scholarly journals Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

2017 ◽  
Vol 77 (08) ◽  
pp. 870-878 ◽  
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Data Entry ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Patient Reported ◽  
Trial Staff ◽  
Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

2017 ◽  
Vol 14 (04) ◽  
pp. 221-230
Author(s):  
Markus Wallwiener ◽  
Felix Heindl ◽  
Sara Brucker ◽  
Florin-Andrei Taran ◽  
Andreas Hartkopf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Data Entry ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Patient Reported ◽  
Trial Staff ◽  
Breast Cancer Registry

Abstract Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ-5D-5L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patients’ compliance was better with some questionnaires, butothers may present difficulties.

scholarly journals An economic evaluation of eribulin for advanced breast cancer treatment based on the Southeast Netherlands advanced breast cancer registry

2020 ◽  
Vol 59 (9) ◽  
pp. 1123-1130
Author(s):  
Xavier G. L. V. Pouwels ◽  
Bram L. T. Ramaekers ◽  
Sandra M. E. Geurts ◽  
Frans Erdkamp ◽  
Birgit E. P. J. Vriens ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Economic Evaluation ◽  
Cancer Treatment ◽  
Advanced Breast Cancer ◽  
Cancer Registry ◽  
Breast Cancer Treatment ◽  
Advanced Breast ◽  
Breast Cancer Registry

scholarly journals Updates on managing advanced breast cancer with palbociclib combination therapy

2018 ◽  
Vol 10 ◽  
pp. 175883591879384 ◽  
Author(s):  
Teresa M. McShane ◽  
Thomas A. Wolfe ◽  
Joanne C. Ryan
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Metastatic Breast ◽  
Clinical Trial Data ◽  
Progression Free Survival ◽  
Advanced Breast ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Patient Reported ◽  
Subgroup Analyses

Background: The objective of this study was to review the pharmacology, efficacy, and safety of palbociclib, a first-in-class cyclin-dependent kinase 4/6 inhibitor, for the management of advanced breast cancer (ABC). Methods: Pharmacokinetics and drug interactions associated with palbociclib are described. Recent clinical trial data are reviewed, including patient-reported outcomes and subgroup analyses. Results: Palbociclib is indicated in combination with an aromatase inhibitor as initial endocrine therapy (ET) or with fulvestrant for patients with disease progression following ET for hormone receptor positive, human epidermal growth factor receptor 2 negative ABC or metastatic breast cancer. Palbociclib inhibits cyclin-dependent kinases 4/6, resulting in a blockade of phosphorylation of the retinoblastoma protein, which hinders the activation of transcription factors involved in S-phase entry, thereby arresting cell cycle progression at G1 phase. The efficacy and safety of palbociclib in combination with ET was established in three randomized trials (PALOMA-1, -2, and -3); all studies met their primary endpoint of significantly prolonging investigator-assessed progression-free survival versus ET alone. Findings were similar in subgroup analyses of the three PALOMA studies. Palbociclib plus ET also maintained health-related quality of life (QoL) compared with ET alone in PALOMA-2 and -3. A long-term safety profile for palbociclib, up to 3 years, has been established. Neutropenia, the most common any-grade and grade 3 or higher adverse event associated with palbociclib, is consistent with the drug’s mechanism of action and can be effectively managed with dose interruption, dose reduction, or delay in starting treatment cycles. Conclusions: Palbociclib in combination with ET improved progression-free survival and QoL in patients with ABC, including in several patient subgroups.

