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123 Trials |
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123 Trials |  |
2738 News |  |
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- || Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date: A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov) - Nov 6, 2019
P1b, N=198, Recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Dec 2021 --> Oct 2022 | Trial primary completion date: Mar 2020 --> Apr 2021
- | Zoladex (goserelin acetate implant) / AstraZeneca, TerSera Therap, Arimidex (anastrozole) / AstraZeneca, Remedica
Clinical, Journal, BRCA Biomarker: Chemoprevention in BRCA1 mutation carriers (CIBRAC): protocol for an open allocation crossover feasibility trial assessing mechanisms of chemoprevention with goserelin and anastrozole versus tamoxifen and acceptability of treatment. (Pubmed Central) - Oct 31, 2019
P2
A copy of the results will be offered to the participants and be made available to patient support groups. EudraCT: 2016-001087-11; Pre-results.
- |||| Ibrance (palbociclib) / Pfizer
Trial completion date, Trial primary completion date: PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) - Oct 30, 2019
P3, N=496, Recruiting, Sponsor: Alliance Foundation Trials, LLC.
EudraCT: 2016-001087-11; Pre-results. Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Oct 2020 --> May 2021
- | Arimidex (anastrozole) / AstraZeneca, Remedica, Tamoxis (tamoxifen) / Bioprofarma
Journal: The Impact of Perioperative Hormonal Therapy for Breast Cancer on Transverse Rectus Abdominis Myocutaneous Flap Abdominal Complications. (Pubmed Central) - Oct 30, 2019
Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Oct 2020 --> May 2021 Hormonal therapy is a useful adjunct for chemoprevention in breast cancer; however, use of letrozole in patients undergoing reconstruction with pedicled TRAM can lead to increase in certain complication rates.
- || xentuzumab (BI-836845) / Boehringer Ingelheim
Trial completion date, Trial primary completion date, Combination therapy, Metastases: This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer (clinicaltrials.gov) - Oct 29, 2019
P1, N=148, Recruiting, Sponsor: Boehringer Ingelheim
Hormonal therapy is a useful adjunct for chemoprevention in breast cancer; however, use of letrozole in patients undergoing reconstruction with pedicled TRAM can lead to increase in certain complication rates. Trial completion date: Nov 2021 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Nov 2021
- | Arimidex (anastrozole) / AstraZeneca, Remedica
Clinical, Journal: Efficacy of Anastrozole after Tamoxifen in Early Breast Cancer Patients with Chemotherapy-Induced Ovarian Function Failure. (Pubmed Central) - Oct 29, 2019
P3
The residual 5-year rate for distant recurrence-free survival was 76.9% for women with OFR and 92.1% for women without OFR, and for 5-year overall survival 80.8% and 94.4%, respectively. Women with CIOFF receiving anastrozole may be at increased risk of disease recurrence if experiencing OFR.
- | Arimidex (anastrozole) / AstraZeneca, Remedica
Retrospective data, Journal: Comparison of Changes in the Lipid Profiles of Eastern Chinese Postmenopausal Women With Early-Stage Breast Cancer Treated With Different Aromatase Inhibitors: A Retrospective Study. (Pubmed Central) - Oct 29, 2019
As a small-size retrospective study, our data do not support a judgment about whether one AI or another carries more or less risk in terms of lipid disorders in eastern Chinese breast cancer patients. The exact effects need further randomized, controlled trials to investigate.
- ||| Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Trial completion date: Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov) - Oct 27, 2019
P3, N=270, Recruiting, Sponsor: Prof. W. Janni
The exact effects need further randomized, controlled trials to investigate. Trial completion date: Sep 2021 --> Jun 2023
- | Arimidex (anastrozole) / AstraZeneca, Remedica
Clinical, P2 data, Journal: PARAGON: A Phase II study of anastrozole in patients with estrogen receptor-positive recurrent/metastatic low-grade ovarian cancers and serous borderline ovarian tumors. (Pubmed Central) - Oct 27, 2019
Trial completion date: Sep 2021 --> Jun 2023 Anastrozole was associated with a CBR of 61% of patients with recurrent ER-positive and/or PR-positive LGOC or SBOT for at least 6 months with acceptable toxicity.
