 |
114 Diseases |  |
361 Trials |
|
361 Trials |  |
7200 News |  |
| «12...5556575859606162636465...100101» |
- || Piqray (alpelisib) / Novartis
Enrollment closed, Trial initiation date, Metastases: METALLICA: Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients (clinicaltrials.gov) - Oct 8, 2020
P2, N=68, Active, not recruiting, Sponsor: MedSIR
Not yet recruiting --> Active, not recruiting | Initiation date: Jun 2020 --> Oct 2020
- | Biomarker, Clinical Trial,Phase II, Journal: Predictive Role of TP53, PIK3CA and MLL2 in ER+ HER2+ Breast Bancer: Biomarker Analysis of Neo-ALL-IN [NCT 01275859]. (Pubmed Central) - Oct 8, 2020
Not yet recruiting --> Active, not recruiting | Initiation date: Jun 2020 --> Oct 2020 Mutations in TP53 and PIK3CA hotspot at exon 9 may be potential negative predictors of ER+HER2+ BC treated with neoadjuvant letrozole and lapatinib, while MLL2 inactivating mutation might confer therapeutic benefit in these patients.
- Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, Arimidex (anastrozole) / AstraZeneca, Remedica, Bonrise (ibandronate sodium) / Elder Pharma
[VIRTUAL] Description of Risk Factors at Baseline and Need of Bone Agent According to Hadji Recommendations in Patients Taking Aromatase Inhibitors as Breast Cancer Therapy () - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_693;
Highlight that only 30% of patients presented osteoporosis values in DXA at the initial assessment and that 21% had previous fractures, the most on the wrist. We consider the systematic assessment of the risk of fracture presented by patients with breast cancer who begin treatment with AI, assessing the need to prescribe bone agents using an algorithm as practical as that of Hadji.
- |||| amcenestrant (SAR439859) / Sanofi
Trial primary completion date, Metastases: AMEERA-5: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (clinicaltrials.gov) - Oct 7, 2020
P3, N=810, Not yet recruiting, Sponsor: Sanofi
We consider the systematic assessment of the risk of fracture presented by patients with breast cancer who begin treatment with AI, assessing the need to prescribe bone agents using an algorithm as practical as that of Hadji. Trial primary completion date: Sep 2026 --> Jan 2024
- |||||| giredestrant (GDC-9545) / Roche
Enrollment open: A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) (clinicaltrials.gov) - Oct 7, 2020
P3, N=978, Recruiting, Sponsor: Hoffmann-La Roche
Trial primary completion date: Sep 2026 --> Jan 2024 Not yet recruiting --> Recruiting
- | Piqray (alpelisib) / Novartis
Trial completion date: BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer (clinicaltrials.gov) - Oct 7, 2020
P1, N=46, Active, not recruiting, Sponsor: Vanderbilt-Ingram Cancer Center
Not yet recruiting --> Recruiting Trial completion date: Sep 2020 --> Sep 2021
- | letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome (clinicaltrials.gov) - Oct 5, 2020
P3, N=150, Recruiting, Sponsor: Assiut University
Trial completion date: Sep 2020 --> Sep 2021 Trial completion date: Aug 2020 --> Jun 2021 | Trial primary completion date: Jul 2020 --> Feb 2021
- | letrozole / Generic mfg.
New P2 trial: Letrozole in Patients With Hepatopulmonary Syndrome (clinicaltrials.gov) - Oct 5, 2020
P2, N=20, Not yet recruiting, Sponsor: Mayo Clinic
- || letrozole / Generic mfg.
What’s the status of the #dcis letrozole drug trial you were involved in? (Twitter) - Oct 5, 2020
- || letrozole / Generic mfg.
Clinical, Journal: Androgenicity and fertility treatment in women with unexplained infertility. (Pubmed Central) - Oct 4, 2020
Trial completion date: Aug 2020 --> Jun 2021 | Trial primary completion date: Jul 2020 --> Feb 2021 In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Treatment Outcomes and Healthcare Resources Utilization of Palbociclib in Advanced Breast Cancer () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1927;
CONCLUSIONS : This study supports the clinical benefit derived from palbociclib in addition to hormonotherapy, adding important insights regarding Patient-Reported Outcomes in a PCCC. Prolonged follow-up of these patients will result in more robust data and deeper understanding of drug effectiveness.
