) / Pfizer
[VIRTUAL] Letrozole and palbociclib versus third generation chemotherapy as neoadjuvant treatment in luminal breast cancer: Survival results of the UNICANCER-NeoPAL study (Channel 2) - Mar 9, 2021 - Abstract #ESMOBC2021ESMO_BC_132; P2 If RCB 0/1 in ≥ 3/39 pts, the combination will be considered worthy for further investigation. Postmenopausal women with ER-positive, HER2-negative, Prosigna®-defined luminal B, or luminal A and node-positive, stage II-III BC, were randomly assigned to either letrozole (2.5 mg daily) and palbociclib (125 mg daily, 3 weeks/4) during 19 weeks (LETPAL), or to FEC100 (5FU 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) x3 21-day courses followed by docetaxel 100 mg/m2 x3 21-day courses (CT)... Despite its small size, NeoPAL suggests that a neoadjuvant LETPAL strategy, together with selected postoperative administration of chemotherapy, may spare chemotherapy in some pts with LBC while allowing good long-term outcomes.
- |||||||||| letrozole / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: Myo-Inositol for Infertility in PCOS (clinicaltrials.gov) - Mar 9, 2021 P=N/A, N=168, Recruiting, Postmenopausal women with ER-positive, HER2-negative, Prosigna®-defined luminal B, or luminal A and node-positive, stage II-III BC, were randomly assigned to either letrozole (2.5 mg daily) and palbociclib (125 mg daily, 3 weeks/4) during 19 weeks (LETPAL), or to FEC100 (5FU 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) x3 21-day courses followed by docetaxel 100 mg/m2 x3 21-day courses (CT)... Despite its small size, NeoPAL suggests that a neoadjuvant LETPAL strategy, together with selected postoperative administration of chemotherapy, may spare chemotherapy in some pts with LBC while allowing good long-term outcomes. Not yet recruiting --> Recruiting | Trial completion date: Jun 2021 --> Jan 2022 | Trial primary completion date: Jun 2021 --> Jan 2022
- |||||||||| Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Pfizer
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer (clinicaltrials.gov) - Mar 8, 2021 P1/2, N=42, Active, not recruiting, Not yet recruiting --> Recruiting | Trial completion date: Jun 2021 --> Jan 2022 | Trial primary completion date: Jun 2021 --> Jan 2022 Trial completion date: Mar 2021 --> Mar 2023 | Trial primary completion date: Mar 2020 --> Mar 2022
- |||||||||| letrozole / Generic mfg.
Trial initiation date: Hormone Secretion in Transgender Males (clinicaltrials.gov) - Mar 7, 2021 P4, N=26, Not yet recruiting, Trial completion date: Mar 2021 --> Mar 2023 | Trial primary completion date: Mar 2020 --> Mar 2022 Initiation date: Jan 2021 --> Jan 2022
- |||||||||| PF-06804103 / Pfizer
Trial completion date, Trial primary completion date: PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors (clinicaltrials.gov) - Mar 5, 2021 P1, N=148, Recruiting, Letrozole is a better alternative for ovulation induction in anovulatory women with PCOS as pregnancy rates are higher, time to pregnancy is shorter, and chances of multiple pregnancy are less because of high monofollicular growth. Trial completion date: Mar 2024 --> Aug 2021 | Trial primary completion date: Mar 2024 --> Aug 2021
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Enrollment open, Combination therapy, Metastases: A Study of Abemaciclib in Indian Women With Advanced Breast Cancer (clinicaltrials.gov) - Mar 4, 2021 P4, N=100, Recruiting, Trial completion date: Mar 2024 --> Aug 2021 | Trial primary completion date: Mar 2024 --> Aug 2021 Not yet recruiting --> Recruiting
- |||||||||| Kisqali (ribociclib) / Novartis
Trial completion, Enrollment change, Tumor mutational burden: LEEomic: CompLEEment-1 Canadian Correlative Sub-Study (clinicaltrials.gov) - Mar 3, 2021 P2, N=85, Completed, Trial primary completion date: Dec 2020 --> Nov 2022 Recruiting --> Completed | N=150 --> 85
- |||||||||| Ibrance (palbociclib) / Pfizer
[VIRTUAL] PALBOCICLIB CAUSING ENTERIC HYPEROXALURIA INDUCED AKI () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_680; The prognosis of hyperoxaluria is dependent on timely diagnosis, with early initiation of treatment and dietary modification important to slow progression. CONCLUSION For patients on palbociclib who develop acute kidney injury, hyperoxaluria should be considered as a differential diagnosis.
- |||||||||| letrozole / Generic mfg., erlotinib / Generic mfg.