- | New P2/3 trial, HEOR: EUROPA: ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ?70 Years Early Stage Breast Cancer (clinicaltrials.gov) - Oct 21, 2019
P2/3, N=600, Not yet recruiting, Sponsor: Azienda Ospedaliero-Universitaria Careggi
- | Opdivo (nivolumab) / BMS
Enrollment open: CheckMate 7A8: A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (clinicaltrials.gov) - Oct 15, 2019
P2, N=268, Recruiting, Sponsor: Bristol-Myers Squibb
Anastrozole was associated with a CBR of 61% of patients with recurrent ER-positive and/or PR-positive LGOC or SBOT for at least 6 months with acceptable toxicity. Not yet recruiting --> Recruiting
- | Trial completion date, Trial primary completion date, Metastases: Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane (clinicaltrials.gov) - Oct 14, 2019
P=N/A, N=175, Active, not recruiting, Sponsor: VU University Medical Center
Not yet recruiting --> Recruiting Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jan 2019 --> Jan 2021
- |||| Clinical: Drug induce SCLE (DI-SCLE) is a separate entity from drug induced lupus (DIL) 6-20% SCLE may be drug- induced Induced Assc with individuals with + Ro Meds assc: HCTZ, terbinafine, TNFi, CaChBlkr, PPIs, beta blkr, anastrozole, statins, doxycycline, citalopram @RheumNow (Twitter) - Oct 13, 2019
- | everolimus / Generic mfg.
Retrospective data, Journal: Progression-free survival with endocrine-based therapies following progression on non-steroidal aromatase inhibitor among postmenopausal women with HR+/HER2- metastatic breast cancer: a network meta-analysis. (Pubmed Central) - Oct 9, 2019
Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jan 2019 --> Jan 2021 Postmenopausal women with HR+/HER2- mBC who have previously failed an NSAI and received palbociclib+fulvestrant, everolimus+AI or everolimus+fulvestrant had longer PFS compared to those who received fulvestrant or AI alone.
- | anastrozole / Generic mfg., fulvestrant / Generic mfg.
Trial primary completion date: ALTERNATE: Fulvestrant And/or Anastrozole in Treating Postmenopausal Patients with Stage II-III Breast Cancer Undergoing Surgery (clinicaltrials.gov) - Oct 4, 2019
P3, N=1473, Active, not recruiting, Sponsor: Alliance for Clinical Trials in Oncology
Postmenopausal women with HR+/HER2- mBC who have previously failed an NSAI and received palbociclib+fulvestrant, everolimus+AI or everolimus+fulvestrant had longer PFS compared to those who received fulvestrant or AI alone. Trial primary completion date: Apr 2020 --> Aug 2025
- | Vesanoid (tretinoin) / Roche
New P2 trial, Combination therapy: Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer (clinicaltrials.gov) - Oct 2, 2019
P2, N=112, Recruiting, Sponsor: Mario Negri Institute for Pharmacological Research
- | aspirin / Generic mfg., celecoxib oral / Generic mfg.
Clinical, Journal: Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor-Treated Patients: CCTG MA.27. (Pubmed Central) - Oct 2, 2019
Random assignment to short-term (≤18 months) celecoxib as well as use of low-dose aspirin showed no effect on DDFS and EFS in multivariable analysis. Low-dose aspirin increased "all-cause" mortality, presumably because of higher preexisting cardiovascular risks.
- | Lynparza (olaparib) / Merck (MSD), AstraZeneca
Clinical, P1 data, PK/PD data, Journal: Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours. (Pubmed Central) - Sep 28, 2019
P1
Low-dose aspirin increased "all-cause" mortality, presumably because of higher preexisting cardiovascular risks. The combination of olaparib and either anastrozole, letrozole or tamoxifen was generally well tolerated, with no clinically relevant PK interactions identified.
- | Arimidex (anastrozole) / AstraZeneca, Remedica, Tamoxis (tamoxifen) / Bioprofarma, Evomate (raloxifene hydrochloride) / Shreya Life Sciences
Clinical, Review, Journal: Medication Use for the Risk Reduction of Primary Breast Cancer in Women: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. (Pubmed Central) - Sep 27, 2019
Tamoxifen, raloxifene, and aromatase inhibitors were associated with lower risk of primary invasive breast cancer in women but also were associated with adverse effects that differed between medications. Risk stratification methods to identify patients with increased breast cancer risk demonstrated low accuracy.