Targeted tumor-derived cellular immunotherapy in advanced breast cancer patients induces initial immune responses and tumor regression.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 6-6
Author(s):  
Vivekananda Sunkari ◽  
William Williams ◽  
George Peoples ◽  
Sanne Graeve ◽  
Charles Wiseman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Advanced Breast Cancer ◽  
Tumor Regression ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Delayed Type Hypersensitivity ◽  
Sera Samples

6 Background: SV-BR-1-GM is a GM-CSF secreting breast cancer cell line which also expresses HLA class I & II antigens. In a previous clinical trial, a partial response of widely metastatic breast cancer was seen in a patient who allele-matched SV-BR-1-GM at HLA-DRB3. Here we report regression of metastatic breast cancer and efficacy analysis with immunologic correlates in subjects of a Phase I/IIa trial of SV-BR-1-GM in patients with advanced breast cancer. Methods: 24 patients with recurrent and/or metastatic breast cancer refractory to standard therapies have been dosed with SV-BR-1-GM in a Phase I/IIa trial. Patients who have undergone at least one cycle of SV-BR-1-GM therapy were analyzed. Patients first received low-dose cyclophosphamide, then intradermal injection of SV-BR-1-GM (20-40x106 cells/four sites) with interferon-α injected into inoculation sites (10,000 IU/site) ~2 & 4 days subsequently. Immunologic responses were measured by delayed type hypersensitivity (DTH) after inoculation and IgG titers of antibodies against SV-BR-1 were measured in sera samples collected prior to and after the first dose of SV-BR-1-GM by flow cytometry. Results: 24 patients have been inoculated with SV-BR-1-GM cells with no unexpected adverse events. None of the patients exhibited immediate hypersensitivity to SV-BR-1. DTH response was recorded in 18 subjects till date, of these, 61% exhibited DTH to cell inoculations. The patient with the most marked DTH response, 01-002, also had a clinical response with regression of multiple lung metastases. Two other patients had evidence of tumor regression (tumor regression is matched SV-BR-1-GM at least at one HLA allele). Sera samples from 6 patients were evaluated and found to contain anti-SV-BR-1 antibodies. Conclusions: SV-BR-1-GM in this regimen appears to be safe and well-tolerated. Initial analysis of SV-BR-1-GM showed significant DTH and antibody responses. HLA matching improves the response rate and is being evaluated as a predictor of response. Clinical trial information: NCT03066947.

A phase II clinical trial of talazoparib monotherapy for PALB2 mutation-associated advanced breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS1109-TPS1109
Author(s):  
Joshua James Gruber ◽  
Wyatt Gross ◽  
Alex McMillan ◽  
James M. Ford ◽  
Melinda L. Telli
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Recist 1.1 ◽  
Palb2 Mutation

TPS1109 Background: PALB2 (Partner and Localizer of BRCA2) plays a critical role in the maintenance of genomic integrity through its role in the Fanconi anemia and homologous recombination DNA repair pathways. Our recently reported phase II clinical trial (Gruber, et al. JCO 2019) showed that talazoparib monotherapy was associated with single agent activity in germline PALB2 (gPALB2) mutation-associated advanced breast cancers. Of 5 patients with a germline PALB2 mutation, all 5 had reduction in target lesions > 20% with 3 of 5 achieving a RECIST 1.1 response. All patients had visceral metastases and were heavily pretreated; one response occurred in a patient with 8 prior lines of therapy for metastatic breast cancer. Clinical activity of the PARP inhibitor olaparib was also demonstrated in breast cancer patients with gPALB2 mutations in the Olaparib Expanded trial (TBCRC 048). Thus, we believe there is significant value in generating additional PARP inhibitor monotherapy data in subjects with advanced PALB2 mutation-associated breast cancer. We propose this phase II trial to better estimate the rate of RECIST 1.1 objective response in this patient population. Methods: This is a single-arm, two-stage, non-randomized study to assess the objective response rate (ORR) of talazoparib monotherapy in patients with PALB2 mutation-associated advanced breast cancer. Eligible subjects will be adults with inoperable locally advanced or metastatic breast cancer with a germline or somatic PALB2 mutation with 0-3 prior therapies for advanced disease. Eligible patients must have a deleterious or suspected deleterious mutation in PALB2 on a CLIA approved commercial germline or next generation sequencing tumor assay. Study treatment is talazoparib 1 mg PO daily. In stage 1, ORR will be assessed after 15 patients; if at least 2 responses are observed then an additional 15 patients will be enrolled; if less than 2 responses are observed the study will be terminated. The primary objective is to evaluate whether talazoparib monotherapy can induce a 30% ORR in subjects with advanced breast cancer associated with a PALB2 mutation. Response will be assessed by RECIST 1.1. Secondary objectives include safety, PFS, clinical benefit rate, and patient-reported quality-of-life. Exploratory endpoints will assess for the presence of PALB2 loss-of-heterozygosity, biallelic mutations, correlation of ctDNA profile with treatment response and the correlation of germline versus somatic mutations with response rate. This trial is currently activated and enrolling at Stanford Cancer Center and it is expected that 4 additional sites will be added. Conclusion: This trial will evaluate gPALB2 as a biomarker for PARP inhibitor monotherapy in advanced or metastatic HER2- breast cancer. Clinical trial information: pending .

