- |||||||||| Trial completion date, Trial primary completion date, Combination therapy, Metastases: BOLERO-5: A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (clinicaltrials.gov) - Oct 2, 2018
P2, N=160, Recruiting, Trial completion date: Dec 2019 --> Mar 2019 | Trial primary completion date: Dec 2019 --> Mar 2019 Trial completion date: Sep 2021 --> Mar 2021 | Trial primary completion date: Dec 2019 --> Jun 2019
- |||||||||| letrozole / Generic mfg.
Trial primary completion date, Combination therapy: Study of Letrozole in Recurrent Gliomas (clinicaltrials.gov) - Oct 1, 2018 P1, N=12, Recruiting, Trial completion date: Sep 2021 --> Mar 2021 | Trial primary completion date: Dec 2019 --> Jun 2019 Trial primary completion date: Apr 2018 --> Apr 2019
- |||||||||| Herceptin (trastuzumab) / Roche, trastuzumab/pertuzumab (EG13084) / EirGenix, Perjeta (pertuzumab) / Roche
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: NEOADAPT: NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer (clinicaltrials.gov) - Sep 28, 2018 P2, N=7, Active, not recruiting, Trial primary completion date: Apr 2018 --> Apr 2019 Recruiting --> Active, not recruiting | N=32 --> 7 | Trial completion date: Jul 2018 --> Dec 2018 | Trial primary completion date: Jul 2018 --> Dec 2018
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Enrollment closed, Metastases: MONARCH plus: A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (clinicaltrials.gov) - Sep 20, 2018 P3, N=450, Active, not recruiting, Recruiting --> Active, not recruiting | N=32 --> 7 | Trial completion date: Jul 2018 --> Dec 2018 | Trial primary completion date: Jul 2018 --> Dec 2018 Recruiting --> Active, not recruiting
- |||||||||| Trial completion date, Trial primary completion date, Combination therapy, Metastases: BOLERO-5: A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (clinicaltrials.gov) - Sep 19, 2018
P2, N=160, Recruiting, Active, not recruiting --> Completed Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Jul 2019 --> Dec 2019
- |||||||||| letrozole / Generic mfg., tamoxifen / Generic mfg., everolimus / Generic mfg.
Trial primary completion date, Metastases: Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer (clinicaltrials.gov) - Sep 18, 2018 P2, N=74, Active, not recruiting, Not yet recruiting --> Recruiting | Initiation date: Dec 2017 --> Mar 2018 Trial primary completion date: Jun 2017 --> Jan 2018
- |||||||||| Herceptin (trastuzumab) / Roche, trastuzumab/pertuzumab (EG13084) / EirGenix, Perjeta (pertuzumab) / Roche
Trial completion, Trial completion date, Trial primary completion date: PER-ELISA: Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy (clinicaltrials.gov) - Sep 18, 2018 P2, N=64, Completed, N=253 --> 110 Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> Jan 2018 | Trial primary completion date: Oct 2018 --> Jan 2018
- |||||||||| letrozole / Generic mfg.
Journal: Orbital fat regeneration following hormonal treatment of metastatic breast carcinoma. (Pubmed Central) - Sep 2, 2018 Treatment with an aromatase inhibitor (letrozole) resulted in tumor regression and orbital fat restoration with a corresponding improvement in orbital volume and enophthalmos on clinical exam...This case illustrates the resilience of orbital soft tissues and ability of orbital fat to regenerate in face of breast cancer metastasis. We hypothesize that endocrine monotherapy, and avoidance of radiation therapy, allowed for differentiation of remaining orbital stem cells, and facilitated the fat regenerative process.
- |||||||||| Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
Enrollment open, 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) - Aug 31, 2018 P3, N=350, Recruiting, We hypothesize that endocrine monotherapy, and avoidance of radiation therapy, allowed for differentiation of remaining orbital stem cells, and facilitated the fat regenerative process. Not yet recruiting --> Recruiting
- |||||||||| taselisib (GDC-0032) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer (clinicaltrials.gov) - Aug 21, 2018 P1/2, N=724, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Jul 2022 | Trial primary completion date: Nov 2022 --> Jul 2022
- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg., exemestane / Generic mfg.
Trial completion date: Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole (clinicaltrials.gov) - Aug 3, 2018 P=N/A, N=44, Active, not recruiting, Recruiting --> Active, not recruiting | Phase classification: PN/A --> P1 Trial completion date: Dec 2017 --> Dec 2018
- |||||||||| Herceptin (trastuzumab) / Roche, trastuzumab/pertuzumab (EG13084) / EirGenix, Perjeta (pertuzumab) / Roche
Trial completion date, Trial primary completion date: NEOADAPT: NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer (clinicaltrials.gov) - Jul 27, 2018 P2, N=32, Recruiting, Trial completion date: Jul 2018 --> Jul 2019 | Trial primary completion date: Jul 2018 --> Jul 2019 Trial completion date: Apr 2018 --> Jul 2018 | Trial primary completion date: Apr 2018 --> Jul 2018
- |||||||||| Herceptin (trastuzumab) / Roche, trastuzumab/pertuzumab (EG13084) / EirGenix, Perjeta (pertuzumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: PER-ELISA: Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy (clinicaltrials.gov) - Jul 20, 2018 P2, N=68, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Jun 2020 | Trial primary completion date: Feb 2018 --> Dec 2019 Recruiting --> Active, not recruiting | Trial completion date: Dec 2017 --> Dec 2018 | Trial primary completion date: Oct 2017 --> Oct 2018
- |||||||||| Kisqali (ribociclib) / Novartis
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: MONALEESA-7: Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - Jul 18, 2018 P3, N=660, Active, not recruiting, Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Sep 2018 --> Sep 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2018 --> Aug 2017
- |||||||||| Ibrance (palbociclib) / Pfizer, dinaciclib (PS-095760) / Ligand, Merck (MSD)
Journal: Cytoplasmic Cyclin E Mediates Resistance to Aromatase Inhibitors in Breast Cancer. (Pubmed Central) - Jul 18, 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2018 --> Aug 2017 Collectively, these findings suggest that cell cycle deregulation by LMW-E mediates resistance to AIs and a combination of CDK2 inhibitors and AIs may be an effective treatment in patients with HR-positive tumors that express LMW-E.
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