SOLAR-1: A phase III study of alpelisib + fulvestrant in men and postmenopausal women with HR+/HER2– advanced breast cancer (BC) progressing on or after prior aromatase inhibitor therapy.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. TPS618-TPS618 ◽  
Author(s):  
Fabrice Andre ◽  
Mario Campone ◽  
Eva M. Ciruelos ◽  
Hiroji Iwata ◽  
Sibylle Loibl ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Aromatase Inhibitor ◽  
Postmenopausal Women ◽  
Inhibitor Therapy ◽  
Advanced Breast ◽  
Phase Iii ◽  
Aromatase Inhibitor Therapy ◽  
Phase Iii Study

scholarly journals Comparison of Recurrence Rates in Patients with Locally Advanced Breast Cancer after Mastectomy and Received Aromatase Inhibitor Therapy with Steroids and Nonsteroids

2021 ◽  
Vol 5 (10) ◽  
pp. 945-948
Author(s):  
I Ketut Yante ◽  
Desak Gede Agung Suprabawati ◽  
Iskandar Ali
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Aromatase Inhibitor ◽  
Aromatase Inhibitors ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Inhibitor Therapy ◽  
Advanced Breast ◽  
Aromatase Inhibitor Therapy ◽  
Risk Of Recurrence

Introduction. Breast cancer is a problem that is still faced throughout the world. The incidence of cancer in Indonesia is at number 8 in Southeast Asia. The incidence of breast cancer in women is 42.1 per 100,000 population. Aromatase inhibitors are hormonal therapy used in postmenopausal breast cancer with positive ER and/or positive PR. The third generation aromatase inhibitors are divided into 2 categories, namely non-steroidal agents that are reversible and steroid agents that are irreversible. Based on existing studies, there are no consistent research results regarding the incidence of recurrence after aromatase inhibitor therapy, both steroids and non-steroidal. Methods. This study is an analytical observational study with a retrospective cross-sectional design using secondary data from medical records. The research was carried out at the Surgical Clinic of RSUD dr. Soetomo Surabaya on October 1, 2020 until the end with the subject of LABC patients at POSA Surgery RSUD Dr. Soetomo who has undergone mastectomy and radiotherapy and has received adjuvant hormonal aromatase inhibitor therapy for 2 years from January 2018 to January 2020. Results. In the nonsteroidal aromatase inhibitor group, 18 subjects (60%) experienced recurrence and 16 subjects in the steroid aromatase inhibitor group (32%) with an OR of 0.314 (0.12-0.81; p=0.014. Based on the results of multivariate analysis, it was found that the increased risk of recurrence was significantly affected only by the administration of aromatase inhibitor p= 0.052 Conclusion. Women with locally advanced breast cancer after mastectomy who received aromatase inhibitor steroid therapy had a 0.314 times lower risk of recurrence than those who received non-steroidal aromatase inhibitor therapy.

scholarly journals Comparison of Recurrence Rates in Patients with Locally Advanced Breast Cancer after Mastectomy and Received Aromatase Inhibitor Therapy with Steroids and Nonsteroids

2021 ◽  
Vol 5 (4) ◽  
pp. 882-885
Author(s):  
I Ketut Yante ◽  
Desak Gede Agung Suprabawati ◽  
Iskandar Ali
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Aromatase Inhibitor ◽  
Aromatase Inhibitors ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Inhibitor Therapy ◽  
Advanced Breast ◽  
Aromatase Inhibitor Therapy ◽  
Risk Of Recurrence

Introduction. Breast cancer is a problem that is still faced throughout the world. The incidence of cancer in Indonesia is at number 8 in Southeast Asia. The incidence of breast cancer in women is 42.1 per 100,000 population. Aromatase inhibitors are hormonal therapy used in postmenopausal breast cancer with positive ER and/or positive PR. The third generation aromatase inhibitors are divided into 2 categories, namely non-steroidal agents that are reversible and steroid agents that are irreversible. Based on existing studies, there are no consistent research results regarding the incidence of recurrence after aromatase inhibitor therapy, both steroids and non-steroidal. Methods. This study is an analytical observational study with a retrospective cross-sectional design using secondary data from medical records. The research was carried out at the Surgical Clinic of RSUD dr. Soetomo Surabaya on October 1, 2020 until the end with the subject of LABC patients at POSA Surgery RSUD Dr. Soetomo who has undergone mastectomy and radiotherapy and has received adjuvant hormonal aromatase inhibitor therapy for 2 years from January 2018 to January 2020. Results. In the nonsteroidal aromatase inhibitor group, 18 subjects (60%) experienced recurrence and 16 subjects in the steroid aromatase inhibitor group (32%) with an OR of 0.314 (0.12-0.81; p=0.014. Based on the results of multivariate analysis, it was found that the increased risk of recurrence was significantly affected only by the administration of aromatase inhibitor p= 0.052 Conclusion. Women with locally advanced breast cancer after mastectomy who received aromatase inhibitor steroid therapy had a 0.314 times lower risk of recurrence than those who received non-steroidal aromatase inhibitor therapy.

scholarly journals MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2– advanced breast cancer: the multinational randomized phase III study

