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114 Diseases |  |
361 Trials |
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361 Trials |  |
7200 News |  |
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- | maveropepimut-S (MVP-S) / BioVaxys
Enrollment open, Trial initiation date: Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer (clinicaltrials.gov) - Oct 27, 2021
P1, N=18, Recruiting, Sponsor: Providence Health & Services
Not yet recruiting --> Recruiting | Initiation date: Jun 2021 --> Sep 2021
- | Kisqali (ribociclib) / Novartis
Trial completion: Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer (clinicaltrials.gov) - Oct 26, 2021
P2, N=40, Completed, Sponsor: Mayo Clinic
Not yet recruiting --> Recruiting | Initiation date: Jun 2021 --> Sep 2021 Active, not recruiting --> Completed
- || limantrafin (CB-103) / Cellestia Biotech
Enrollment closed: CAILA: CB-103 Plus NSAI In Luminal Advanced Breast Cancer (clinicaltrials.gov) - Oct 26, 2021
P2, N=80, Active, not recruiting, Sponsor: MedSIR
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- tamoxifen / Generic mfg.
Assessment of estrogen receptor (ESR1) mRNA expression for prediction of extended aromatase inhibitor benefit in HR-positive breast cancer using NRG Oncology/NSABP B-42 (Hall 4A) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1542;
Confidence intervals were relatively wide but rule out a strong predictive effect of the ER single gene score in the expected direction. Support: U10CA180868, -180822, U24CA196067; Novartis; Exact Sciences
- letrozole / Generic mfg.
Breast Cancer Index and assessment of the Net Treatment Benefit (NTB) of extended endocrine therapy in HR+ breast cancer (Hall 4A) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1541;
It should be noted that the results of our analysis could be biased due to a shorter AE recording period in the 2.5y arm, hence the true benefit/risk of EET could be larger than reported here. Quantification of a net treatment benefit when considering the impact of both efficacy and toxicity may represent a new paradigm for evaluation of the overall EET benefit and aid in patient selection for EET.
- Ibrance (palbociclib) / Pfizer
Overlapping molecular features (proliferation, immune signatures and TP53 mutations) associated with palbociclib resistance inER+HER2- primary breast cancer (Hall 4A) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1540;
We show that there is an overlap between resistance mechanisms and TP53 mutations. However, ER+HER2- patients with TP53 mutations may still benefit from PALBO adding to suppression of proliferation compared to LET-only treatment.
- letrozole / Generic mfg.
Primary analysis from NEOS trial: A randomized phase III study that assessed the long-term prognosis of estrogen receptor positive (ER+) primary breast cancer (PBC) pts who received neoadjuvant endocrine therapy (NET) with/without adjuvant chemotherapy (CT) (Stars at Night 1/2) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1527;
Pts were treated by letrozole (LET) in weeks 24-28 after primary enrollment...Adjuvant chemotherapy should be selected by any clinical factors and genomic tool regardless of response by NET for ER+ PBC. UMIN000001090
- Piqray (alpelisib) / Novartis
Alpelisib + fulvestrant in patients with PIK3CA -mutated, HR+, HER2— advanced breast cancer (ABC) who received chemotherapy or endocrine therapy (ET) as immediate prior treatment: BYLieve Cohort C primary results and exploratory biomarker analyses (Stars at Night 1/2) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1523;
P2
In Cohort A of BYLieve, efficacy of ALP + FUL suggests clinical benefit immediately after CDKi + AI; Cohort C confirms clinically relevant activity of ALP + FUL in a heterogeneous population, primarily treated in the third line or later, and potentially regardless of ESR1 status or ctDNA fraction, with no new safety signals detected. Together, these data confirm that ALP targets the effects of the PIK3CA -driver oncogene in HR+, HER2- ABC.
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Phase Ib expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ metastatic breast cancer (Stars at Night 1/2) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1520;
Responses were also observed in patients refractory to the last treatment. Therapy was well tolerated with manageable toxicity and low number of treatment discontinuation due to related AE.
- fulvestrant / Generic mfg.
