Predictive significance of an optimized panel for basal-like breast cancer: Results from the Canadian Cancer Trials Group MA.5 and MA.12 phase III clinical trials

2021 ◽  
pp. clincanres.1942.2021
Author(s):  
Karama Asleh ◽  
Dongsheng Tu ◽  
Dongxia Gao ◽  
Vivien Bramwell ◽  
Mark N. Levine ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Basal Like Breast Cancer ◽  
Cancer Trials

scholarly journals Gender and sex disparity in cancer trials

ESMO Open ◽  
2020 ◽  
Vol 5 (Suppl 4) ◽  
pp. e000773 ◽  
Author(s):  
Eudocia Lee ◽  
Patrick Wen
Keyword(s):  
Clinical Trials ◽  
Elderly Women ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Phase Iii Clinical Trials ◽  
The Usa ◽  
Study Population ◽  
Cancer Trials ◽  
Early Phase Clinical Trials ◽  
Sex Disparity

The study population within phase III clinical trials leading to approval of new cancer agents should ideally more closely mirror the population who will ultimately receive these agents. Although the number of females participating in clinical trials has increased over the past several decades, females are still under-represented in preclinical studies, in early phase clinical trials and even in some later phase cancer clinical trials. In the USA, this is particularly true for women from minority populations and elderly women. In this review, we review gender and sex disparities in cancer trials, the reasons for these disparities, the barriers to clinical trial enrolment and ways to improve diversity in cancer clinical trials.

scholarly journals EP-1192: Assessment of quality of life in phase III clinical trials of radiation therapy in breast cancer

2017 ◽  
Vol 123 ◽  
pp. S645-S646
Author(s):  
G.N. Marta ◽  
F.Y. Moraes ◽  
E.T. Leite ◽  
E. Chow ◽  
D. Cella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Phase Iii ◽  
Phase Iii Clinical Trials

A review of clinical endpoints and use of quality-of-life outcomes in phase III metastatic breast cancer clinical trials.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 129-129
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Clinical Endpoints ◽  
Phase Iii Clinical Trials ◽  
The Impact

129 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with most interventions intended to relieve disease symptoms, minimize treatment effects and prolong patient survival. The impact of disease and treatment on a patient's funcitonal abilities has led to an emphasis of incorporating quality of life (QoL) measures into clinical trials. The main objective of this study is to evaluate phase III clinical trials in MBC, and assess the inclusion of QOL as an endpoint, in addition to conventional efficacy endpoints. Methods: A structured PubMed search was conducted to identify phase III clinical trials published between Jan. 1990 and Aug. 2011, evaluating systemic treatment in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a particular focus on progression-based (PB), overall survival (OS), and QoL endpoints. Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. While the inclusion of QoL was not associated with the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as a clinical endpoint (p=0.016). When stratified by treatment arm, it was found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management and treatment decisions, only one-third of identified phase III clinical trials included an assessment of QoL. About half of these trials showed no statistically significant differences in the QoL endpoint; of not, instruments of varying validity were utilized. There needs to be a greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.

Comparison of [99mTc] tilmanocept and [99mTc] sulfur colloid for identification of sentinel lymph nodes in clinically node-negative breast cancer patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 11098-11098
Author(s):  
Jennifer L. Baker ◽  
Minya Pu ◽  
Christopher A. Tokin ◽  
Karen Messer ◽  
Carl Hoh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Lymph Node ◽  
Cancer Patients ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Sulfur Colloid ◽  
Node Negative ◽  
Phase Iii Clinical Trials ◽  
Node Negative Breast Cancer

11098 Background: Receptor-targeted (CD206) [99mTc] tilmanocept is a radiopharmaceutical specifically engineered for sentinel lymph node (SLN) identification that has recently completed phase III clinical trials. The agent has been compared to vital blue dye in prior studies, but has not yet been compared to radio-labeled sulfur colloid. We compared the performance of [99mTc]tilmanocept vs. filtered [99mTc]sulfur colloid (fTcSC) in two cohorts of clinically node-negative breast cancer patients (BCP) who underwent SLN mapping at a single institution. Outcomes were degree of SLN localization and % positive nodes among those removed. Methods: The [99mTc]tilmanocept cohort was composed of UCSD-specific patients pooled from two phase III clinical trials (Jun 2008-Jun 2009, Jul 2010-Apr 2011); the fTcSC cohort was composed of consecutive BCP undergoing SLN mapping at UCSD (Mar 2011-Feb 2012). Demographic, lymph node-specific, and cancer characteristics were compared between groups. A zero-inflated binomial model compared %-positive nodes among nodes removed. Results: There were 85 vs.120 patients in the [99mTc]tilmanocept and fTcSC cohorts, respectively. The groups did not differ in demographic or clinicopathologic factors predictive of axillary metastatic disease (age, race, cancer stage, histologic subtype and grade, hormone and HER2-Neu status or presence of lymphovascular invasion). The [99mTc]tilmanocept group had significantly fewer SLNs removed (mean 1.9 vs. 3.9, p<0.001), achieved higher gamma counts/node (28 vs. 1.6 kcps, p<0.001), and detected a significantly higher percent of tumor-positive SLNs (73% vs. 49%, p=0.016) while identifying the same rate of node-positive patients (24% vs. 18%, p=0.4). Conclusions: [99mTc]Tilmanocept identified the same rate of node positive patients and removed fewer SLNs compared to fTcSC among BCP with similar risk of axillary metastatic disease. These data suggest that [99mTc]tilmanocept more precisely targets true SLNs and may minimize morbidity while maintaining or improving the accuracy of axillary staging in clinically node-negative breast cancer patients.

