Primary analysis of a randomized phase II, multicenter trial: Neoadjuvant weekly nab-paclitaxel 100mg/m2 followed by FE100C compared with docetaxel 75mg/m2 followed by FE100C for early breast cancer in Japan.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 136-136 ◽  
Author(s):  
Takashi Kuwayama ◽  
Hideko Yamauchi ◽  
Toshimi Takano ◽  
Koichiro Tsugawa ◽  
Takanobu Sato ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Sensory Neuropathy ◽  
Operable Breast Cancer ◽  
Breast Cancer Patients ◽  
Peripheral Sensory Neuropathy ◽  
Peripheral Sensory

136 Background: Nanoparticle Albumin-Bound Paclitaxel (nab-PTX) is a new solvent free taxane-based anticancer drug. According to CA024 trial, nab-PTX 100mg/m2 demonstrated superior response to docetaxel (DTX) in patients with metastatic breast cancer. Besides, nab-PTX 100mg/m2 was less toxicity. In operable breast cancer, GeparSepto study was reported that the pCR rate were significantly higher with nab-PTX 125/150 mg/m2 compared to paclitaxel. We planned the randomized parallel design phase II trial to evaluate nab-PTX 100mg/m2in early breast cancer. Methods: Stage II-III HER2-negative breast cancer patients were included in this trial and received either 4 cycles of DTX (75 mg/m2 day1) q 3 w or 4 cycles of nab-PTX (100 mg/m2 day1/8/15) q4w followed by 4 cycles of FE100C. The primary end point is pCR (ypT0/is ypN0) rate, and the secondary end points are response rate, histological effect of treatment, breast conservation rate, and toxicity. Results: Between March 2011 to March 2014, 152 eligible patients were enrolled at 6 centers (75 pts were allocated for nab-PTX). Baseline characteristics were well balanced; median age was 51/49 years (DTX/nab-PTX), 61/61% of the patients with ER positive, 38/36% triple negative breast cancer, 57/65% Ki67 > 20%. Clinically response rate was similar to each drug. (53/57%) The pCR rate was 12/17% (p = 0.323). In TNBC group, the pCR rate was 28/30% (p = 0.866). In Ki67 > 20% group, the pCR rate was significantly higher, 16/48% (p = 0.021) with nab-PTX arm. The most common grade3-4 adverse event was neutropenia, which was observed in 40/36% of cases. Non-hematological adverse events of any grade were; 34/32% myalgia (DTX/nab-PTX), 42/35% arthralgia, 55/65% peripheral sensory neuropathy. No Grade3-4 peripheral sensory neuropathy was observed in nab-PTX arm. Infusion reaction of DTX occurred in 1 patient. Conclusions: In this initial effectively analysis, neoadjuvant weekly nab-paclitaxel 100mg/m2 were promising drug in HER2-negative operable breast cancer patients. Larger studies will be needed to evaluate neoadjuvant weekly nab-paclitaxel compared with DTX. Clinical trial information: 000005388.

Efficacy and Safety of Ixabepilone (BMS-247550) in a Phase II Study of Patients With Advanced Breast Cancer Resistant to an Anthracycline, a Taxane, and Capecitabine

2007 ◽  
Vol 25 (23) ◽  
pp. 3407-3414 ◽  
Author(s):  
Edith A. Perez ◽  
Guillermo Lerzo ◽  
Xavier Pivot ◽  
Eva Thomas ◽  
Linda Vahdat ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Objective Response ◽  
Sensory Neuropathy ◽  
Efficacy And Safety ◽  
Peripheral Sensory Neuropathy ◽  
Metastatic Setting ◽  
Grade 3 ◽  
Peripheral Sensory

PurposeTo evaluate the efficacy and safety of ixabepilone in patients with metastatic breast cancer (MBC) resistant to anthracycline, taxane, and capecitabine, in this multicenter, phase II study.Patients and MethodsPatients with measurable disease who had tumor progression while receiving prior anthracycline, taxane, and capecitabine were enrolled. Ixabepilone 40 mg/m2monotherapy was administered as a 3-hour intravenous infusion on day 1 of a 21-day cycle. The primary end point was objective response rate (ORR), assessed by an independent radiology facility (IRF).ResultsA total of 126 patients were treated and 113 were assessable for response. Patients were heavily pretreated: 88% had received at least two lines of prior chemotherapy in the metastatic setting. IRF-assessed ORR was 11.5% (95% CI, 6.3% to 18.9%) for response-assessable patients. Investigator-assessed ORR for all treated patients was 18.3% (95% CI, 11.9% to 26.1%). Fifty percent of patients achieved stable disease (SD); 14.3% achieved SD ≥ 6 months. Median duration of response and progression-free survival were 5.7 and 3.1 months, respectively. Median overall survival was 8.6 months. Patients received a median of 4.0 treatment cycles (range, one to 16 cycles), and 25% of patients received ≥ eight cycles. Grade 3/4 treatment-related events included peripheral sensory neuropathy (14%), fatigue/asthenia (13%), myalgia (8%), and stomatitis/mucositis (6%). Resolution of grade 3/4 peripheral sensory neuropathy occurred after a median period of 5.4 weeks.ConclusionIxabepilone demonstrated clear activity and a manageable safety profile in patients with MBC resistant to anthracycline, taxane, and capecitabine. Responses were durable and notable in patients who had not previously responded to multiple prior therapies.