A platform of CDK4/6 inhibitor-resistant patient-derived breast cancer organoids illuminates mechanisms of resistance and therapeutic vulnerabilities (Hall 4A) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1481;
PDOs can be successfully established from ER+ MBC biopsies, maintain the resistant phenotype in culture, retain driver alterations found in tumors from which they were derived, and fail to suppress E2F targets following treatment with CDK4/6i. Therefore, these PDOs represent valuable models to understand and explore diverse mechanisms of CDK4/6i resistance and therapeutic vulnerabilities.
- tamoxifen / Generic mfg.
Cardioprotective effects of walnuts against aromatase inhibitor: Pilot study in a zebrafish model (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1462;
The protective effect may be mediated by prevention of letrozole-induced inhibition of GPER which acts as a vasodilator in the vasculature and cardiomyocytes. Future studies are planned to investigate if feeding adult zebrafish walnut powder and/or walnut oil has cardioprotective effects against chronic letrozole administration, whether GPER is the mediator of these effects, and if GPER acts through activating pathways such as EGFR, ERK, PI3K/Akt and cAMP/PKA.
- fulvestrant / Generic mfg.
Developing IpY: A novel inhibitor for the treatment of ER+ CDK4i-resistant breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1437;
As the majority of the drug resistance seen withCDK4 inhibitory drugs is a result of compensatory CDK2 activity, IpY.20 preventsacquired drug resistance by hitting both CDK4 and CDK2 simultaneously, resulting in amore durable response to the drug. Concarlo is currently in manufacturing with IpY.20.
- Ibrance (palbociclib) / Pfizer
Neoadjuvant letrozole plus palbociclib in patients (pts) with hormone receptor (HR)-positive/HER2-negative early breast cancer (EBC) with baseline Ki67 ≥20% and an Oncotype DX Breast Recurrence Score ® result (RS) ≥18: DxCARTES (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1432;
Although the prognostic value of molecular downstaging is unknown, a significant proportion of HR-positive/HER2-negative EBC pts with high RS at baseline achieve a pathological or molecular downstaging with this regimen. Further investigation is needed to determine if this strategy could avoid the use of chemotherapy in this population.
- ebvaciclib (PF-06873600) / Pfizer
A first-in-human phase 1/2a dose escalation/expansion study of the first-in-class CDK2/4/6 inhibitor PF‑06873600 alone or with endocrine therapy in patients with breast or ovarian cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1426;
P2
PF-3600 can be combined with ET with a manageable AE profile and demonstrates promising preliminary antitumor activity in heavily pretreated pts, including those with HR+/HER2– BC progressing on ET + CDK4/6i and Cx. Dose expansion in combination with ET in pts with HR+/HER2– BC with and without prior CDK4/6i Tx is ongoing.
- Ibrance (palbociclib) / Pfizer
Effectiveness of palbociclib plus letrozole vs letrozole in US Hispanic and African American patients with metastatic breast cancer: Flatiron database analysis (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1398;
Further research with more patients and longer follow-ups is warranted in minority MBC patients. PB+LE= Palbociclib plus letrozole; LE= Letrozole alone; IQR= Interquartile range; NR= Not reached; OS= Overal surval; rwPFS = real-world progression free survival
- fulvestrant / Generic mfg.
Efficacy of first line CDK4/6 inhibitors in HER2-low vs HER2-zero, hormone receptor positive, HER2 negative metastatic breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1378;
Our results suggest a lower benefit of CDK4/6 inhibitors in the first line treatment of HER2-low MBC, which could be partially explained by a relative higher proportion of non-luminal PAM-50 subtypes in HER2-low tumors. Funding This project has received a research grant from “Instituto de Salud Carlos III (ISCIII), Ministerio de Economía y Competitividad” (Spain) awarded within the National Research Program with reference PI 18/01408, co-funded with European Union ERDF funds (European Regional Development Fund).
- Ibrance (palbociclib) / Pfizer
Serum thymidine kinase 1 activity (TKa) levels and progression-free survival (PFS) in patients (pts) with hormone receptor positive (HR+) HER2-negative metastatic breast cancer (MBC) on palbociclib (Pb) and endocrine therapy (ET) (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1376;
While the end of C2 TKa levels were not associated with PFS, the interpretability of these data are limited, given treatment delays (0-36 days) prior to starting C3 that may result in TKa rebound. Future studies evaluating the predictive nature of TKa and Pb response should focus on earlier timepoints while on drug.