- | Enrollment open: Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) (clinicaltrials.gov) - Sep 25, 2019
P4, N=218, Recruiting, Sponsor: Ottawa Hospital Research Institute
Risk stratification methods to identify patients with increased breast cancer risk demonstrated low accuracy. Not yet recruiting --> Recruiting
- Arimidex (anastrozole) / AstraZeneca, Remedica
ESR1 mutations are not a mechanism of primary resistance to aromatase inhibitors in ER-positive breast cancer treated with neoadjuvant endocrine therapy (Hall 1 - Poster Session 2) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1951;
Among these patients, the PEPI Score ranged from 0 to 3 in 70% (70/100), and 30% (30/100) had a PEPI Score of 4 or more and were selected. 23 patients were included in the analysis (6 did not consent or were lost to follow-up, and one was HER2-positive).
- Kisqali (ribociclib) / Novartis
Pharmacokinetic assessment of ribociclib, an oral CDK4/6 inhibitor, and the interaction with endocrine therapy partners in patients with advanced breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1877;
P1, P3
RIB demonstrated rapid absorption and a mean t1/2,acc of 32.0 h after oral administration of 600 mg QD in patients with cancer. Concomitant use of ET partners letrozole, anastrozole, and fulvestrant appears to have no clinically relevant PK interaction with RIB in patients with ABC.
- Checkmate 7A8: A phase 2 trial of nivolumab + abemaciclib or palbociclib + anastrozole in postmenopausal women with ER+, HER2- primary breast cancer (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1853;
For primary and secondary endpoints, estimates of response rates and corresponding 95% confidence intervals will be generated for each arm using the Clopper-Pearson method.No patients have yet been recruited. For information, please contact Xiaochun.Liu@bms.com.
- Verzenio (abemaciclib) / Eli Lilly, xentuzumab (BI-836845) / Boehringer Ingelheim, Eli Lilly
A phase Ib multi-cohort study of xentuzumab and abemaciclib in patients (pts) with solid tumors and breast cancer (BC) - initial report of four dose-finding cohorts (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1830;
P1
The safety profile of xentuzumab in combination with abemaciclib, with or without ET, was tolerable and manageable, with no new safety signals. Expansion cohorts for xentuzumab plus abemaciclib and fulvestrant in HR+ HER2- BC are ongoing.
- Arimidex (anastrozole) / AstraZeneca, Remedica
The effects of smoking and smoking cessation on postmenopausal breast cancer recurrence -Results from the Cohort 05 of the Rainbow of KIBOU (ROK) study: A prospective breast cancer survivor cohort in Japan (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1787;
The N-SAS BC 05 trial is the randomized multi-center open-label phase III trial to assess the effect of the extended use of anastrozole for an additional 5 years where postmenopausal patients with stage I-III, hormone-receptor-positive breast cancer, disease-free after 5 years of either anastrozole alone or tamoxifen 2-3 years followed by anastrozole 3-2 years were randomized to continual group with anastrozole for an additional 5 years or stop group without an additional anastrozole...The risk was decreased if they quit smoking even after diagnosis. Our study shows the importance of smoking cessation for breast cancer patients.
- Ibrance (palbociclib) / Pfizer
Quality of life in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer treated with palbociclib in real-world practice settings (Stars at Night Ballroom 3&4 - 3rd Level) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1717;
P=N/A
Changes from baseline in EORTC QLQ-C30 scores generally were below the 10-point threshold regarded as clinically meaningful. These early findings indicate that patients enrolled in the study have maintained their baseline QoL while being treated with palbociclib.
- Verzenio (abemaciclib) / Eli Lilly
Monarch E: A phase 3 study of standard adjuvant endocrine therapy with or without abemaciclib in patients with high risk, node positive, hormone-receptor positive, human epidermal growth factor receptor 2-negative early-stage breast cancer (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1676;
P3
J Clin Oncol. 2007;25(15):2127-32.
- letrozole / Generic mfg., Arimidex (anastrozole) / AstraZeneca, Remedica
Factors associated with aromatase inhibitor associated musculoskeletal symptoms in early stage breast cancer patients (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1405;
Of those, 23.4% changed or discontinued AI regimen due to severe AIMSS. Older age and higher circulating levels of vitamin D-25OH at the initiation of adjuvant AI therapy were associated with lower risk of developing severe AIMSS.
