- |||||||||| megestrol / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: MEGA: A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer (clinicaltrials.gov) - Aug 15, 2019 P2, N=20, Recruiting, This study demonstrates, for the first time, the pre-clinical activity of novel systemic anti-cancer therapeutic peptides, ALM201 and AD-01, in the metastatic setting, and highlights their impact on endocrine therapy resistant CSCs; both areas of unmet clinical need. Trial completion date: Sep 2018 --> Sep 2020 | Trial primary completion date: Mar 2018 --> Mar 2020
- |||||||||| metformin / generics
Journal: Insulin Sensitizers Modulate GnRH Receptor Expression in PCOS Rats. (Pubmed Central) - Aug 9, 2019 Metformin and pioglitazone treatment improve both metabolic and reproductive parameters of PCOS including hyperinsulinemia and hyperandrogenism. LH receptor and FSH receptor mRNA expression were altered by pioglitazone and metformin treatment.
- |||||||||| Ibrance (palbociclib) / Pfizer
Clinical, Review, Journal: Palbociclib in metastatic breast cancer: current evidence and real-life data. (Pubmed Central) - Aug 9, 2019 Palbociclib in combination with endocrine therapy is a valuable emerging option for patients with HR+/HER2- advanced or metastatic breast cancer. Further investigation is needed to provide solutions for palbociclib resistance and to identify the best sequence to use for the best patient benefit with a minimal toxicity.
- |||||||||| letrozole / generics
Journal: Upregulation of PITX2 Promotes Letrozole Resistance via Transcriptional Activation of IFITM1 Signaling in Breast Cancer Cells. (Pubmed Central) - Aug 8, 2019 Further investigation is needed to provide solutions for palbociclib resistance and to identify the best sequence to use for the best patient benefit with a minimal toxicity. These results demonstrate that constitutive upregulation of PITX2/IFITM1 cascade is an intrinsic adaptive mechanism during the pathogenesis of letrozole-resistance, and modulation of PITX2/IFITM1 level using different genetic and pharmacological means would thus have a novel therapeutic potential against letrozole resistance in BCa.
- |||||||||| letrozole / generics
Preclinical, Journal: Therapeutic Efficacy of Melatonin Against Polycystic Ovary Syndrome (PCOS) Induced by Letrozole in Wistar Rat. (Pubmed Central) - Aug 8, 2019 These results demonstrate that constitutive upregulation of PITX2/IFITM1 cascade is an intrinsic adaptive mechanism during the pathogenesis of letrozole-resistance, and modulation of PITX2/IFITM1 level using different genetic and pharmacological means would thus have a novel therapeutic potential against letrozole resistance in BCa. Finding of present study showed the role of melatonin supplementation at receptor level and also suggesting a crosstalk between MT1R / MT2R via cytokine IL-2R and IL-6R resulting in modulation of ER-α receptors.
- |||||||||| letrozole / generics
Journal: Double mild stimulation and egg collection in the same cycle for management of poor ovarian responders. (Pubmed Central) - Aug 8, 2019 Finding of present study showed the role of melatonin supplementation at receptor level and also suggesting a crosstalk between MT1R / MT2R via cytokine IL-2R and IL-6R resulting in modulation of ER-α receptors. Since the intensity of stimulation in both stages was mild, this protocol can be considered a time-efficient and patient friendly regime; however, more studies are required with emphasis on its cost-effectiveness.
- |||||||||| letrozole / generics
When Breast Cancer Comes Back With Vengeance: Death Within Three Weeks Secondary to Acute Liver Failure (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_2121; Case Description/ A 63-year-old female with history of stage II HER2+ BC who underwent six cycles of neoadjuvant chemotherapy, lumpectomy, radiation, letrozole for four years, presented with one week of abdominal distension, dark urine, pale stools, and jaundice...Within three weeks of presentation, she died. This case highlight the fulminant progression of HER2+ BC causing ALF due to tumor infiltration of liver parenchyma with cessation of synthetic capacity.
