scholarly journals Clinical outcomes of breast cancer patients treated in phase I clinical trials at University of Colorado Cancer Center

2020 ◽  
Vol 9 (23) ◽  
pp. 8801-8808
Author(s):  
Jennifer A. Weiss ◽  
Andrew Nicklawsky ◽  
Jodi A. Kagihara ◽  
Dexiang Gao ◽  
Christine Fisher ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Phase I Clinical Trials ◽  
University Of Colorado

Patients with metastatic breast cancer enrolled in phase I clinical trials: Clinical outcomes and cohort trends.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1099-1099
Author(s):  
Jennifer Weiss ◽  
Dexiang Gao ◽  
Anthony D. Elias ◽  
Virginia F. Borges ◽  
Peter Kabos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Clinical Outcomes ◽  
Clinical Benefit ◽  
Metastatic Breast ◽  
Cancer Center ◽  
Phase I Clinical Trials ◽  
Metastatic Setting

1099 Background: Phase I clinical trials have traditionally enrolled patients with advanced solid tumors and many providers perceive the likelihood of clinical benefit as low. The purpose of this study was to evaluate clinical outcomes for patients with metastatic breast cancer enrolled on Phase I clinical trials and explore differences in outcomes for patients enrolled in all-comer versus breast cancer-specific cohorts. Methods: We performed a retrospective chart review of patients with metastatic breast cancer enrolled in Phase I clinical trials at the University of Colorado Cancer Center from 2012-2018. We included trials with Phase I and/or Phase Ib in the title. Studies or cohorts enrolling patients with ≥ 3 tumor types were considered all-comer and those with enrollment restricted to breast cancer or a breast cancer subtype were considered breast cancer-specific. Results: A total of 208 patients were enrolled in Phase I clinical trials, 168 in breast cancer-specific cohorts and 40 in all-comer trials. Patients on average were 56.9 years old (range 31-79), 98.6% (205/208) female, 1.4% (3/208) male, 57.2% ER+/Her2-, 30.1% ER-/Her2- and 11.1% Her2+. Patients received on average 2.1(range 0-10) prior lines of chemotherapy in the metastatic setting. Patients enrolled on Phase I clinical trials remained on study without progression on average for 138 days (CI 95%, 112.64 to 163.91). Patients enrolled on breast cancer-specific studies remained on study for 152 days (CI 95%, 120.66 to 182.56) compared to 82 days (CI 95%, 59.43 to 105.13) for those enrolled on all-comer trials, p< 0.05. Patients went off study for disease progression (83.17%), adverse events (7.69%), and other (9.14%), including withdrawal of consent. Conclusions: Patients with metastatic breast cancer previously treated with multiple lines of chemotherapy in the metastatic setting enrolled in Phase I clinical trials received clinical benefit from treatment that is favorable compared to historical controls of late-line chemotherapy. The majority of patients were treated on breast cancer-specific cohorts consistent with trends in Phase I trial design including more tumor specific cohorts.

scholarly journals Clinical Outcomes for Patients With Metastatic Breast Cancer Treated With Immunotherapy Agents in Phase I Clinical Trials

2021 ◽  
Vol 11 ◽  
Author(s):  
Anna R. Schreiber ◽  
Jodi A. Kagihara ◽  
Jennifer A. Weiss ◽  
Andrew Nicklawsky ◽  
Dexiang Gao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Clinical Outcomes ◽  
Single Agent ◽  
Metastatic Breast ◽  
Phase I Clinical Trials ◽  
University Of Colorado ◽  
The University

BackgroundImmuno-oncology (IO) agents have demonstrated efficacy across many tumor types and have led to change in standard of care. In breast cancer, atezolizumab and pembrolizumab were recently FDA-approved in combination with chemotherapy specifically for patients with PD-L1-positive metastatic triple-negative breast cancer (TNBC). However, the single agent PD-1/PD-L1 inhibitors demonstrate only modest single agent efficacy in breast cancer. The purpose of this study was to investigate the efficacy of novel IO agents in patients with metastatic breast cancer (MBC), beyond TNBC, treated in phase I clinical trials at the University of Colorado.MethodsWe performed a retrospective analysis using a database of patients with MBC who received treatment with IO agents in phase I/Ib clinical trials at the University of Colorado Hospital from January 1, 2012 to July 1, 2018. Patient demographics, treatments and clinical outcomes were obtained.ResultsWe identified 43 patients treated with an IO agent either as a single agent or in combination. The average age was 53 years; 55.8% had hormone receptor-positive/HER2-negative breast cancer, 39.5% TNBC and 4.7% HER2-positive. Patients received an average of 2 prior lines of chemotherapy (range 0-7) in the metastatic setting. Most patients (72.1%) received IO alone and 27.9% received IO plus chemotherapy. Median progression-free survival (PFS) was 2.3 months and median overall survival (OS) was 12.1 months. Patients remaining on study ≥ 6 months (20.9%) were more likely to be treated with chemotherapy plus IO compared to patients with a PFS &lt; 6 months (77.8% v. 14.7%). No differences in number of metastatic sites, prior lines of chemotherapy, breast cancer subtype, absolute lymphocyte count, or LDH were identified between patients with a PFS ≥ 6 months vs. &lt; 6 months.ConclusionsOur phase I experience demonstrates benefit from IO therapy that was not limited to patients with TNBC and confirms improved efficacy from IO agents in combination with chemotherapy. A subset of patients with MBC treated in phase I clinical trials with an IO agent derived prolonged clinical benefit. Predictors of response to immunotherapy in breast cancer remain uncharacterized and further research is needed to identify these factors.