- [VIRTUAL] Cost-Utility of the CDK 4/6 Inhibitors for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer in Brazil- A Dime Project. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1895;
An indirect comparison was performed to identify the Hazard Ratio for CDK inhibitors versus letrozole...The most cost-effective technology was ribociclib ($64,425/QALY), followed by Abemaciclib ($81,530/QALY) and Palbociclib ($85,321/QALY)... In Brazil, even though there is no established willingness-to-pay threshold, the estimated ICER for the CDK 4/6 inhibitors will represent an obstacle to their incorporation into the Brazilian healthcare system.
- Ibrance (palbociclib) / Pfizer, letrozole / Generic mfg., Kisqali (ribociclib) / Novartis
[VIRTUAL] Sequencing IMPACT of (CDK4/ 6) Treatment Lines on Patient Outcomes for Metastatic Breast Cancer. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1445;
CONCLUSIONS The result of the study suggests that the impact of Palbociclib for enhancing patient outcomes is dominating. Using line of Palbociclib prior to (Ribociclib )for treatingmetastatic breast cancer may have dominant effect onpatient outcomes as a treatment strategy one of the challenges facing such kind of analysisis availability ofsurvival dataand importance ofselection of appropriatepatient criteria from different stake holders prospective .
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] An Incremental Effectiveness Analysis of Palbociclib for the Treatment of HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer in Portugal () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1061;
Using line of Palbociclib prior to (Ribociclib )for treatingmetastatic breast cancer may have dominant effect onpatient outcomes as a treatment strategy one of the challenges facing such kind of analysisis availability ofsurvival dataand importance ofselection of appropriatepatient criteria from different stake holders prospective . The treatment with palbociclib plus letrozole/fulvestrant showed a relevant incremental effectiveness both in terms of LY and QALY in the treatment of HR+/HER2- locally advanced or metastatic breast cancer in Portugal.
- || letrozole / Generic mfg., Avastin (bevacizumab) / Roche
Clinical, P2 data, Journal: TBCRC 002: a phase II, randomized, open-label trial of preoperative letrozole with or without bevacizumab in postmenopausal women with newly diagnosed stage 2/3 hormone receptor-positive and HER2-negative breast cancer. (Pubmed Central) - Oct 3, 2020
P2
There was additive toxicity with the incorporation of bevacizumab. Responses to Let/Bev can be predicted from the levels of 5 small RNAs in a pretreatment biopsy.
- ||| Ibrance (palbociclib) / Pfizer
P2 data, Retrospective data, Journal, Adverse events: Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. (Pubmed Central) - Oct 3, 2020
P2, P3
Responses to Let/Bev can be predicted from the levels of 5 small RNAs in a pretreatment biopsy. A decrease in frequency and severity of hematologic AEs, including febrile neutropenia, following palbociclib dose reduction was observed, supporting the recommended use of dose reduction in AE management.
- Z-endoxifen hydrochloride / Jina Pharma
[VIRTUAL] Antitumor activity of Z-endoxifen (ENDX) is mediated via PKCβ1-dependent ERα loss and cell cycle arrest in ERα-positive breast cancer (Channel 2) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1235;
While targeting PKCβ1 kinase activity elicited no anticancer effects in ERα+ cells, PKCβ1 downregulation, either by siRNA or ENDX, resulted in profound ERα turnover, reduced protein levels of essential cell cycle mediators and profoundly inhibited cell proliferation. Furthermore, PKCβ1 protein expression is associated with TAM, but not ENDX, resistance, a finding whose clinical relevance is further magnified by identification of PRKCB amplification in metastatic ERα+ BC, confirming its potential importance in progression.
- Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
[VIRTUAL] Final analysis of PERTAIN: A randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of first-line pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in patients with HER2-positive and hormone receptor-positive metastatic or locally advanced breast cancer (Channel 3) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1179;
P2
Induction IV chemotherapy with T q3w or weekly paclitaxel could be given for 18-24 weeks at the investigator’s discretion before the start of endocrine therapy...There were no new safety concerns at final analysis. Overall, PERTAIN provides additional evidence on the role of P + H in the first-line treatment of HER2-positive MBC/LABC and suggests that some pts benefit from P + H + AI without induction chemotherapy.
