scholarly journals Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hanna Huebner ◽  
Christian M. Kurbacher ◽  
Geoffrey Kuesters ◽  
Andreas D. Hartkopf ◽  
Michael P. Lux ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Menopausal Status ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Patient Characteristics ◽  
Breast Cancer Patients ◽  
Patient Identification ◽  
Eligibility Criteria

Abstract Background Eligibility criteria are a critical part of clinical trials, as they define the patient population under investigation. Besides certain patient characteristics, clinical trials often include biomarker testing for eligibility. However, patient-identification mostly relies on the trial site itself and is often a time-consuming procedure, which could result in missing out on potentially eligible patients. Pre-selection of those patients using a registry could facilitate the process of eligibility testing and increase the number of identified patients. One aim with the PRAEGNANT registry (NCT02338167) is to identify patients for therapies based on clinical and molecular data. Here, we report eligibility testing for the SHERBOC trial using the German PRAEGNANT registry. Methods Heregulin (HRG) has been reported to identify patients with better responses to therapy with the anti-HER3 monoclonal antibody seribantumab (MM-121). The SHERBOC trial investigated adding seribantumab (MM-121) to standard therapy in patients with advanced HER2-negative, hormone receptor–positive (HR-positive) breast cancer and HRG overexpression. The PRAEGNANT registry was used for identification and tumor testing, helping to link potential HRG positive patients to the trial. Patients enrolled in PRAEGNANT have invasive and metastatic or locally advanced, inoperable breast cancer. Patients eligible for SHERBOC were identified by using the registry. Study aims were to describe the HRG positivity rate, screening procedures, and patient characteristics associated with inclusion and exclusion criteria. Results Among 2769 unselected advanced breast cancer patients, 650 were HER2-negative, HR-positive and currently receiving first- or second-line treatment, thus potentially eligible for SHERBOC at the end of current treatment; 125 patients also met further clinical eligibility criteria (e.g. menopausal status, ECOG). In the first/second treatment lines, patients selected for SHERBOC based on further eligibility criteria had a more favorable prognosis than those not selected. HRG status was tested in 38 patients, 14 of whom (36.8%) proved to be HRG-positive. Conclusion Using a real-world breast cancer registry allowed identification of potentially eligible patients for SHERBOC focusing on patients with HER3 overexpressing, HR-positive, HER2-negative metastatic breast cancer. This approach may provide insights into differences between patients eligible or non-eligible for clinical trials. Trial registration Clinicaltrials, NCT02338167, Registered 14 January 2015 - retrospectively registered.

Gemcitabine and docetaxel combination regimen in metastatic breast cancer (MBC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1107-1107
Author(s):  
D. Karacetin ◽  
O. Maral ◽  
O. Aksakal ◽  
B. Okten ◽  
B. Yalçın ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Response Rate ◽  
Menopausal Status ◽  
Metastatic Breast ◽  
Complete Response ◽  
Combination Regimen ◽  
Breast Cancer Patients ◽  
Grade 3

1107 Background: No standart chemotherapy regimen has been estabilished for the treatment of patients with metastatic breast cancer. The gemcitabine and docetaxel combination has been shown to be synergistic . This study is conducted to verify the clinical efficacy and safety of gemcitabine and docetaxel combination therapy in metastatic breast cancer. Methods: 27 metastatic breast cancer patients were treated with gemcitabine-docetaxel combination . Gemcitabine 1,250 mg/m2 IV infusion, on day 1 and 8, and docetaxel 70 mg/m2 on day 1 in 21 day cycles. 4–6 cycles of chemotherapy were repeated every 3 weeks. The primary endpoint was response rate, and survival. Results: The median age was 50 years (range,32–77). Performans status (ECOG) was 0–1. Hormone receptor status: ER+/ER-; 11/16, PR+/PR-; 14/13. Menopausal status were: 11 premenopausal, 16 postmenopausal. Of the 27 evaluable patients, there were 11 (40.7%) partial responses and no complete response. Overall response rate was 40.7%. Median time to progression was 7 months, and median survival was 14 months. Toxicities included grade 3–4 neutropenia in 9 (30%), thrombocytopenia in 6 (22%), anemia in 3(9%). There were no treatment releated deaths Conclusions: The combination of gemcitabine and docetaxel has shown favorable toxicity profile and promising activity in metastatic breast cancer patients. No significant financial relationships to disclose.