Plasma ESR1 Mutations and the Treatment of Estrogen Receptor–Positive Advanced Breast Cancer

2016 ◽  
Vol 34 (25) ◽  
pp. 2961-2968 ◽  
Author(s):  
Charlotte Fribbens ◽  
Ben O’Leary ◽  
Lucy Kilburn ◽  
Sarah Hrebien ◽  
Isaac Garcia-Murillas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Advanced Breast Cancer ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Phase Iii ◽  
Wild Type ◽  
Estrogen Receptor Positive ◽  
Esr1 Mutations ◽  
The Impact

Purpose ESR1 mutations are selected by prior aromatase inhibitor (AI) therapy in advanced breast cancer. We assessed the impact of ESR1 mutations on sensitivity to standard therapies in two phase III randomized trials that represent the development of the current standard therapy for estrogen receptor–positive advanced breast cancer. Materials and Methods In a prospective-retrospective analysis, we assessed ESR1 mutations in available archived baseline plasma from the SoFEA (Study of Faslodex Versus Exemestane With or Without Arimidex) trial, which compared exemestane with fulvestrant-containing regimens in patients with prior sensitivity to nonsteroidal AI and in baseline plasma from the PALOMA3 (Palbociclib Combined With Fulvestrant in Hormone Receptor–Positive HER2-Negative Metastatic Breast Cancer After Endocrine Failure) trial, which compared fulvestrant plus placebo with fulvestrant plus palbociclib in patients with progression after receiving prior endocrine therapy. ESR1 mutations were analyzed by multiplex digital polymerase chain reaction. Results In SoFEA, ESR1 mutations were found in 39.1% of patients (63 of 161), of whom 49.1% (27 of 55) were polyclonal, with rates of mutation detection unaffected by delays in processing of archival plasma. Patients with ESR1 mutations had improved progression-free survival (PFS) after taking fulvestrant (n = 45) compared with exemestane (n = 18; hazard ratio [HR], 0.52; 95% CI, 0.30 to 0.92; P = .02), whereas patients with wild-type ESR1 had similar PFS after receiving either treatment (HR, 1.07; 95% CI, 0.68 to 1.67; P = .77). In PALOMA3, ESR1 mutations were found in the plasma of 25.3% of patients (91 of 360), of whom 28.6% (26 of 91) were polyclonal, with mutations associated with acquired resistance to prior AI. Fulvestrant plus palbociclib improved PFS compared with fulvestrant plus placebo in both ESR1 mutant (HR, 0.43; 95% CI, 0.25 to 0.74; P = .002) and ESR1 wild-type patients (HR, 0.49; 95% CI, 0.35 to 0.70; P < .001). Conclusion ESR1 mutation analysis in plasma after progression after prior AI therapy may help direct choice of further endocrine-based therapy. Additional confirmatory studies are required.

Sign in / Sign up

Export Citation Format

Share Document