- |||||||||| letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome (clinicaltrials.gov) - Mar 25, 2019 P3, N=150, Recruiting, Phase classification: P1b/2 --> P1/2 | N=106 --> 146 | Trial completion date: Dec 2020 --> Jun 2021 Trial completion date: Feb 2019 --> Feb 2020 | Trial primary completion date: Dec 2018 --> Dec 2019
- |||||||||| Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Pfizer
Enrollment closed, Enrollment change, Combination therapy, Metastases: Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer (clinicaltrials.gov) - Mar 20, 2019 P1/2, N=25, Active, not recruiting, Everolimus plus letrozole demonstrated clinical benefit and could be a valid treatment option for postmenopausal women recurring/progressing on prior endocrine therapy. Recruiting --> Active, not recruiting | N=40 --> 25
- |||||||||| everolimus / Generic mfg., sapanisertib (TAK-228) / Takeda
Journal: Use of dual mTOR inhibitor MLN0128 against everolimus-resistant breast cancer. (Pubmed Central) - Mar 8, 2019 These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+ , HER2- ABC. Among the many signaling transduction pathways, which are altered post everolimus resistance, targeting dual mTORC1/2 is a possible option for patients who have recurrent disease from previous everolimus treatment.
- |||||||||| Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial completion date, Metastases: To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer (clinicaltrials.gov) - Mar 5, 2019 P1, N=79, Active, not recruiting, Trial completion date: Mar 2021 --> Mar 2020 Trial completion date: Dec 2018 --> Dec 2019
- |||||||||| Ibrance (palbociclib) / Pfizer
Biomarker, Enrollment closed, Combination therapy, Circulating tumor DNA, Metastases: PADA-1: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection (clinicaltrials.gov) - Mar 4, 2019 P3, N=800, Active, not recruiting, Trial completion date: Nov 2019 --> May 2021 Recruiting --> Active, not recruiting
- |||||||||| Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
Enrollment closed, Metastases: CLEE011X2107: Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer (clinicaltrials.gov) - Feb 15, 2019 P1, N=256, Active, not recruiting, Not yet recruiting --> Recruiting | Trial completion date: Dec 2019 --> Mar 2020 | Trial primary completion date: Dec 2019 --> Mar 2020 Recruiting --> Active, not recruiting
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, Irene (pyrotinib) / Jiangsu Hengrui Pharma
Enrollment open, Trial initiation date, Combination therapy, Metastases: PLEASURABLE: Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer (clinicaltrials.gov) - Feb 15, 2019 P1/2, N=32, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Dec 2018 --> Mar 2019
- |||||||||| NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date, Metastases: POLLY: ER Reactivation Therapy for Breast Cancer (clinicaltrials.gov) - Feb 8, 2019 P2, N=59, Recruiting, Not yet recruiting --> Recruiting | Initiation date: Dec 2018 --> Mar 2019 Trial completion date: Mar 2019 --> Dec 2021 | Trial primary completion date: Jan 2019 --> Aug 2021
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer (clinicaltrials.gov) - Feb 8, 2019 P2, N=48, Active, not recruiting, Trial completion date: Mar 2019 --> Dec 2021 | Trial primary completion date: Jan 2019 --> Aug 2021 Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Feb 2021 | Trial primary completion date: Jul 2019 --> Mar 2019
- |||||||||| Kisqali (ribociclib) / Novartis
Enrollment closed, Trial initiation 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) - Feb 5, 2019 P3, N=3256, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Initiation date: Nov 2016 --> Feb 2014
- |||||||||| Kisqali (ribociclib) / Novartis
Trial completion date, Trial initiation date, Trial primary completion date, Tumor mutational burden: LEEomic: CompLEEment-1 Canadian Correlative Sub-Study (clinicaltrials.gov) - Feb 1, 2019 P2, N=150, Not yet recruiting, Active, not recruiting --> Recruiting Trial completion date: Dec 2018 --> Apr 2019 | Initiation date: Oct 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) - Jan 29, 2019 P4, N=300, Recruiting, Trial primary completion date: Apr 2019 --> Apr 2018 Active, not recruiting --> Recruiting | Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> Jun 2020
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment closed, Combination therapy, Metastases: Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) - Jan 28, 2019 P4, N=242, Active, not recruiting, Active, not recruiting --> Recruiting | Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> Jun 2020 Recruiting --> Active, not recruiting
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Clinical, Journal: MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. (Pubmed Central) - Jan 27, 2019 The most frequent grade ≥ 3 adverse events in the abemaciclib versus placebo arms were neutropenia (23.9% versus 1.2%), diarrhea (9.5% versus 1.2%), and leukopenia (8.6% versus 0.6%). Abemaciclib plus a nonsteroidal AI was an effective initial treatment with an acceptable safety profile for HR+, HER2- ABC.
- |||||||||| Piqray (alpelisib) / Novartis
Enrollment change, 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) - Jan 23, 2019 P2, N=336, Recruiting, Recruiting --> Active, not recruiting | N=140 --> 8 N=160 --> 336
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