- Verzenio (abemaciclib) / Eli Lilly
Implications of body mass index (BMI) on the biological and clinical effects of endocrine therapy and abemaciclib in the neoadjuvant setting (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1361;
Moreover, BMI did not have an impact on radiological and clinical response rates after 14 weeks of treatment with letrozole and abemaciclib. Although limited by the small sample size, these results are reassuring that the combination of letrozole and abemaciclib appears to be active in the early setting regardless of baseline BMI.
- Piqray (alpelisib) / Novartis
Alpelisib + endocrine therapy (ET) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA -mutated advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i): Biomarker analyses from the Phase II BYLieve study (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1357;
P2
In pts with HR+, HER2-, PIK3CA -mutated ABC, ALP was effective in the post-CDK4/6i setting regardless of ET partner and tumor genomic profile (including in presence of alterations in genes associated with CDK4/6i resistance). The absence of cross-resistance may allow pts with PIK3CA -mutated disease to benefit from ALP after disease progression on/after CDK4/6i.
- Ibrance (palbociclib) / Pfizer
Patient-derived xenografts (PDXs) generated from hormone receptor-positive breast cancer (BC) before and after cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) treatment: Initial findings from the PROMISE study (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1261;
P=N/A
Fresh tumor samples obtained pre-treatment from 43 eligible pts (32 FL), after C2 from 17 eligible pts (13 FL), and at disease progression from 10 eligible pts (5 FL) were implanted. Tumor growth was seen in at least one mouse from a pre-treatment specimen in 1 (3.1%) FL pt (confirmed BC) and 4 (36.4%) SL pts (2 confirmed BC); from end of C2 specimens in 2 (15.4%) FL pts and 2 (50%) SL pts (1 confirmed BC); and at progression in 1 (20%) FL pt and 2 (40%) SL pts (1 confirmed BC).
- fulvestrant / Generic mfg.
Establishment and characterization of luminal A breast XPDX models from patients with acquired resistance to CDK 4/6 inhibitors (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1260;
Conclusion : We have established and characterized a panel of nine XPDX models from eight female patients with luminal A breast cancer at time of progression following acquired resistance to CDK4/6 inhibitor therapy, seven of which were found resistant to single agent palbociclib and abemaciclib and all nine to fulvestrant. This panel can be utilized as a valuable tool in better understanding CDK4/6 inhibitor resistance and in developing novel therapies for CDK4/6 inhibitor-resistant patients.
- Kisqali (ribociclib) / Novartis
Health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative, luminal B breast cancer patients treated with ribociclib plus letrozole or chemotherapy (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1188;
P2
R+L provided better outcomes in GHS HRQoL, functioning and symptoms in comparison with CT for the treatment of patient with high-risk breast cancer in the pre-operative setting. Together with the similar clinical efficacy and manageable safety profile, these results provide additional support for the development of clinical trials evaluating R+L in this patient population.
- Ibrance (palbociclib) / Pfizer
Incidence of patient-reported fatigue developing in patients receiving palbociclib and endocrine therapy for advanced HR+ HER2- breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1176;
While direct comparison cannot be made between provider-rated CTCAE and patient-reported PRO-CTCAE, it is notable that the incidence of severe fatigue with PRO-CTCAE is higher than that observed with provider-rated CTCAE. Ongoing analyses will explore potential associations of factors (e.g., hematological, sleep, activity) with treatment-emergent fatigue developing on palbo and ET therapy.
- Kisqali (ribociclib) / Novartis
Thromboembolic events (TEE) in patients with HER2-negative, hormone receptor-positive metastatic breast cancer treated with Ribociclib combined with Letrozole or Fulvestrant. Real-world data (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1104;
In real-world settings, and contrary to recent reports, breast cancer patients treated with ribociclib with AI or fulvestrant are not at higher risk for arterial or venous thromboembolic events. Patients had similar rates prior to initiation, and after stopping ribociclib.
