scholarly journals Neo-CheckRay: radiation therapy and adenosine pathway blockade to increase benefit of immuno-chemotherapy in early stage luminal B breast cancer, a randomized phase II trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Alex De Caluwé ◽  
Laurence Buisseret ◽  
Philip Poortmans ◽  
Dirk Van Gestel ◽  
Roberto Salgado ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Primary Breast Tumor ◽  
Immune Priming ◽  
Luminal B ◽  
Randomized Phase Ii ◽  
The Impact

Abstract Background Residual breast cancer after neo-adjuvant chemotherapy (NACT) predicts disease outcome and is a surrogate for survival in aggressive breast cancer (BC) subtypes. Pathological complete response (pCR) rate, however, is lower for luminal B BC in comparison to the triple negative (TNBC) and HER2+ subtypes. The addition of immune checkpoint blockade (ICB) to NACT has the potential to increase pCR rate but is hampered by the lower immunogenicity of luminal B BC. Novel strategies are needed to stimulate the immune response and increase the response rate to ICB in luminal B BC. Methods The Neo-CheckRay trial is a randomized phase II trial investigating the impact of stereotactic body radiation therapy (SBRT) to the primary breast tumor in combination with an anti-CD73 (oleclumab) to increase response to anti PD-L1 (durvalumab) and NACT. The trial is designed as a three-arm study: NACT + SBRT +/− durvalumab +/− oleclumab. The result at surgery will be evaluated using the residual cancer burden (RCB) index as the primary endpoint. Six patients will be included in a safety run-in, followed by a randomized phase II trial that will include 136 evaluable patients in 3 arms. Inclusion is limited to luminal B breast cancers that are MammaPrint genomic high risk. Discussion combination of ICB with chemotherapy in luminal B BC might benefit from immune priming agents to increase the response rate. As none have been identified so far, this phase II trial will evaluate SBRT and oleclumab as potential immune priming candidates. Trial registration trial registered on ClinicalTrials.gov (NCT03875573) on March 14th, 2019.

The impact of cetuximab on the gemcitabine/cisplatin combination in first-line treatment of EGFR-positive advanced pancreatic cancer (APC): A randomized phase II trial of GISCAD

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4544-4544 ◽  
Author(s):  
S. Cascinu ◽  
R. Berardi ◽  
S. Siena ◽  
R. Labianca ◽  
A. Falcone ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
First Response ◽  
Randomized Phase Ii ◽  
Meta Analyses ◽  
The Impact ◽  
Egfr Antibody

4544 Background: Cetuximab, an EGFR antibody inhibitor, has been shown to increase the activity of gemcitabine (GEM) in APC. Based on data from randomised trials and meta-analyses suggesting that the combination of a GEM with a platinum analog significantly improves survival as compared to GEM alone, we assessed the activity and feasibility of a combination of GEM/cisplatin (CDDP) plus cetuximab. Methods: Multicenter, randomised two-arm phase II trial: GEM 1,000 mg/m2 day 1,8 and CDDP 35 mg/m2 day 1,8 every 21 days alone or in combination with cetuximab 250 mg/m2 weekly after a loading dose of 400 mg/m2. Treatment was limited to a maximum of 9 cycles. With 37 patients in each arm the power was 90% to select the truly better arm if the true between arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until June 2005. Results: We present here the results of 74 patients including in the study. In all the patients, the first response rate are available (investigators’ assessment after 3 cycles) as well as toxicity data. Conclusions: Cetuximab does not seem to positively interact with GEM/CDDP combination in terms of activity especially concerning time to progression. Although toxicity was not increased by cetuximab, this combination should not be assessed in a phase III trial.The trial was supported in part by by Merck KGaA. [Table: see text] No significant financial relationships to disclose.

Caesium137 implant as sole radiation therapy for operable breast cancer: a phase II trial

2004 ◽  
Vol 71 (3) ◽  
pp. 281-285 ◽  
Author(s):  
Ian S Fentiman ◽  
Vinay Deshmane ◽  
David Tong ◽  
John Winter ◽  
Helen Mayles ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Operable Breast Cancer

Randomized Phase II Trial of Docetaxel Plus Thalidomide in Androgen-Independent Prostate Cancer

2004 ◽  
Vol 22 (13) ◽  
pp. 2532-2539 ◽  
Author(s):  
William L. Dahut ◽  
James L. Gulley ◽  
Philip M. Arlen ◽  
Yinong Liu ◽  
Katherine M. Fedenko ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Molecular Weight ◽  
Phase Ii ◽  
Low Molecular Weight Heparin ◽  
Phase Ii Trial ◽  
Low Molecular Weight ◽  
Randomized Phase Ii ◽  
The Impact ◽  
Docetaxel Group ◽  
Androgen Independent

Purpose Both docetaxel and thalidomide have demonstrated activity in androgen-independent prostate cancer (AIPC). We compared the efficacy of docetaxel to docetaxel plus thalidomide in patients with AIPC. Methods Seventy-five patients with chemotherapy-naïve metastatic AIPC were randomly assigned to receive either docetaxel 30 mg/m2 intravenously every week for 3 consecutive weeks, followed by a 1-week rest period (n = 25); or docetaxel at the same dose and schedule, plus thalidomide 200 mg orally each day (n = 50). Prostate-specific antigen (PSA) consensus criteria and radiographic scans were used to determine the proportion of patients with a PSA decline, and time to progression. Results After a median potential follow-up time of 26.4 months, the proportion of patients with a greater than 50% decline in PSA was higher in the docetaxel/thalidomide group (53% in the combined group, 37% in docetaxel-alone arm). The median progression-free survival in the docetaxel group was 3.7 months and 5.9 months in the combined group (P = .32). At 18 months, overall survival in the docetaxel group was 42.9% and 68.2% in the combined group. Toxicities in both groups were manageable after administration of prophylactic low-molecular-weight heparin in the combination group. Conclusion In this randomized phase II trial, the addition of thalidomide to docetaxel resulted in an encouraging PSA decline rate and overall median survival rate in patients with metastatic AIPC. After the prophylactic low-molecular-weight heparin was instituted to prevent venous thromboses, the combination regimen was well tolerated. Larger randomized trials are warranted to assess the impact of this combination.

scholarly journals A randomized phase II trial of MOVING ON: An intervention to increase exercise outcome expectations among breast cancer survivors

2018 ◽  
Vol 27 (10) ◽  
pp. 2450-2457 ◽  
Author(s):  
Rachel Hirschey ◽  
Gretchen Kimmick ◽  
Marilyn Hockenberry ◽  
Ryan Shaw ◽  
Wei Pan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Phase Ii ◽  
Breast Cancer Survivors ◽  
Phase Ii Trial ◽  
Outcome Expectations ◽  
Randomized Phase Ii
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