- letrozole / Generic mfg.
[VIRTUAL] Breast Cancer Index is a molecular signature of endocrine responsiveness that determines extended endocrine benefit independent of prognostic risk (Channel 2) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1176;
Both clinically High and Low risk patients derived a similar magnitude of benefit when stratified as BCI (H/I)-High (12.5% and 15.1%, respectively). Evaluation of BCI (H/I) predictive performance in the context of BCI prognostic risk categories showed similar results.
- Piqray (alpelisib) / Novartis
[VIRTUAL] Alpelisib + letrozole in patients with PIK3CA-mutated, hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + fulvestrant: BYLieve study results (Channel 2) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1172;
P2
Consistent with the known safety profile of alpelisib, manageable toxicities were observed. These data suggest that alpelisib in combination with LET may be an effective treatment option for pts with PIK3CA -mutated, HR+, HER2- ABC in the post-CDK4/6i setting.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib (Channel 2) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1169;
P3
With an extended follow-up of more than 4 years, RIB + ET continued to demonstrate a clinically relevant OS benefit compared with ET alone in pre- or perimenopausal patients with a median OS ~5 years with RIB +ET in HR+/HER2− ABC. A similar benefit with RIB was observed for PFS2, time to CT, and CT-free survival.
- Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
[VIRTUAL] Phase II randomized trial of neoadjuvant trastuzumab and pertuzumab with either palbociclib plus letrozole or paclitaxel for postmenopausal women with estrogen receptor-positive / HER2-positive breast cancer - The TOUCH trial () - Oct 2, 2020 - Abstract #SABCS2020SABCS_1139;
P2
The trial is conducted in collaboration with Unicancer GERICO and SAKK. NCT03644186
- Venclexta (venetoclax) / Roche, AbbVie, Ibrance (palbociclib) / Pfizer
[VIRTUAL] PALVEN: A phase 1b study of palbociclib, letrozole and venetoclax in estrogen receptor, BCL2-positive metastatic breast cancer () - Oct 2, 2020 - Abstract #SABCS2020SABCS_1137;
P1b
Accrual Target accrual is 6-36, depending on the number of dose cohorts required to reach DLT. Recruitment is active at 2 sites in Australia.
- SAR439859 / Sanofi
[VIRTUAL] AMEERA-4, a phase 2 window study of SAR439859 vs letrozole in post-menopausal women with newly diagnosed estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer () - Oct 2, 2020 - Abstract #SABCS2020SABCS_1106;
P1/2, P2
Reused with permission. This abstract was accepted and previously presented at the 2020 ASCO Annual Meeting.
- tamoxifen / Generic mfg.
[VIRTUAL] Winpro: A window of opportunity study of endocrine therapy with and without prometrium in postmenopausal women with early stage hormone receptor-positive breast cancer () - Oct 2, 2020 - Abstract #SABCS2020SABCS_1102;
Translational endpoints include definition of a predictive gene set biomarker for Ki67 reduction; tumor biomarkers after treatment, including apoptotic markers Bcl-2 and cleaved-caspase3, as well as protein and mRNA expression of ER, PR, AR, FoxA1, and CyclinD1; and levels of estrone, estradiol, E2, progesterone, testosterone, DHT, and DHEAS in serum and finger prick dried blood spot after treatment.Accrual: Enrolment commenced in February 2018 and 70 patients have been randomized from 7 sites to date (1 July 2020). Target accrual is 200 patients enrolled from 8 sites.Contact information: This study is led at The Kinghorn Cancer Centre, St Vincent’s Sydney Hospital Sydney, Australia, and funded by the Cancer Council of NSW and the NHMRC Translational Breast Cancer Project grant.
- fulvestrant / Generic mfg.