- saracatinib (AZD0530) / AstraZeneca
Aristacat - Aromatase inhibition plus minus saracatinib as advanced breast cancer therapy: A randomised phase II study of aromatase inhibition plus/minus the Src-inhibitor AZD0530 in post-menopausal women with advanced breast cancer (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1402;
Saractinib did not improve outcomes in post-menopausal women with advanced breast cancer treated with exemestane with numerically inferior p response rate and PFS, and no apparent beneficial effect on bone metastases. These data do not support further evaluation of saracatinib in combination with AIs.ARISTACAT - Abstract - San Antonio 2019
- Arimidex (anastrozole) / AstraZeneca, Remedica
Correlation between and molecular drivers of oncotype DX, prosigna, EndoPredict and breast cancer index: A TransATAC study (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1350;
Here we report from a unique database (i) the correlation between all 4 scores when measured by the respective manufacturers in the TransATAC set of samples and (ii) the degree to which each of the scores is driven by proliferation, oestrogen signalling, HER2 signalling and invasive properties insomuch as these are reflected by each component module of the RS test (PM, EM, HM and IM, respectively).MethodsThe TransATAC tumour sample set was collected from patients in the tamoxifen or anastrozole arms from the ATAC clinical trial of 5 years of endocrine therapy in postmenopausal patients with primary hormone receptor positive breast cancer...The EP, BCI and particularly ROR are dominated by proliferative features. These relationships provide and explanation for the differences that we and others have reported in the prognostic performance of the tests for both early and late recurrence.
- Ibrance (palbociclib) / Pfizer, Arimidex (anastrozole) / AstraZeneca, Remedica
Palbociclib in combination with anastrozole or exemestane as first-line therapy for patients with locally advanced, inoperable or metastatic HR+/HER2- breast cancer in Germany: Interim results of the INGE-B phase 2 study (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1290;
This interim analysis of the INGE-B study will provide so far lacking trial data on the treatment of palbociclib in combination with anastrozole or exemestane. The data will be discussed with respect to results of the PALOMA trials and already published interim analysis results of the INGE-B trial.
- Arimidex (anastrozole) / AstraZeneca, Remedica, Faslodex (fulvestrant) / AstraZeneca
Gene expression changes with neoadjuvant hormonal treatment (Hall 1 - Poster Session 5) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1259;
We also found multiple genes involving the PI3K-Akt and Notch pathway were differentially expressed in pre-treatment specimens among responders compared to non-responders. While the sample size comparing responders versus non-responders was inadequate, our results suggest some early trends which warrant further investigation.
- paclitaxel / Generic mfg.
An efficacy and safety trial of preoperative chemo-endocrine therapy in luminal b-like (HER2-negative) breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1171;
Endocrine therapy consisted of anastrozole for postmenopausal patients or anastrozole plus leuprorelin for premenopausal patients... The concomitant administration of endocrine therapy and chemotherapy in Luminal B-like breast cancer patients is similar to chemotherapy alone in pCR rate and clinical response in the preoperative setting.
- letrozole / Generic mfg., Arimidex (anastrozole) / AstraZeneca, Remedica, Faslodex (fulvestrant) / AstraZeneca
In-depth genomic analysis of acquired resistance to multiple sequential lines of endocrine therapy in breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1148;
Only KMT2C was identified as enriched in resistant tumours when comparing sensitive to only those that acquired resistance to 1st line LET. When comparing sensitive tumours to only those that had acquired resistance to multiple lines of ET (LET and TAM +/- AN and EX), sensitives were significantly enriched for mutations in CCDC141 and SLC9A9 and multi-drug resistant (MDR) tumours were significantly enriched for mutations in 11 genes including ESR1 and GATA3, and genes involved in cell adhesion (CDH1, FLG, FLG2 and FREM2).
- Zoladex (goserelin acetate implant) / AstraZeneca, TerSera Therap, Arimidex (anastrozole) / AstraZeneca, Remedica, Faslodex (fulvestrant) / AstraZeneca
Genome-wide association study predict prognosis of hormone receptor positive metastatic breast cancer in premenopausal women with endocrine therapy (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1034;
In terms of OS, 13SNPs were associated and eleven were in coding lesions (ZMYM4, GRM7, ERC2, LEKR1, C3orf700, CEP135, ZNF827, LOC285692, DNAH11, FLJ42102 and LOC283440).ConclusionsGenetic polymorphisms influenced the clinical outcome of HR+ MBC patients treated with anti-hormonal therapy. Further studies on the functional mechanisms relating to these SNPs in these genes are warranted.