- Fablyn (lasofoxifene) / Pfizer, Ligand, Sermonix
Lasofoxifene as a potential treatment for aromatase inhibitor resistant ER positive breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1096;
In addition, all treatments, except fulvestrant, inhibited bone metastasis versus vehicle. These data show that lasofoxifene is more effective than fulvestrant in this tumor model and suggest that lasofoxifene has potential as an effective therapy for AI resistant breast cancers that do not express ERα activating mutations.
- letrozole / Generic mfg.
The association between adiposity and anti-proliferative response to neoadjuvant endocrine therapy with letrozole in post-menopausal patients with estrogen receptor positive breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1091;
This study suggests that anti-proliferative response to neoadjuvant aromatase inhibition might be more frequent in patients with increased adiposity as compared to lean patients. These observations, which need to be confirmed in larger series of patients, highlight the need of investigating treatment efficacy and BC biology according to the adiposity of the patient.
- fulvestrant / Generic mfg.
Multiomics data reveal novel biomarkers for CDK4/6 resistance (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1076;
Distinct multi-omic changes identified in serum samples obtained from PROMISE participants M1 and M2 on Pb correlate with disease progression in both 1L and 2L settings. Additionally, validation studies will determine the significance of these findings.
- tamoxifen / Generic mfg.
Impact of endocrine therapy (ET) noncompliance following intra-operative radiation therapy (IORT) in treatment of early-stage breast cancer patients (pts) enrolled in the ExBRT trial (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1036;
Early-stage ER+ breast cancer pts compliant with a subsequent course of ET in this study experienced a lower IBTR rate, improving the collective outcome of their multidisciplinary treatment. These preliminary ExBRT trial results demonstrate that IBTR rates are improved with ET compliance.
- tamoxifen / Generic mfg.
A 10 year retrospective study of male breast cancer patients within central Scotland (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_960;
A delay in diagnosis also means that many patients present at a higher stage of the disease, with more nodal involvement. Tamoxifen is the hormonal therapy of choice in these patients.
- tamoxifen / Generic mfg.
Single nucletotide polymorphisms of aromatase gene (CYP19A1) and toxicity of adjuvant aromatase inhibitors: A translational, prospective study (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_907;
The GIM4 trial randomized HR+ BC postmenopausal patients who had been already treated with 2-3 years of adjuvant tamoxifen to either 3-2 years or 5 years of adjuvant letrozole. SNPs of CYP19A1 could be useful biomarkers of long-term toxicity in HR+ BC patients who are candidates for adjuvant AI.
- letrozole / Generic mfg.
Background parenchymal enhancement as an imaging biomarker in neoadjuvant endocrine therapy for DCIS (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_869;
Patients took letrozole 2.5 mg/day for 6 months before surgery (BCS, 53; mastectomy, 6)...J Clin Oncol. 38(12) 1284-92, 2020
- Irene (pyrotinib) / Jiangsu Hengrui Medicine
Pyrotinib in combination with letrozole for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer: A multicenter, single-arm, phase II trial (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_798;
P2
Pyrotinib combined with letrozole showed an encouraging antitumor activity with good tolerance in patients with ER/HER2 co-positive MBC, promising as an alternative treatment option for this disease. The study is ongoing.
- Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche
Phase 2 study of neoadjuvant palbociclib, letrozole, and trastuzumab in patients with ER+ HER2+ breast cancer (PALTAN) (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_768;
P2
RNA sequencing and Ki67 data indicated potent anti-proliferative effects of study treatments, despite significant heterogeneity of intrinsic subtypes. Clinical trial information: NCT02907918.
- letrozole / Generic mfg.
Efficacy, safety and survival of neoadjuvant chemotherapy with different estrogen deprivation stratified by menstrual status versus chemotherapy alone in locally advanced breast cancer (SHPD002)—— A randomized multicentre, open-label, phase 3 Triab (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_747;
P2/3
The adoption of the CPS+EG score may be a better surrogate endpoint for survival outcomes. The addition of letrozole to neoadjuvant chemotherapy confers no therapeutic advantage in terms of tumor response or survival outcome.
- goserelin acetate / Generic mfg., letrozole / Generic mfg.