P215 Phase II study with S-1 + low dose docetaxel (N-1 study) for operable breast cancer patients

The Breast ◽  
2015 ◽  
Vol 24 ◽  
pp. S99-S100
Author(s):  
Y. Tadokoro ◽  
M. Morimoto ◽  
M. Nakagawa ◽  
H. Takechi ◽  
A. Tangoku
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Study ◽  
Operable Breast Cancer ◽  
Breast Cancer Patients

scholarly journals P231 Phase II study on radiofrequency ablation for early breast cancer patients

The Breast ◽  
2011 ◽  
Vol 20 ◽  
pp. S54-S55
Author(s):  
S. Moto ◽  
H. Osaka ◽  
N. Sakemura ◽  
H. Ito ◽  
K. Imi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiofrequency Ablation ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Breast Cancer Patients

Preoperative radio-chemotherapy in early breast cancer patients: Long-term results of a phase II trial

2012 ◽  
Vol 102 (1) ◽  
pp. 82-88 ◽  
Author(s):  
Marc A. Bollet ◽  
Lisa Belin ◽  
Fabien Reyal ◽  
François Campana ◽  
Rémi Dendale ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Long Term Results ◽  
Breast Cancer Patients ◽  
Radio Chemotherapy

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: A phase II randomized trial

2013 ◽  
Vol 53 (1) ◽  
pp. 65-74 ◽  
Author(s):  
Whitney E. Hornsby ◽  
Pamela S. Douglas ◽  
Miranda J. West ◽  
Aarti A. Kenjale ◽  
Amy R. Lane ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Randomized Trial ◽  
Cancer Patients ◽  
Phase Ii ◽  
Aerobic Training ◽  
Operable Breast Cancer ◽  
Breast Cancer Patients ◽  
Safety And Efficacy

A pharmacogenetic analysis of peripheral sensory neuropathy related to administration of taxanes in breast cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e13133-e13133
Author(s):  
Alyson Leonard ◽  
Vinay K. Gudena
Keyword(s):  
Breast Cancer ◽  
Sensory Neuropathy ◽  
Normal Function ◽  
Categorical Variables ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Peripheral Sensory Neuropathy ◽  
Metabolizing Enzymes ◽  
Significant Difference ◽  
Peripheral Sensory

e13133 Background: Commonly used in the treatment of breast cancer, the taxane class includes paclitaxel and docetaxel. Both medications are primarily metabolized by cytochrome P450 enzymes and transporters mediate drug membrane influx and efflux. Variability in metabolizing enzymes and drug transporter function can affect drug clearance. This study sought to determine if the presence of pharmacogenetic changes in metabolizing enzymes and transporters resulted in a patient experiencing peripheral sensory neuropathy. Methods: In this case-control study, patients were enrolled between April 13, 2018 and April 30, 2018. Electronic medical records of patients with current appointments at Cone Health Cancer Center- Wesley Long were reviewed to identify patients who completed treatment with taxanes for breast cancer after January 1, 2017 for evaluation for inclusion in the study. Buccal swabs for pharmacogenetics testing were collected. Genes of interest, ABCB1, CYP3A4, CYP3A5, and SLCO1B1, were evaluated and data was categorized by phenotype. Baseline characteristics and phenotype results were compared using Fisher's exact test for categorical variables and Wilcoxon Rank Sum for numeric variables as appropriate. Results: Thirty-three patients were included in the final analysis. The population was mainly white at 72% and all patients in the study were female. The average patient age was 57 years old. Most patients had stage 1 breast cancer. Most patients received docetaxel. Among patients with peripheral sensory neuropathy, nine were grade 1, five were grade 2, and seven were grade 3. Resulting phenotypes: CYP3A5, all patients were normal metabolizers. CYP3A5, 7 normal metabolizer, 4 intermediate, and 22 poor. SLCO1B1, 25 normal function, 8 intermediate, and no low. ABCB1, 13 normal function, 7 intermediate, and 13 low. For all genes, there was no statistically significant difference in phenotype between the neuropathy and no neuropathy study arms, CYP3A5 (p = 0.075) SLCO1B1 (p = 0.106), ABCB1 (p = 0.902). Conclusions: The findings of our study indicate that having pharmacogenetics changes in the genes, ABCB1, CYP3A4, CYP3A5, and SLCO1B1 did not influence the patients experience with peripheral sensory neuropathy.

Phase II Study of S-1 Combined With Low-Dose Docetaxel as Neoadjuvant Chemotherapy for Operable Breast Cancer Patients (N-1 Study)

2019 ◽  
Vol 19 (1) ◽  
pp. 10-16 ◽  
Author(s):  
Misako Nakagawa ◽  
Mayumi Ikeuchi ◽  
Masami Morimoto ◽  
Hirokazu Takechi ◽  
Hiroaki Toba ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Cancer Patients ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Study ◽  
Operable Breast Cancer ◽  
Breast Cancer Patients
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