2020 ◽  
Vol 12 ◽  
pp. 175883592096392
Author(s):  
Qing Yuan Zhang ◽  
Tao Sun ◽  
Yong Mei Yin ◽  
Hui Ping Li ◽  
Min Yan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Hazard Ratio ◽  
Advanced Breast ◽  
Phase Iii ◽  
Meaningful Improvement ◽  
Measurable Disease ◽  
Phase Iii Study

Aim: To compare the efficacy, safety, and tolerability of abemaciclib plus endocrine therapy (ET) versus ET alone in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from China, Brazil, India, and South Africa. Methods: This randomized, double-blind, phase III study was conducted between 9 December 2016 and 29 March 2019. Postmenopausal women with HR-positive, HER2-negative ABC with no prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) received abemaciclib (150 mg twice daily) or placebo plus: anastrozole (1 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg per label) (cohort B). The primary endpoint was progression-free survival (PFS) in cohort A, analyzed using the stratified log-rank test. Secondary endpoints were PFS in cohort B (key secondary endpoint), objective response rate (ORR), and safety. This interim analysis was planned after 119 PFS events in cohort A. Results: In cohort A, 207 patients were randomly assigned to the abemaciclib arm and 99 to the placebo arm. Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346–0.719; p = 0.0001). ORR was 65.9% in the abemaciclib arm and 36.1% in the placebo arm ( p < 0.0001, measurable disease population). In cohort B, 104 patients were randomly assigned to the abemaciclib arm and 53 to the placebo arm. Abemaciclib significantly improved PFS versus placebo (median: 11.5 versus 5.6 months; hazard ratio 0.376; 95% CI 0.240–0.588; p < 0.0001). ORR was 50.0% in the abemaciclib arm and 10.5% in the placebo arm ( p < 0.0001, measurable disease population). The most frequent grade ⩾3 adverse events in the abemaciclib arms were neutropenia, leukopenia, and anemia (both cohorts), and lymphocytopenia (cohort B). Conclusion: 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.

AMEERA-5: A randomized, double-blind phase III study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS1104-TPS1104
Author(s):  
Aditya Bardia ◽  
Javier Cortes ◽  
Sara A. Hurvitz ◽  
Suzette Delaloge ◽  
Hiroji Iwata ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Phase I ◽  
Advanced Breast Cancer ◽  
Progression Free Survival ◽  
Advanced Breast ◽  
Phase Iii ◽  
Double Blind ◽  
Free Survival ◽  
Phase Iii Study

TPS1104 Background: Selective estrogen receptor degraders (SERDs) block estrogen receptor (ER) associated signaling and have created interest for treating patients (pts) with advanced ER+ breast cancer (BC). Fulvestrant is currently the only SERD available for advanced BC but requires intramuscular administration, limiting the applied dose, exposure and receptor engagement. Amcenestrant (SAR439859) is an oral SERD that binds with high affinity to both wild-type and mutant ER, blocking estradiol binding and promoting up to 98% ER degradation in preclinical studies. In the phase I AMEERA-1 study of pretreated pts with ER+/HER2- advanced BC, amcenestrant 150–600 mg once daily (QD) showed a mean ER occupancy of 94% with plasma concentrations > 100 ng/mL and a favorable safety profile (Bardia, 2019; data on file). Combination therapy with amcenestrant + palbociclib (palbo) was also evaluated as part of this ongoing phase I study. CDK 4/6 inhibitors (CDK4/6i) combined with an aromatase inhibitor (AI), the gold standard for first line treatment for advanced breast cancer, prolong progression free survival (PFS) in pts with no prior treatment for ER+/HER2- advanced BC, but OS benefit has not been shown yet in postmenopausal pts. There remains a clinical need for more effective treatments in this setting. Methods: AMEERA-5 (NCT04478266) is an ongoing, prospective, randomized, double-blind phase III study comparing the efficacy and safety of amcenestrant + palbo with that of letrozole + palbo in pts with advanced, locoregional recurrent or metastatic ER+/HER2- BC who have not received prior systemic therapy for advanced disease. The study includes men, pre/peri-menopausal (with goserelin) and post-menopausal women. Pts with progression during or within 12 months of (neo)adjuvant endocrine therapy using any of the following agents are excluded: AI, selective estrogen receptor modulators, CDK4/6i. Pts are randomized 1:1 to either continuous amcenestrant 200 mg or letrozole 2.5 mg QD orally with matching placebos; both combined with palbo 125 mg QD orally (d1–21 every 28-d cycle). Randomization is stratified according to disease type (de novo metastatic vs recurrent disease), the presence of visceral metastasis, and menopausal status. The primary endpoint is investigator assessed progression free survival (PFS) (RECIST v1.1). Secondary endpoints are overall survival, PFS2, objective response rate, duration of response, clinical benefit rate, pharmacokinetics of amcenestrant and palbo, health-related quality of life, time to chemotherapy, and safety. Biomarkers will be measured in paired tumor biopsies and cell free deoxyribonucleic acid (cfDNA) over time. Target enrolment = 1066 pts; enrolment as of 1/2021 = 33 pts. Bardia A, et al., J Clin Oncol. 2019; 37 (15 suppl):1054 Clinical trial information: NCT04478266 .

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