Clinical implications of genomic-directed therapies by comprehensive genomic profiling in breast cancer patients at a large academic cancer center.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12037-e12037
Author(s):  
Ricardo Daniel Parrondo ◽  
Veronica Mariotti ◽  
Miguel Gonzalez Velez ◽  
Lori Ann Leslie
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Pik3ca Mutation ◽  
Clinical Impact ◽  
Cancer Center ◽  
Genomic Profiling ◽  
Breast Cancer Patients ◽  
Comprehensive Genomic Profiling ◽  
Genomic Characterization

e12037 Background: Increased use of comprehensive genomic profiling (CGP) has recently led to improved genomic characterization of tumors, increased access to individualized therapies and increased availability of clinical trials in breast cancer patients. The aim of this study was to evaluate the clinical impact of genomic profiling in breast cancer patients with the use of a CGP assay at a large cancer center. Methods: We retrospectively analyzed 101 consecutive breast cancer patients who received CGP at the John Theurer Cancer Center between 12/2011 and 08/2016. Genomic alterations (GAs) were identified using the FoundationOne assay (Foundation Medicine, Cambridge, MA). GAs, number of available genomic-directed therapies and number of available clinical trials were reviewed. The CGP interrogated up to 315 genes and introns of 28 genes. Results: Median age at diagnosis was 58 years (range: 35-83 years). With a median follow-up of 189 months (range 1-189), median survival was 163 months (range 142-184). A total of 560 GAs were found in our population, with a median of 5.0 GAs/sample (range 0-16), a median of 2.0 therapies/patient (range 0-11), and a median of 11.0 clinical trials/patient (range 0-36). The most frequent GAs found were TP53 (47.5%, n = 48), PIK3CA (34.7%, n = 35), MYC (22.8%, n = 23), CCND1 (19.8%, n = 20), FGF3 (16.8%, n = 17), FGF4 (15.8%, n = 16), and ZNF703 (14.9%, n = 15). A significant positive correlation was found between number of GAs and the number of available targeted therapies and clinical trials (r = 0.5 and r = 0.7, p = 0.00, respectively). Increasing age is a predictor of having a PIK3CA mutation (OR = 1.05; CI:1.01-1.09, p = 0.00) while decreasing age is a predictor of having a MYC mutation by logistic regression (OR = 0.95; CI:0.91-0.95, p = 0.03). Conclusions: The systematic use of CGP led to the identification of a high number of GAs, which correlated with a median of 2.0 individualized therapies and a median of 11.0 clinical trials available for breast cancer patients. The clinical impact of genomic-directed individualized therapies needs to be further investigated in prospective, randomized studies.

scholarly journals Clinical Outcomes and Survival of Advanced Renal Cancer Patients in Phase I Clinical Trials

2014 ◽  
Vol 12 (5) ◽  
pp. 359-365 ◽  
Author(s):  
Laeeq Malik ◽  
Helen Parsons ◽  
Devalingam Mahalingam ◽  
Benjamin Ehler ◽  
Martin Goros ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Renal Cancer ◽  
Phase I Clinical Trials ◽  
Advanced Renal Cancer

Clinical outcomes of patients with metastatic breast cancer enrolled in phase I clinical trials

2021 ◽  
Vol 157 ◽  
pp. 40-49
Author(s):  
Carmen Criscitiello ◽  
Antonio Marra ◽  
Stefania Morganti ◽  
Paola Zagami ◽  
Sara Gandini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Clinical Outcomes ◽  
Metastatic Breast ◽  
Phase I Clinical Trials

Abstract A70: Clinical outcomes and survival of advanced renal cancer patients in Phase I clinical trials.

2013 ◽  
Author(s):  
Laeeq Malik ◽  
Helen Parsons ◽  
Devalingam Mahalingam ◽  
Benjamin Ehler ◽  
Martin Goros ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Renal Cancer ◽  
Phase I Clinical Trials ◽  
Advanced Renal Cancer
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