- |||||||||| Ibrance (palbociclib) / Pfizer, Aliqopa (copanlisib) / Bayer
Enrollment closed, Enrollment change: Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer (clinicaltrials.gov) - Nov 6, 2020 P2, N=10, Active, not recruiting, The addition of abemaciclib to ET demonstrated significant and clinically meaningful improvement in PFS and ORR, without new safety signals observed in this population.Trial Registration: ClinicalTrials.gov identifier: NCT02763566. Suspended --> Active, not recruiting | N=102 --> 10
- |||||||||| letrozole / Generic mfg.
[VIRTUAL] Hyperandrogenic effects on female fertility and pregnancy outcome () - Nov 5, 2020 - Abstract #ISGEI2020ISGE-I_492; Widely used stimulation protocols for patients with hyperandrogenism and PCOS are Letrozole, Сlomiphene, as well as mini stimulation with recombinant gonadotropins...In patients with PCOS, in 70% of cases, non-receptive endometrium was detected, with premature maturation in most cases. The correct assessment of patients before the IVF treatment, as well as the preliminary preparation and normalization of hormonal levels and metabolism, positively affect the amount of mature oocytes, therefore the amount of euploid embryos and the maturity of the endometrium, significantly increase the chance of pregnancy in IVF cycles.
- |||||||||| [VIRTUAL] Aromatase inhibitors (AOI) in ART () - Nov 5, 2020 - Abstract #ISGEI2020ISGE-I_488;
The aromatase inhibitors (AOI), which have letrozole as its main representative, have been increasingly used over the past years...Fertil Steril. 2005 84 Suppl 1.1O–231
- |||||||||| Herceptin (trastuzumab) / Roche, Tecentriq (atezolizumab) / Roche, Reolysin (pelareorep) / Oncolytics, Andrus Reo
[VIRTUAL] Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (virtual poster hall) - Nov 3, 2020 - Abstract #SITC2020SITC_2109; P1 Background A previous phase 2 study in metastatic breast cancer demonstrated a statistically significant improvement in overall survival (OS) in patients treated with pelareorep (pela) in combination with paclitaxel (PTX) versus PTX alone.1 Given that pela is an intravenously delivered immuno-oncolytic reovirus, we hypothesized that the OS benefit from pela + PTX may be attributed to an adaptive T cell response triggered by pela...Five cohorts will be examined: Cohort 1: HR+/HER2-neg (10 patients) receiving pelareorep + letrozole; Cohort 2: HR+/HER2-neg (10 patients) receiving pelareorep + letrozole + atezolizumab; Cohort 3: TNBC (6 patients) receiving pelareorep + atezolizumab; Cohort 4: HER2+/HR+ (6 patients) receiving pelareorep + trastuzumab + atezolizumab; Cohort 5: HER2+/HR- (6 patients) receiving pelareorep + trastuzumab + atezolizumab...In general, most of the tissue-expanded T cell clones were also seen in the peripheral blood. Conclusions Overall, these preliminary data from cohort 1 of AWARE-1 demonstrate that pela mediates priming of a T cell-based immune response that occurs both systemically and within breast cancer tissue.
- |||||||||| Herceptin (trastuzumab) / Roche, Tecentriq (atezolizumab) / Roche, Reolysin (pelareorep) / Oncolytics, Andrus Reo
[VIRTUAL] Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (virtual poster hall) - Nov 3, 2020 - Abstract #SITC2020SITC_1969; P1 Background A previous phase 2 study in metastatic breast cancer demonstrated a statistically significant improvement in overall survival (OS) in patients treated with pelareorep (pela) in combination with paclitaxel (PTX) versus PTX alone.1 Given that pela is an intravenously delivered immuno-oncolytic reovirus, we hypothesized that the OS benefit from pela + PTX may be attributed to an adaptive T cell response triggered by pela...Five cohorts will be examined: Cohort 1: HR+/HER2-neg (10 patients) receiving pelareorep + letrozole; Cohort 2: HR+/HER2-neg (10 patients) receiving pelareorep + letrozole + atezolizumab; Cohort 3: TNBC (6 patients) receiving pelareorep + atezolizumab; Cohort 4: HER2+/HR+ (6 patients) receiving pelareorep + trastuzumab + atezolizumab; Cohort 5: HER2+/HR- (6 patients) receiving pelareorep + trastuzumab + atezolizumab...In general, most of the tissue-expanded T cell clones were also seen in the peripheral blood. Conclusions Overall, these preliminary data from cohort 1 of AWARE-1 demonstrate that pela mediates priming of a T cell-based immune response that occurs both systemically and within breast cancer tissue.