[VIRTUAL] Immune cell populations in peripheral blood of metastatic breast cancer patients under CDK4/6 inhibitors (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_977;
MethodsA prospective cohort of metastatic ER+/HER2- BC patients treated with CDK4/6i (palbociclib or ribociclib) was included...All patients received letrozole or fulvestrant, together with LHRH agonist if premenopausal...Additionally, a decrease in total T (-2.38%/month, p =0.002), Treg subtype II (-2.52%/month, p =0.0076), CD8CM T (-3.30%/month, p =0.006), CD4CM T (-3.97%/month, p =0.002), γδ1CM subset of γδ T (-2.73%/month, p =0.047), NK (-0.99%/month, p =0.011), and CD8Eff T (-1.72%/month, p <0.001) cells was observed in CDK4/6i NResp subgroup, with no significant changes in Resp subgroup. Conclusions Results suggest that significant immune profile changes occur in metastatic ER+/HER2- BC patients with early progression to CDK4/6i and endocrine therapy.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (ABC) and central nervous system metastases: Subgroup analysis of the phase IIIb CompLEEment-1 trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_863;
P3
Efficacy results support the use of RIB + LET in HR+, HER2- ABC in a close to real-world setting. The safety profile associated with RIB + LET was manageable, with few pts discontinuing treatment due to AEs, consistent with previous Phase III trials of RIB + LET.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Ribociclib + letrozole in male patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (ABC): Subgroup analysis of the phase IIIb CompLEEment-1 trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_859;
P3
In this subgroup analysis of male patients - a rare population who are often excluded from clinical trials - efficacy results support the use of RIB + LET in HR+, HER2- ABC in a close to real-world setting. The safety profile associated with RIB + LET was manageable, with very few patients discontinuing treatment due to AEs, consistent with previous Phase III trials of RIB + LET.
- Verzenio (abemaciclib) / Eli Lilly
[VIRTUAL] Management of abemaciclib associated diarrhea in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Analysis of the MONARCH plus study (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_829;
P3
Cohort A enrolled patients with initial treatment of endocrine therapy, received abemaciclib or placebo plus NSAI (anastrozole or letrozole); Cohort B enrolled patients who progressed on prior endocrine therapy, receiving abemaciclib or placebo plus fulvestrant. Majority of diarrhea events were of low grade in severity and well managed by anti-diarrheal medications, dose omissions or/and dose reductions in MONARCH plus patients.
- tamoxifen / Generic mfg.
[VIRTUAL] Fertility preservation for breast cancer patients before chemotherapy (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_807;
Wider implications: We systematically investigated various aspects of ovarian stimulation for oocyte retrieval in breast cancer patients undergoing fertility preservation prior to chemotherapy, our review indicated that (1) random-start controlled ovarian stimulation protocol showed comparable oocyte yields with minimal delays of referral to initiate ovarian stimulation; (2) two ovarian stimulation cycles results in higher numbers of retrieved oocytes while back-to-back and conventional two cycles showed no significant differences; (3) combinations with letrozole demonstrated a safer way over tamoxifen and anastrozole in terms of lowering estradiol level during stimulation processes; (4) in vitro maturation of immature oocytes can maximize the numbers of oocytes for cryopreservation; and (5) regarding patients’ genetic backgrounds, those with BRCA mutations have lower AMH levels, but similar in numbers of retrieved oocytes to those without BRCA mutations. Nonetheless, we look forward to higher evidence-level studies to understand the clinical relevance of these protocols for ovarian stimulation in breast cancer patients desiring fertility preservation before chemotherapy.
- tamoxifen / Generic mfg., everolimus / Generic mfg., fulvestrant / Generic mfg.
[VIRTUAL] From clinical trials to clinical practice: Real-life outcome data of everolimus and exemestane in the treatment of patients with metastatic breast cancer (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_801;
Fulvestrant was given as a third line endocrine therapy in 54 (59.3%) patients...Conclusions : Despite enrolling sicker and heavier-pretreated patients, our real-life outcome data for both efficacy and safety of exemestane and everolimus matches those reported in major clinical trials. Such results should assure clinicians and should lead to wider utilization of this oral, chemotherapy-sparing regimen.
- Opdivo (nivolumab) / Ono Pharma, BMS, Verzenio (abemaciclib) / Eli Lilly
[VIRTUAL] Phase II study of nivolumab in combination with abemaciclib plus endocrine therapy in patients with HR+, HER2- metastatic breast cancer: WJOG11418B NEWFLAME trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_787;
P2
Toxicity profiles vary with CDK4/6 inhibitors; therefore, a different inhibitor may improve tolerability. Results of the ongoing nivolumab, palbociclib, and ET trial are awaited (CheckMate 7A8, NCT04075604).