Journal: Benzoxazole derivatives as new generation of anti-breast cancer agents. (Pubmed Central) - Feb 27, 2021 Compounds 4a, 6c and 8a showed the most potent cytotoxic activity against MDA-MB-231 cancer cells where compounds 4a and 6c were slightly less potent aromatase (ARO) inhibitors than letrozole...The benzoxazole derivatives 11c and 6c possessing amide and dithiocarbamate moieties respectively were found to be potent apoptosis-inducing anti-breast cancer agents with acceptable physicochemical properties. They exert their activity via inhibition of EGFR and ARO enzymes respectively.
- |||||||||| Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
Trial primary completion date, Tumor mutational burden, Metastases: BioItaLEE: Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (clinicaltrials.gov) - Feb 26, 2021 P3, N=287, Active, not recruiting, They exert their activity via inhibition of EGFR and ARO enzymes respectively. Trial primary completion date: Dec 2020 --> Jul 2022
- |||||||||| letrozole / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) (clinicaltrials.gov) - Feb 21, 2021 P3, N=540, Recruiting, Trial primary completion date: Jul 2023 --> Nov 2021 Not yet recruiting --> Recruiting | Trial completion date: Jul 2030 --> Oct 2030 | Trial primary completion date: Jul 2025 --> Oct 2025
- |||||||||| letrozole / Generic mfg.
Journal: Leptin-elicited PBX3 confers letrozole resistance in breast cancer. (Pubmed Central) - Feb 21, 2021 By profiling BCa cells with ectopic PBX3 expression, we revealed that PBX3 conferred letrozole resistance via transactivation of the FGFR1 signaling, and this molecular event must coordinate a synergistic transcription activation programs through interacting with MTA1-HDAC2 (metastasis associated 1-histone deacetylase 2) complex. Overall, the available data reveal a novel role of leptin/PBX3 cascade linking energy homeostasis (i.e. hyperleptinemia) and endocrine therapy failure (i.e. letrozole resistance) in BCa.
- |||||||||| letrozole / Generic mfg.
Preclinical, Journal: A Rat Model of Polycystic Ovary Syndrome with Insulin Resistance Induced by Letrozole Combined with High Fat Diet. (Pubmed Central) - Feb 20, 2021 Levels of LH/FSH, T, and TG were substantially increased (P<0.05), but levels of FINS and HOMA-IR were significantly increased (P<0.05) on Day 28 and 31 in the model groups. CONCLUSIONS This study implied that letrozole combined with a high fat diet for 27 days could induce the PCOS-IR rat model which has the characteristics of ovarian polycystic changes and endocrine and metabolic disorders.
- |||||||||| letrozole / Generic mfg.
Clinical, Journal: The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer. (Pubmed Central) - Feb 14, 2021 In all, 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI) ≥24 kg/m receiving adjuvant letrozole were randomized (enrolment ended due to funding loss)...Although loss of funding reduced sample size, we view these hypothesis generating results as compatible with our hypothesis of a potential beneficial effect of a lifestyle intervention on DFS. They provide support for completion of ongoing randomized controlled trials of the effect of lifestyle interventions in BC outcomes.
- |||||||||| letrozole / Generic mfg., tamoxifen / Generic mfg.
Clinical, Journal: Association between BMI, vitamin D, and estrogen levels in postmenopausal women using adjuvant letrozole: a prospective study. (Pubmed Central) - Feb 14, 2021 There was no observed association between markers of obesity (BMI, insulin, leptin, and CRP), serum 25-OH vitamin D levels and estradiol or estrone levels. Additionally, an increased dose of letrozole did not further reduce estradiol or estrone levels compared to the standard dose.
- |||||||||| Kisqali (ribociclib) / Novartis
Clinical, Journal: PTEN loss mediates clinical cross-resistance to CDK4/6 and PI3Kα inhibitors in breast cancer. (Pubmed Central) - Feb 13, 2021 Mechanistically, PTEN loss resulted in exclusion of p27 from the nucleus, leading to increased activation of both CDK4 and CDK2. Since PTEN loss also causes resistance to PI3Kalpha-inhibitors, currently approved in the post-CDK4/6 setting, these findings provide critical insight into how this single genetic event may cause clinical cross-resistance to multiple targeted therapies in the same patient, with implications for optimal treatment sequencing strategies.
- |||||||||| letrozole / Generic mfg.
Clinical, Journal: Trends in metabolic surgery in reproductive-age women in Australia. (Pubmed Central) - Feb 12, 2021 While the uptake of bariatric surgery is rapidly increasing, there has been a decline in the use of LOD in young women. It seems likely that other forms of care for PCOS-related anovulation resistant to clomiphene, such as the use of letrozole or in vitro fertilisation, are taking the place of LOD.
- |||||||||| Ibrance (palbociclib) / Pfizer, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - Feb 12, 2021 P2, N=22, Recruiting, It seems likely that other forms of care for PCOS-related anovulation resistant to clomiphene, such as the use of letrozole or in vitro fertilisation, are taking the place of LOD. Trial completion date: Sep 2020 --> Dec 2021 | Trial primary completion date: Sep 2020 --> Dec 2021
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