- Adjuvant ovarian suppression plus aromatase inhibitor or tamoxifen for hormone receptor-positive breast cancer in women younger than 35 (ASPAIT): A multicenter randomized clinical trial (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1030;
P3
Patients who allergy to goserelin, leuprorelin, tamoxifen or AIs...Arm B: Exemestane 25mg, letrozole 2.5mg or anastrozole 1mg orally daily...Invasive Breast Cancer Recurrence-Free Interval. Adverse Effects Rate.
- Arimidex (anastrozole) / AstraZeneca, Remedica
Influence of aromatase inhibitor-related adverse events on the prognosis in postmenopausal Japanese patients with breast cancer: A prospective multicenter cohort study on patient-reported outcomes (Hall 1 - Poster Session 5) - Sep 25, 2019 - Abstract #SABCS2019SABCS_942;
The aim of this prospective cohort study based on patient-reported outcomes (PROs) was to examine the influence of adverse events on prognosis in Japanese postmenopausal patients with breast cancer treated with adjuvant anastrozole...By multivariable analysis including tumor size and grade, G2+3 joint symptoms were a significant and independent predictive factor for DFS (hazard ratio, 0.298, 95% confidence interval 0.122-0.621, p=0.0007). Conclusion Although adverse events might make patients uncomfortable and reduce their quality of life, it is suggested that worse or new vasomotor symptoms and severe joint symptoms, especially if they are grade 2 or 3, seem to associate with better prognosis.
- Afinitor (everolimus) / Novartis
Patterns of treatment with everolimus and exemestane in hormone receptor positive HER2 negative metastatic breast cancer in the era of targeted therapy (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_918;
Of these, 726 patients received EE in 1L (N=127), 2L (N=326), or 3L (N=273). In this cohort, 72.3% of patients were diagnosed between 2011-2014, and 27.7% were diagnosed after 1/2015, and most (94.6%) were treated in the community setting.
- Arimidex (anastrozole) / AstraZeneca, Remedica, Faslodex (fulvestrant) / AstraZeneca
Influence of the adjuvant hormonal therapy on hormone sensitivity and survival outcomes in ER+ and HER2?advanced breast cancer: A subgroup analysis of the JBCRG-C06 Safari study (Hall 1 - Poster Session 5) - Sep 25, 2019 - Abstract #SABCS2019SABCS_915;
Our results have consistency with the results of ABCSG-12 trial showing a pronounced higher risk of death for anastrozole-treated patients (Annals of Oncology 26: 313–320, 2015). Since it is a cohort of selected patients who were successfully treated with fulvestrant, prospective analysis would be therefore warranted.
- Kisqali (ribociclib) / Novartis
Real-world efficacy of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: second interim analysis from the RIBANNA study (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_861;
Based on the baseline demographics data, RIB (CDK4/6 inhibitor) treatment was found to be very well adopted among premenopausal and postmenopausal patients with HR+/HER2- aBC. The second interim analysis is planned for October 2019.
- Kisqali (ribociclib) / Novartis
Patient-reported outcomes, including work productivity, from the MONALEESA-7 trial of ribociclib plus endocrine therapy in patients with HR+/HER2- advanced breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_623;
P3
Analysis of PROs demonstrated that TTD ? 10% in global health status and emotional functioning were prolonged with RIB vs PBO.
- Verzenio (abemaciclib) / Eli Lilly
Updated subgroup tumor response of abemaciclib plus aromatase inhibitor for hormone receptor positive (HR+), HER2 negative advanced breast cancer (MONARCH 3) (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_620;
P3
NPJ Breast Cancer . 2018;4:41.Clinical trial information : NCT02246621This study was funded by Eli Lilly and CompanyTable: Objective Response Rate N= total number of patients in each subgroup; n= number of responder patients; NA=not applicable*Response rate not reported for bone-only disease because majority of lesions were not measurable
- Kisqali (ribociclib) / Novartis
A phase 2 randomized, double-blind, placebo-controlled study of ribociclib or placebo in combination with endocrine therapy for the treatment of premenopausal and postmenopausal Chinese women with HR+, HER2-, advanced breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_510;
Secondary endpoints are overall survival, overall response rate, clinical benefit rate, time to response, duration of response, and time to deterioration in ECOG PS. The objectives for the PK cohort are to characterize PK parameters of the RIB + LET combination, and of the RIB metabolites.