- |||||||||| Kisqali (ribociclib) / Novartis
Enrollment open, Trial completion date, Trial primary completion date, Tumor mutational burden: LEEomic: CompLEEment-1 Canadian Correlative Sub-Study (clinicaltrials.gov) - Aug 7, 2019 P2, N=150, Recruiting, Trial completion date: Jul 2019 --> Jul 2020 | Trial primary completion date: Jul 2019 --> Jul 2020 Not yet recruiting --> Recruiting | Trial completion date: Apr 2019 --> Dec 2019 | Trial primary completion date: Apr 2019 --> Dec 2019
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Ibrance (palbociclib) / Pfizer
Trial initiation date, Metastases: PALVEN: Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer (clinicaltrials.gov) - Aug 7, 2019 P1b, N=36, Not yet recruiting, Not yet recruiting --> Recruiting | Trial completion date: Apr 2019 --> Dec 2019 | Trial primary completion date: Apr 2019 --> Dec 2019 Initiation date: May 2019 --> Aug 2019
- |||||||||| letrozole / Generic mfg.
Clinical, Journal, HEOR: Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years. (Pubmed Central) - Aug 3, 2019 No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.
- |||||||||| letrozole / generics
Clinical, Journal: Translation and implementation of the Australian-led PCOS guideline: clinical summary and translation resources from the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. (Pubmed Central) - Aug 1, 2019 Main recommendations: The recommendations cover the following broad areas: diagnosis, screening and risk assessment depending on life stage; emotional wellbeing; healthy lifestyle; pharmacological treatment for non-fertility indications; and assessment and treatment of infertility. Changes in management as a result of this guideline: •Diagnosis:▪when the combination of hyperandrogenism and ovulatory dysfunction is present, ultrasound examination of the ovaries is not necessary for diagnosis of PCOS in adult women;▪requires the combination of hyperandrogenism and ovulatory dysfunction in young women within 8 years of menarche, with ultrasound examination of the ovaries not recommended, owing to the overlap with normal ovarian physiology; and▪adolescents with some clinical features of PCOS, but without a clear diagnosis, should be regarded as "at risk" and receive follow-up assessment.•Screening for metabolic complications has been refined and incorporates both PCOS status and additional metabolic risk factors.•Treatment of infertility: letrozole is now first line treatment for infertility as it improves live birth rates while reducing multiple pregnancies compared with clomiphene citrate.
- |||||||||| Ibrance (palbociclib) / Pfizer
Trial primary completion date, Metastases: A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] (clinicaltrials.gov) - Aug 1, 2019 P3, N=339, Active, not recruiting, Changes in management as a result of this guideline: •Diagnosis:▪when the combination of hyperandrogenism and ovulatory dysfunction is present, ultrasound examination of the ovaries is not necessary for diagnosis of PCOS in adult women;▪requires the combination of hyperandrogenism and ovulatory dysfunction in young women within 8 years of menarche, with ultrasound examination of the ovaries not recommended, owing to the overlap with normal ovarian physiology; and▪adolescents with some clinical features of PCOS, but without a clear diagnosis, should be regarded as "at risk" and receive follow-up assessment.•Screening for metabolic complications has been refined and incorporates both PCOS status and additional metabolic risk factors.•Treatment of infertility: letrozole is now first line treatment for infertility as it improves live birth rates while reducing multiple pregnancies compared with clomiphene citrate. Trial primary completion date: Aug 2020 --> Nov 2019
- |||||||||| Navelbine oral (vinorelbine tartrate oral) / Pierre Fabre
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: VICTORIANE: A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease (clinicaltrials.gov) - Jul 25, 2019 P3, N=98, Active, not recruiting, Phase classification: P3 --> P4 Recruiting --> Active, not recruiting | N=340 --> 98 | Trial completion date: Feb 2024 --> Feb 2022 | Trial primary completion date: Feb 2019 --> Feb 2021
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