- Herceptin (trastuzumab) / Roche, Tecentriq (atezolizumab) / Roche, Reolysin (pelareorep) / Oncolytics, Andrus Reo
[VIRTUAL] A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1) (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_785;
P1
Background: A previous phase 2 study in metastatic breast cancer compared treatment with intravenously delivered oncolytic reovirus, pelareorep (pela), in combination with paclitaxel (PTX) versus PTX alone...Cohort 4: Hormone Receptor-positive/HER2-positive (HR+/HER2+) (6 patients), pelareorep + trastuzumab + atezolizumab...Results : Detailed translational research results will be presented from patients in cohort 1, who received just pelareorep and letrozole...Overall, preliminary data from cohort 1 of AWARE-1 demonstrate pela-mediated priming of an adaptive immune response. (NCT04102618)
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Letrozole and palbociclib versus 3rd generation chemotherapy as neoadjuvant treatment in luminal breast cancer: Survival results of the UNICANCER-NeoPAL study (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_780;
P2
PEPI (PEPI II/II vs I: HR 0.80, 95%CI 0.18-3.67) and RCB scores (RCB II/III vs 0/I: HR 1.36; 95%CI 0.17-10.6) did not appear as independent predictors of PFS or iDFS. Conclusions Despite its small size, NeoPAL suggests that a neoadjuvant LETPAL strategy, together with selected postoperative administration of chemotherapy, may spare chemotherapy in some pts with luminal breast cancer while allowing very good long-term outcomes.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Safety and efficacy of an alternative schedule of palbociclib (PAL) in hormone receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer (MBC) and the utility of serum thymidine kinase 1 (sTK1) activity in predicting PAL response (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_779;
P2
The efficacy data is comparable to prior reports. sTK1 shows promise for PAL response prediction and monitoring.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Targeted safety events from a phase I/Ib study evaluating GDC-0077 alone and in combination with endocrine therapy (ET) ± palbociclib (palbo) in patients (pts) with PIK3CA-mutant (mut), hormone receptor-positive/HER2-negative metastatic breast cancer (HR+/HER2- mBC) (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_751;
P1, P3
No unexpected safety events were reported in combination with palbo. A phase III study of GDC-0077 in combination with palbo and fulvestrant is enrolling currently (NCT04191499).
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Phase 3b CompLEEment-1 study of ribociclib plus letrozole in the treatment of HR+/HER2- advanced breast cancer: Final results from the UK cohort (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_731;
P3
This treatment combination showed consistent efficacy and side effect profile in UK HR+, HER2- ABC patients, consistent with the overall ITT population as well as results observed in the other pivotal ribociclib registration studies. NCT02941926.
- cyclophosphamide intravenous / Generic mfg.
[VIRTUAL] Treatment patterns and clinical outcomes among patients (pts) with HER2- advanced breast cancer (ABC) and somatic BRCA1/2 mutation(s) (sBRCA1/2mut): Results from a US real-world study (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_718;
Poor clinical outcomes highlight the need for more efficacioustreatment options. Further studies assessingclinical outcomes among patients with sBRCA1/2 mut ABC receivingPARPi are warranted.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Ribecca - a phase 3b, multi-center, open label study for women with estrogen receptor positive, locally advanced or metastatic breast cancer treated with ribociclib (lee011) in combination with letrozole: Final results (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_713;
The results of the final analysis confirmed clinical benefit of ribociclib and letrozole in this patient population. No new safety signals emerged.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] A phase II proof-of-concept study of palbociclib (P) rechallenge in patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC) and clinical benefit to prior P-based treatment (BIOPER) (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_709;
P2
This strategy is currently being evaluated in the randomized phase II PALMIRA trial. Further research is ongoing to identify patient subgroups who could benefit from this treatment strategy.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Palbociclib (P) in combination with fulvestrant (F) or letrozole (L) in endocrine-sensitive patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC): detailed safety analysis from a multicenter, randomized, open-label, phase II trial (PARSIFAL) (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_699;