Randomized trial of neoadjuvant chemotherapy with or without concurrent aromatase inhibitor therapy to downstage ER+ve breast cancer: Breast Cancer Trials group ANZ 1401 ELIMINATE trial (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_746;
The ANZ 1401 ELIMINATE trial demonstrated a non-significant improvement in down-staging to pathologic stage 0 or 1A in luminal breast cancer with concurrent neoadjuvant chemotherapy and aromatase inhibitor therapy. An additional 9% patients receiving CET achieving a RCB score < 2 but BCS rates were similar in both groups.
- Ibrance (palbociclib) / Pfizer
Blood tumor mutational burden (bTMB) and blood copy number burden (bCNB) by genome-wide circulating tumor DNA (ctDNA) assessment predict outcome and resistance in hormone-receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer (MBC) patients (pts) treated with CDK4/6 inhibitor (CDK4/6 i ) (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_660;
P2
Our study also discovered novel candidate genes involved in cell cycle and DNA damage repair pathways in association with poor outcome. Results from this study highlight the genomic heterogeneity of HR+, HER2- MBC and provide important insights in the understanding of CDK4/6 i and ET resistance mechanisms to guide therapeutic development in pts with resistant disease.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Esr1 hotspot mutations in circulating tumor DNA mutation are associated with endocrine therapy resistance in metastatic breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_627;
The outcome of this study demonstrated that patients with mutations on known ESR1 hotspots (E380Q, L536H, Y537N/C/S and D538G) develop clinical resistance to endocrine therapy. Evaluation of these ESR1 hotspots mutations by ctDNA could be reliably used to monitor the response to endocrine therapy and predict the prognosis for MBC patients.
- Ibrance (palbociclib) / Pfizer, Herceptin (trastuzumab) / Roche
Palbociclib and trastuzumab for HER2-positive metastatic breast cancer (SOLTI-1303 PATRICIA): Final results from cohort A and B, prospective, open-label, multicenter phase II study (Stars at Night 3/4) - Oct 26, 2021 - Abstract #SABCS2021SABCS_592;
P2
Median follow-up was 42.3 months (IQR 34.7-54.8). The PFS6 rate in cohorts A, B1, and B2 was 33.3% (5/15), 42.8% (12/28), and 46.4% (13/28), respectively.
- Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Real-world outcomes with palbociclib, abemaciclib and ribociclib; experience of a tertiary oncology centre in the United Kingdom (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_588;
Predictors of good outcome include subsequent everolimus, strong PR+, strong ER+ and ILC. The prognostic benefit of lobular histology has not been definitively shown elsewhere.
- Ibrance (palbociclib) / Pfizer, Tukysa (tucatinib) / Seagen
Intracranial efficacy of tucatinib, palbociclib and letrozole combination in patients with HR+/HER2+ breast cancer and brain metastases (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_583;
P1/2
Because the majority of patients had treated (non-target) CNS lesions, evaluation of CNS response was limited and biased towards SD. However, the prolonged CNS-PFS in this small patient subset suggests anti-tumor activity of this non-chemotherapy based targeted regimen in the CNS.
- Verzenio (abemaciclib) / Eli Lilly
Abemaciclib plus fulvestrant or nonsteroidal aromatase inhibitor in participants with HR+, HER2- breast cancer - A pooled analysis of the endocrine therapy-naïve participants with measurable disease in MONARCH 2 and MONARCH 3 (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_579;
P3
Primary analysis of confirmed ORR in M2 and M3 EN participants with measurable disease compares favorably with previously reported ORR for fulvestrant monotherapy (FALCON study: 46% unconfirmed; FIRST study: 36% unconfirmed) or NSAI (PALOMA-2 study: 44.8% confirmed; MONALEESA-2: 34% unconfirmed) in participants with a similar disease state. The safety profile is similar to that reported in the primary M2 and M3 main studies.
- Ibrance (palbociclib) / Pfizer
Real-world effectiveness of palbociclib plus letrozole vs letrozole alone for metastatic breast cancer with lung/liver metastases: Flatiron database analysis (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_578;
Further comparative effectiveness research of CDK4/6i combination vs endocrine therapy with more patients and longer follow-up is warranted in MBC patients with various visceral metastases. Table.
