Abstract P4-06-29: Prospective immune-profiling of locally advanced and metastatic breast cancer patients

2019 ◽  
Author(s):  
BA Sezen ◽  
S Koca ◽  
O Alan ◽  
S Renzullo ◽  
FT Ozdemir ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Immune Profiling

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 Efficacy and Safety of the All-Oral Schedule of Metronomic Vinorelbine and Capecitabine in Locally Advanced or Metastatic Breast Cancer Patients: The Phase I-II VICTOR-1 Study

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
M. E. Cazzaniga ◽  
V. Torri ◽  
F. Villa ◽  
N. Giuntini ◽  
F. Riva ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Fixed Dose ◽  
Toxicity Profile ◽  
Breast Cancer Patients

Background. Vinorelbine (VRB) and capecitabine (CAPE) are demonstrated to be active in pretreated metastatic breast cancer patients. Different studies have demonstrated that the metronomic treatment is active with an acceptable toxicity profile. We designed a Phases I-II study to define the MTD of oral metronomic, VRB, and CAPE.Patients and Methods. Phase I: fixed dose of CAPE was 500 mg thrice a day, continuously. Level I of VRB was 20 mg/tot thrice a week for 3 weeks (1 cycle). Subsequent levels were 30 mg/tot and 40 mg/tot (Level III), respectively, if no Grades 3-4 toxicity were observed in the previous level. Phase II: further 32 patients received the MTD of VRB plus CAPE for a total of 187 cycles to confirm toxicity profile.Results. 12 patients were enrolled in Phase I and 22 in Phase II. Phase I: the MTD of VRB was 40 mg. Phase II: 187 cycles were delivered, observing 5.9% of Grades 3-4 toxicity. 31 patients are evaluable for efficacy, obtaining a clinical benefit rate of 58.1%.Conclusion. MTD of VRB with fixed dose of CAPE was 40 mg thrice a week and was the recommended dose for the ongoing Phase II multicenter study.

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