Effect of nanosomal docetaxel lipid suspension (NDLS) on response rate compared to docetaxel: A randomized phase II study in patients with locally advanced or metastatic breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 577-577
Author(s):  
Ateeq Ahmad ◽  
Saifuddin Sheikh ◽  
Rakesh Taran ◽  
Shanti P Srivastav ◽  
Krishna Prasad ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Treatment Group ◽  
Cancer Patients ◽  
Response Rate ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Increase Response Rate ◽  
Breast Cancer Patients ◽  
Docetaxel Treatment

577 Background: Docetaxel formulated inpolysorbate 80 and ethanol (Docetaxel) is among the most active agents in the treatment of breast cancer. The primary rationale for developing nanosomal docetaxel lipid suspension (NDLS) is to improve the drug’s safety profile by eliminating polysorbate 80 and ethanol from docetaxel formulation. Previously, we conducted a clinical study comparing pharmacokinetic parameters of NDLS and docetaxel at 75 mg/m2. The log transformed NDLS/docetaxel ratio for Cmax and AUC0-t was 149.3% and 119.3% respectively. The higher systemic availability of NDLS prompted us to conduct current efficacy study. Methods: 72 locally advanced or metastatic breast cancer patients were enrolled into the study after failure of prior chemotherapy. The mean age for the enrolled patients was 47 years and the racial make-up of the study was 100% Asian. Patients were administered NDLS or docetaxel at 75 mg/m2 as per randomization schedule, by IV infusion for one hour in each cycle of 21 days. Each patient received maximum of 6 cycles of NDLS or docetaxel. No premedication was given to the patients in NDLS treatment group. Results: Safety - The total number of post-dose AEs observed in the study was 510. The breakdown by treatment groups is as follows: AEs were reported in 91.30% and 93.88% patients who received the docetaxel and NDLS respectively. There were 34 SAEs in the study, out of which 04 SAEs resulted in death of the patients (3 in docetaxel and 1 in NDLS). Efficacy - The results showed that 4.2% patients had complete response (CR) in NDLS treatment group while there was no CR in docetaxel treatment group. Further, 31.3% partial response rate (PR) was observed in NDLS treatment group and 26.3% in docetaxel treatment group. Overall response (CR+PR) rate was 35.4% in NDLS treatment group and 26.3% in docetaxel treatment group. Stable disease (SD) was observed in 45.8% patients in NDLS group and 63.2% patients in docetaxel group. Conclusions: Overall, the NDLS was well tolerated in the multiple doses of 75 mg/m2 and found to increase response rate compared to docetaxel in breast cancer patients. Clinical trial information: CTRI/2010/091/000610.

scholarly journals Role of Curcumin in reducing toxicity and adverse effects in locally advanced and metastatic breast cancer patients

2019 ◽  
Vol 30 ◽  
pp. vi126-vi127
Author(s):  
Shekhar Goyal ◽  
Surender Kr Beniwal ◽  
H.S. Kumar ◽  
Dhruv Kumar ◽  
B.C. Das
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adverse Effects ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Breast Cancer Patients

scholarly journals Elevated plasma levels of TGF-beta1 in patients with locally advanced breast cancer related to other clinical stages

2003 ◽  
Vol 11 (3) ◽  
pp. 131-133 ◽  
Author(s):  
Natasa Todorovic-Rakovic ◽  
Vesna Ivanovic ◽  
Miroslav Demajo ◽  
Zora Neskovic-Konstantinovic ◽  
Dragica Nikolic-Vukosavljevic
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Cancer Patients ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Disease Course ◽  
Breast Cancer Patients ◽  
Healthy Donors

Background: The application of plasma tumor markers is mainly during the follow-up of cancer patients and especially in monitoring of advanced disease. These biomarkers do not require surgical intervention and provide relatively simple monitoring at any time during the disease course. TGF-beta1 is a pluripotent cytokine, with diverse effects in normal physiology and a role in both normal mammary gland development and progression of breast cancer. In early stages of breast carcinomas TGF-beta1 acts as tumor suppressor, while in later stages, when tumor cells become resistant to growth inhibition by TGF-beta1, it acts as tumor promoter. For that reason, the aim of this study was to assess the stage-related TGF-beta1 elevation in circulation of breast cancer patients, during disease progression. Methods: We analyzed 52 breast cancer patients of different stages (I/II, III, IV) and 36 healthy donors. TGF-beta1 levels were determined by enzyme-linked immunosorbent assay (ELISA, R&D). Results Although there was no increase in plasma TGF-beta1 in stage I/II patients (n =10, median value = 0.89 ng/ml), statistically significant elevation of plasma TGF-beta1 was found in locally advanced breast cancer (stage III, n = 9, median value = 2.30 ng/ml) and also in metastatic breast cancer (stage IV, n = 33, median value = 2.46 ng/ml) in relation to healthy donors and stage I/II. Conclusion: This elevation of plasma TGF-beta1 in locally advanced breast cancer is probably the result of increased tumor mass and tumor-stromal interactions in this stage, as well as a possible cause of greater metastatic potential of tumor cells which lead to metastatic breast cancer. Prognostic role of TGF-beta1 is not fully understood, but from these results we could say that it could be a marker for monitoring patients disease course, as well as for understating the biology of breast cancer.

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