- Afinitor (everolimus) / Novartis
Neoadjuvant aromatase inhibitor therapy plus the mTOR inhibitor everolimus in postmenopausal women with hormone receptor positive/HER2 negative breast cancer and an oncotype Dx recurrence score (?25) (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_474;
The combination of an AI and everolimus was overall well tolerated. Our study suggested that baseline expression levels of key pathways were associated with response to neoadjuvant AI plus everolimus.
- Verzenio (abemaciclib) / Eli Lilly
Safety and efficacy of abemaciclib plus endocrine therapy (ET) in elderly patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced breast cancer: An age-specific subgroup analysis of MONARCH 2 and 3 trials (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_466;
P3
Abemaciclib in combination with ET demonstrates a tolerable safety profile and consistent efficacy benefit across all age subgroups examined, supporting the use of this combination in elderly patient populations. Despite the limited number of patients in the ?75 group with potentially confounding comorbidities, the safety data suggest that patient education and appropriate management of toxicities, including dose adjustments and use of supportive medication for gastrointestinal toxicities, could maximize the benefit of abemaciclib.
- letrozole / Generic mfg., Arimidex (anastrozole) / AstraZeneca, Remedica
Vaginal and sexual health of hormone-receptor positive breast cancer survivors on oral endocrine therapy: A cross-sectional study (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_427;
English-speaking women with HR+ breast cancer who had a treatment history with Tamoxifen or an AI (Anastrozole, Letrozole or Exemestane) for ? Our results support the notion that side effect management and patient-provider communication should be prioritized to optimize the vaginal and sexual health of women with HR+ breast cancer receiving oral ET.Women may be unaware of potential treatment options that can help manage side effects accompanying this therapy, and possibly accept these as a new standard of life.
- Arimidex (anastrozole) / AstraZeneca, Remedica
Tamoxifen versus anastrozole as adjuvant therapy in early stage breast cancer in premenopausal women on ovarian function suppression: A meta-analysis of randomized clinical trials (Hall 1 - Poster Session 5) - Sep 25, 2019 - Abstract #SABCS2019SABCS_423;
Among premenopausal women with early breast cancer, the use of AI plus OFS versus Tamoxifen plus OFS was not associated with significantly reduced event-free survival. Given the limited number of RCTs and low events, further, adequately powered trials are needed to validate this finding.
- Halaven (eribulin mesylate) / Eisai
A multicenter, randomized, phase II trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally-recurrent or metastatic breast cancer patients after progression on endocrine therapy (REVERT study) (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_394;
P2
ClinicalTrials.gov identifier: NCT03795012. First patient enrolled on June 24th , 2019.
- Arimidex (anastrozole) / AstraZeneca, Remedica
Ten year results of the international breast cancer intervention study II (Hall 3) - Sep 23, 2019 - Abstract #SABCS2019SABCS_231;
This updated analysis of the IBIS-II trial confirms the significant reduction in breast cancer occurrence with anastrozole in the post-treatment follow-up period. These results indicate a long-term preventive benefit with anastrozole for ER-positive breast cancer in postmenopausal women.Number of events and Hazard Ratios (95% CI) according to follow-up period.Number of eventsHR (95% CI)P-valueOverall241 (81 vs. 160)0.50 (0.38-0.65)<0.00010-5 years124 (35 vs.
- | amcenestrant (SAR439859) / Sanofi
Enrollment open, Monotherapy, Metastases: AMEERA-3: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (clinicaltrials.gov) - Sep 23, 2019
P2, N=282, Recruiting, Sponsor: Sanofi
These results indicate a long-term preventive benefit with anastrozole for ER-positive breast cancer in postmenopausal women.Number of events and Hazard Ratios (95% CI) according to follow-up period.Number of eventsHR (95% CI)P-valueOverall241 (81 vs. 160)0.50 (0.38-0.65)<0.00010-5 years124 (35 vs. Not yet recruiting --> Recruiting