- Kisqali (ribociclib) / Novartis
Real-world efficacy of ribociclib + aromatase inhibitor/fulvestrant, or endocrine monotherapy, or chemotherapy as first-line treatment in women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) locally advanced or metastatic breast cancer: Fourth interim analysis from the RIBANNA study (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_574;
The data from fourth interim analysis, which is planned in October 2021, including final baseline demographic data and updated safety data will be presented. Table 1.
- Ibrance (palbociclib) / Pfizer
Efficacy and safety of palbociclib plus endocrine therapy in Black and Hispanic patients with hormone receptor positive/human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- ABC) participating in the PALOMA trials (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_572;
P2, P3
These findings support the continued use of PAL + ET as a standard of care in these patients. Considering the substantial burden of breast cancer in Black and Hispanic patients, their relatively small representation in the PALOMA trial program highlights the need to increase diversity in clinical trials.
- Piqray (alpelisib) / Novartis
Effect of duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy (≤6 mo or >6 mo) on alpelisib benefit in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA -mutated advanced breast cancer (ABC) from BYLieve (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_567;
Conclusions : This demonstrates that pts with PIK3CA -mut, HR+, HER2- ABC who achieved ≤6-mo duration of disease control with prior CDK4/6i had a numerically longer PFS in Cohort A, and almost the same clinical efficacy in Cohort B, to ALP + ET vs pts with >6-mo duration of disease control, with a comparable safety profile. This confirms targeting PI3Kɑ with ALP provides clinical benefit in pts with CDK4/6i-resistant ABC, including early progressors, and supports consideration of ALP + ET as an immediate next-line option in this setting, possibly delaying chemotherapy.
- Piqray (alpelisib) / Novartis
Alpelisib + fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA -mutated advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + aromatase inhibitor (AI): 18-month follow-up of BYLieve Cohort A (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_562;
P2
These data will provide insights on the long-term efficacy and safety of ALP + FUL. This combination is currently approved and used, in the clinical setting, for the treatment of pts with HR+, HER2- PIK3CA -mutated ABC.
- Ibrance (palbociclib) / Pfizer
Efficacy of limited dose modifications for palbociclib-related grade 3 neutropenia in hormone receptor positive metastatic breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_557;
Permissive approach to afebrile grade 3 neutropenia and prospective clinical trials for this new dose scheme are warranted. Funding: This study was supported by a grant from Pfizer.
- tamoxifen / Generic mfg.
Impact of body mass index on the efficacy of aromatase inhibitors in patients with metastatic breast cancer (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_554;
Similarly, an exploratory analysis from the ATAC trial found that in post-menopausal women with early-stage BC, overall recurrence rates were lower in patients randomized to anastrozole versus tamoxifen but in women with body mass index (BMI) > 30, there was no significant difference in disease recurrence between anastrozole and tamoxifen...Overall, 53% were on letrozole, 42% on anastrozole and 5.5% on exemestane...This discrepancy could be due to other differences in disease characteristics that make complete aromatase inhibition more important in the adjuvant setting when disease burden is the lowest. Additional larger studies are needed to confirm this finding.
- | letrozole / Generic mfg.
Retrospective data, Journal: An Efficacy and Feasibility Analysis of Chinese Patent Medicine Combined With Letrozole in the Treatment of Women With Ovulation Disorders: A Network Meta-Analysis. (Pubmed Central) - Oct 25, 2021
The appropriate choice of treatment should be made according to the actual clinical situation. This study is registered with the International Prospective Register of Systematic Reviews (CRD42020200603).
- || Lynparza (olaparib) / Merck (MSD), AstraZeneca
Clinical, Clinical data, Journal, PARP Biomarker: Clinical Outcomes of Genotype-Matched Therapy for Recurrent Gynecological Cancers: A Single Institutional Experience. (Pubmed Central) - Oct 25, 2021
In this study, the response rate of genotype-matched therapy was 43% (3/7), which may have contributed to improved prognoses. Therefore, genotype-matched therapies may help patients with refractory gynecological cancers achieve better outcomes.