Efficacy and toxicity of CDK 4/6 inhibitors in breast cancer: Systematic review and meta-analysis of the phase III clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14591-e14591 ◽  
Author(s):  
Faheem Farooq ◽  
Jules A. Cohen
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Treatment Discontinuation ◽  
Phase Iii ◽  
Cochrane Library ◽  
Line Treatment ◽  
Treatment Trials ◽  
Phase Iii Clinical Trials ◽  
Grade 3

e14591 Background: Selective CDK4/6 inhibitors such as palbociclib, abemaciclib, and ribociclib have demonstrated efficacy in advanced HR+/HER2- breast cancer. Drug-related toxicity has been manageable, but variable amongst the drugs. This meta-analysis was conducted to guide CDK inhibitor choice based on efficacy and toxicity. Methods: A systematic literature review of Pubmed, Cochrane Library, and EMBASE was performed in December 2018. Efficacy was evaluated via reported progression free survival (PFS) and pooled hazard ratios (HR). Overall response rate (ORR), treatment discontinuation, and treatment-related adverse events (AEs) were measured via pooled odds ratios (OR). Meta-analyses were performed using random effects modeling and 95% confidence intervals (CI). Results: A pooled analysis of 7 phase III clinical trials (n = 4415) demonstrated a HR of 0.55 (CI: 0.51-0.60) for PFS and an OR of 1.93 (CI: 1.54-2.42) for ORR. First-line treatment trials (n = 3020) pairing CDK 4/6 inhibitors with NSAI/tamoxifen had a HR of 0.56 (CI: 0.51-0.60) for prolonged PFS and an OR of 1.64 (CI: 1.39-1.95) for ORR. Second-line treatment trials (n = 1916) pairing CDK 4/6 inhibitors with fulvestrant had an HR of 0.54 (CI: 0.48-0.61) for prolonged PFS and an OR of 2.48 (CI: 1.57-3.90) for ORR. Palbociclib and ribociclib had similar rates of grade 3/4 AEs, neutropenia, and treatment discontinuation. Abemaciclib had lower rates of grade 3/4 AEs overall, but significantly increased rates of diarrhea and treatment discontinuation due to AEs. Conclusions: Each drug demonstrated a significant improvement in PFS. However, there is no statistical difference in efficacy among the three CDK inhibitors. Treatment decisions can be guided by the tolerability of AEs amongst the medications. Further patient follow-up will illuminate whether there is an OS advantage in this novel drug class. [Table: see text]

scholarly journals Complementary medicine (CM) use in phase III clinical trials (P3T) conducted by the Canadian Cancer Trials Group (CCTG)

2019 ◽  
Vol 30 ◽  
pp. v720 ◽  
Author(s):  
J.C. Wells ◽  
A. Sidhu ◽  
K. Ding ◽  
D.Y.C. Heng ◽  
F. Shepherd ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Complementary Medicine ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Cancer Trials

A review of clinical endpoints and use of quality of life outcomes in phase III metastatic breast cancer clinical trials.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16547-e16547
Author(s):  
Raman Tatla ◽  
Denis Landaverde ◽  
Charles Victor ◽  
David Miles ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Clinical Endpoints ◽  
Phase Iii Clinical Trials ◽  
The Impact

e16547 Background: The management of metastatic breast cancer (MBC) is often considered to be palliative, with therapy used to relieve disease symptoms, minimize treatment effects and prolong survival. The impact of disease and treatment on patients has led to an emphasis of quality of life (QoL) measures in clinical trials. This study’s primary objective is to evaluate phase III clinical trials in MBC, and assess the inclusion of QoL as an endpoint. Methods: A PubMed search was conducted to identify phase III clinical trials published from Jan 1990 to Aug 2011, which evaluated systemic therapy in MBC patients. Data pertaining to treatment regimens, study endpoints and clinical findings were collected, with a focus on progression-based (PB), overall survival (OS), and QoL endpoints. The instrument(s) used to evaluate QoL were also noted (if applicable). Results: Of 520 publications identified, 122 phase III MBC clinical trials met the inclusion criteria. Of these studies, 98.4% and 95.9% included PB and OS respectively, as clinical endpoints, while QoL was assessed in only 46 (37.7%) studies. 14 instruments were identified as QoL tools among the studies, with EORTC QLQ-C30 and FACT-B accounting for 54.7% of the instruments used. While the inclusion of QoL was not related to the significance of PB results, there was an association between the inclusion of QoL and OS results, with 59% of significant OS studies and 32% of non-significant OS studies including QoL as an endpoint (p=0.016). Stratification by treatment arm found that studies favouring standard therapy were more likely to include QoL (75%, p=0.045), compared to those favouring the intervention (56%), and those without significant differences (32%). Conclusions: Although the importance of QoL is often emphasized in MBC management, only one-third of identified phase III clinical trials included its assessment. Half of these trials showed no statistically significant differences in QoL endpoint; of note, instruments of varying validity were utilized. There needs to be greater emphasis on the evaluation of QoL, with the use of standard and validated QoL tools in MBC clinical trials, especially as we increasingly focus on progression-based endpoints.

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