- |||||||||| 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) - Nov 3, 2020 P1, N=148, Recruiting, Conclusions Overall, these preliminary data from cohort 1 of AWARE-1 demonstrate that pela mediates priming of a T cell-based immune response that occurs both systemically and within breast cancer tissue. Trial completion date: Mar 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Nov 2023
- |||||||||| tagtociclib (PF-07104091) / Pfizer
Enrollment open, Combination therapy: PF-07104091 as a Single Agent and in Combination Therapy (clinicaltrials.gov) - Nov 2, 2020 P2, N=144, Recruiting, Trial completion date: Mar 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Nov 2023 Not yet recruiting --> Recruiting
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Presentation 3 () - Oct 29, 2020 - Abstract #ESGO2020ESGO_120; These findings are reassuring on the efficacy and safety of COS with gonadotropins and letrozole and are particularly important for fertility preservation in women with hormone-sensitive cancers. Brief overview of treatment approaches for MMRp EC patients Current Chemotherapy Future IO monotherapy (dostarlimab, pembrolizumab, avelumab) AI + CDKi (letrozole + palbociclib, NGOT-EN3/NSGO-PALEO study) VEGF + IO (lenvatinib + pembrolizumab, cabozantinib + nivolumab) Chemotherapy + IO (phase 3 trials in progress: pembrolizumab + chemotherapy, atezolizumab + chemotherapy, dostarlimab + chemotherapy [RUBY]) PARPi + IO + chemotherapy (FIRST trial) Considerations associated with chemotherapy vs IO monotherapy, VEGF/IO vs chemotherapy /IO combinations, including safety, PRO (if available)
- |||||||||| letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion (clinicaltrials.gov) - Oct 28, 2020 P4, N=110, Not yet recruiting, Brief overview of treatment approaches for MMRp EC patients Current Chemotherapy Future IO monotherapy (dostarlimab, pembrolizumab, avelumab) AI + CDKi (letrozole + palbociclib, NGOT-EN3/NSGO-PALEO study) VEGF + IO (lenvatinib + pembrolizumab, cabozantinib + nivolumab) Chemotherapy + IO (phase 3 trials in progress: pembrolizumab + chemotherapy, atezolizumab + chemotherapy, dostarlimab + chemotherapy [RUBY]) PARPi + IO + chemotherapy (FIRST trial) Considerations associated with chemotherapy vs IO monotherapy, VEGF/IO vs chemotherapy /IO combinations, including safety, PRO (if available) Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Nov 2020 --> Mar 2021
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
New P2 trial, Metastases: ABIGAIL: ABemaciclib, ET (clinicaltrials.gov) - Oct 25, 2020 P2, N=160, Not yet recruiting,
- |||||||||| letrozole / Generic mfg.
Preclinical, Journal: Use of Bao Gui capsule in treatment of a polycystic ovary syndrome rat model. (Pubmed Central) - Oct 24, 2020 Letrozole was used to induce a PCOS model in rats, which were then randomly divided into four groups (n=9): Control, Model, high‑dose BGC (BGC‑H) and low‑dose BGC (BGC‑L) group...BGC also effectively reduced the level of IL‑6 and TNF‑α, and the expression of IKKβ, NF‑κB and SOCS3 in the hypothalamus of PCOS model rats. These results suggest that BGC may effectively improve hyperandrogenism, insulin resistance, endometrial receptivity and the low‑grade chronic inflammation in the hypothalamus.
- |||||||||| Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
Phase classification, Metastases: CLEE011X2107: Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (clinicaltrials.gov) - Oct 23, 2020 P1/2, N=256, Active, not recruiting, These results suggest that BGC may effectively improve hyperandrogenism, insulin resistance, endometrial receptivity and the low‑grade chronic inflammation in the hypothalamus. Phase classification: P1 --> P1/2
- |||||||||| letrozole / Generic mfg.
Trial initiation date: Myo-Inositol for Infertility in PCOS (clinicaltrials.gov) - Oct 19, 2020 P=N/A, N=168, Not yet recruiting, Recruiting --> Active, not recruiting Initiation date: Jul 2020 --> Nov 2020
- |||||||||| 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) - Oct 12, 2020 P1, N=148, Recruiting, N=48 --> 26 | Trial completion date: Dec 2021 --> Sep 2020 | Recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Aug 2020; Futility Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: May 2022 --> Mar 2023
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