Although rare, ILD/pneumonitis can be a side effect of P-based regimens. VTE and PE incidence rates were low and consistent with age-specific analyses from PALOMA trials and breast cancer population.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: Third interim analysis from the RIBANNA study (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_698;
The third interim analysis is planned in October 2020, and the updated baseline data, information on safety, digital ECG measurement using CANKADO application will be presented. $$MISSING OR BAD TABLE SPECIFICATION {6A08F088-108A-4CF1-82CE-E9E331DB5576}$$
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Efficacy and safety of palbociclib (PAL) in patients (pts) with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with preexisting conditions: A post hoc analysis of PALOMA-2 (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_696;
P3
PAL + LET showed prolonged PFS and a consistent safety profile regardless of baseline preexisting condition in pts with ER+/HER2– ABC. Clinical trial identification: Pfizer Inc (NCT01740427) Table
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Ribociclib + letrozole in premenopausal patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC): Subgroup analysis of the phase IIIb CompLEEment-1 trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_692;
P3
ORR was similar to that seen in the Phase III MONALEESA-7 trial which studied RIB + ET in a premenopausal patient population, validating the efficacy of RIB in a close-to-real-world setting. The safety profile associated with RIB + LET was manageable and consistent with previous Phase III trials of RIB + LET.
- Kisqali (ribociclib) / Novartis
[VIRTUAL] Ribociclib + letrozole in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2−) advanced breast cancer (ABC): Expanded safety analysis of the phase IIIb CompLEEment-1 trial (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_687;
P3
AEs associated with RIB + LET combination therapy were manageable, consistent with previous Phase III trials of RIB + LET - and adjusted IRs for AESI notably decreased from Year 1 to Year 2 of treatment. These data further support the use of RIB + LET for first-line treatment of HR+, HER2- ABC in both men and women of any menopausal status and in a broader and more diverse patient population.
- Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Seagen
[VIRTUAL] Interim safety and efficacy analysis of phase IB / II clinical trial of tucatinib, palbociclib and letrozole in patients with hormone receptor and HER2-positive metastatic breast cancer (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_685;
P1/2
All pts had prior therapy with trastuzumab and pertuzumab and 18 pt (45%) had prior T-DM1. The combination of tucatinib with letrozole and palbociclib showed a tolerable and manageable safety profile and evidence of considerable anti-tumor activity that warrant further clinical investigation in pts with HR+/HER2+ MBC.
- Arimidex (anastrozole) / AstraZeneca, Remedica
[VIRTUAL] The efficacy of a comprehensive bone health program in maintaining bone mineral density in postmenopausal women with early-stage breast cancer treated with endocrine therapy (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_643;
Such risk increases significantly with the use of AI. However, early interventions with modifiable risk factors, Vitamin-D supplements and use of bone-modifying agents can lower this risk.
- letrozole / Generic mfg.
[VIRTUAL] Inhibition of estrogen biosynthesis by hops, licorice species, and their bioactive compounds (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_582;
The extracts suppress NF-kB transactivation in MCF-7 cells, suggesting inhibition of inflammatory response. Further studies will better elucidate the potential of these popular botanicals and their bioactive compounds for preventing breast cancer in menopausal women.
- tamoxifen / Generic mfg.
[VIRTUAL] Dietary supplement use in a healthy eating and exercise lifestyle intervention in breast cancer survivors: The Lifestyle Exercise and Nutrition (LEAN) Study (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_581;
Our findings are indicative of the high prevalence of DS use among breast cancer survivors and the potential risk of interactions with prescribed hormonal therapy. More research is needed to test if counseling from a RD, CSO can reduce DS use and ultimately lead to better outcomes due to fewer interactions with breast cancer treatments.
- Ibrance (palbociclib) / Pfizer
[VIRTUAL] Pre/perimenopausal (preMeno) women receiving palbociclib (PAL) for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2‒) advanced breast cancer (ABC) in a real-world setting: Treatment patterns from POLARIS (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_504;
P=N/A
The majority of preMeno pts in this real-world dataset received PAL+LET as 1L ABC treatment; PAL was primarily initiated at the recommended dose (125 mg) and was well tolerated with few dose modifications required. Clinical trial identification: Pfizer (NCT03280303)