A phase II study of gemcitabine and liposomal doxorubicin (Lipo-Dox) as first line chemotherapy in the treatment of metastatic breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10688-10688
Author(s):  
N. Yao ◽  
W. Kao ◽  
T. Chao ◽  
R. Hsieh ◽  
J. Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Stable Disease ◽  
Liposomal Doxorubicin ◽  
Overall Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Metastatic Breast ◽  
Overall Response

10688 Background: To determine the overall objective response rate (ORR) of Lipo-Dox plus Gemcitabine in patients with metastatic breast cancer. Patients and Methods: We are conducting an open-label, non-comparative phase II clinical trial in Simon’s 2-stage optimal design to assess the efficacy and the safety of the treatment with Gemcitabine (Gems) plus Liposomal Doxorubicin (Lipo-Dox) in patients with metastatic breast cancer. All eligible subjects received Lipo-Dox 25 mg/m2 intravenous infusion over 1 hr and follow by gemcitabine 800 mg/m2 intravenously (iv) over 30 minutes on day 1, and receive gemcitabine 800 mg/m2 intravenously (iv) over 30 minutes only on day 8 in a 21-day cycle. Results: Between July 2004 and December 2005, a total of 21 patients were enrolled in the study and total of 136 cycles of chemotherapy were delivered with a median of six per patients (range 1–16). 17 patients (80.8%) who had at least one post-treatment evaluation and exposed to at least two cycles of treatment were included in this report. Characteristics of the 17 patients: All females; median age 52 years (range 36 - 68); 16 pts had a performance status (PS) of 0 or 1 and 1 had a PS of 2 (ECOG scale); Histology: All metastatic breast cancer. The response assessment of the 17 patients: Complete response was observed in 2, partial response in 5, stable disease in 8, and progressive disease in 2 patients. Overall response rate was 41.17%. Major grade 3/4 hematological toxicities were neutropenia in 9 pts, thrombocytopenia in 2 pt and leukopenia in 5 pts. Peripheral neuropathy was noted in 1 patient (grade 2). Other toxicities occurred during the treatment cycles were all manageable or tolerable. Patient recruitment, treatment and follow-up are still ongoing. Conclusion: Liposomal Doxorubicin used in the regimen reduces the incidence of alopecia (hair loss) to grade 1 compare to the conventional doxorubicin. This study, with an overall response rate of 41.1% (CR+PR) and a rate of stable disease of 47.05%, has shown a good activity with mild and acceptable toxicities of Gemcitabine (Gems) plus Liposomal Doxorubicin (Lipo-Dox) regimen in patients with metastatic breast cancer. No significant financial relationships to disclose.

scholarly journals Pyrotinib or Lapatinib Combined With Capecitabine in HER2–Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study

2019 ◽  
Vol 37 (29) ◽  
pp. 2610-2619 ◽  
Author(s):  
Fei Ma ◽  
Quchang Ouyang ◽  
Wei Li ◽  
Zefei Jiang ◽  
Zhongsheng Tong ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Her2 Positive ◽  
Overall Response ◽  
Randomized Phase Ii

PURPOSE Pyrotinib, an irreversible pan-ErbB inhibitor, showed promising antitumor activity and acceptable tolerability in a phase I trial. We assessed the efficacy and tolerability of pyrotinib versus lapatinib, both in combination with capecitabine, in women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer in an open-label, multicenter, randomized phase II study. PATIENTS AND METHODS Chinese patients with HER2-positive relapsed or metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab were assigned (1:1) to receive 400 mg pyrotinib or lapatinib 1,250 mg orally once per day for 21-day cycles in combination with capecitabine (1,000 mg/m2 orally twice per day on days 1 to 14). The primary end point was investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. RESULTS Between May 29, 2015, and March 15, 2016, 128 eligible patients were randomly assigned to the pyrotinib (n = 65) or lapatinib (n = 63) treatment groups. The overall response rate was 78.5% (95% CI, 68.5% to 88.5%) with pyrotinib and 57.1% (95% CI, 44.9% to 69.4%) with lapatinib (treatment difference, 21.3%; 95% CI, 4.0% to 38.7%; P = .01). The median progression-free survival was 18.1 months (95% CI, 13.9 months to not reached) with pyrotinib and 7.0 months (95% CI, 5.6 to 9.8 months) with lapatinib (adjusted hazard ratio, 0.36; 95% CI, 0.23 to 0.58; P < .001). The most frequent grade 3 to 4 adverse events were hand-foot syndrome in 16 of 65 patients (24.6%) in the pyrotinib group versus 13 of 63 (20.6%) in the lapatinib group; diarrhea in 10 patients (15.4%) versus three patients (4.8%), respectively; and decreased neutrophil count in six patients (9.2%) versus two patients (3.2%), respectively. CONCLUSION In women with HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines, and/or trastuzumab, pyrotinib plus capecitabine yielded statistically significant better overall response rate and progression-free survival than lapatinib plus capecitabine in this randomized phase II trial.

A phase II study of weekly nanoparticle albumin-bound paclitaxel combined with cisplatin in patients with metastatic breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11568-e11568
Author(s):  
Biyun Wang ◽  
Xi-Chun Hu ◽  
Si Sun ◽  
Jian Zhang ◽  
Lichen Tang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Triple Negative ◽  
Response Rate ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Primary Objective ◽  
Overall Response

e11568 Background: This prospective phase II study was to investigate the efficacy and toxicity of weekly albumin-bound paclitaxel (nab-paclitaxel) and cisplatin combination in patients with metastatic breast cancer. Methods: Females with unresectable, recurrent or metastatic breast cancer were eligible for participation. Nab-paclitaxel was administered weekly at a dose of 125 mg/m2 on d1, 8, 15, followed by cisplatin 75 mg/m2 on d1, repeated every 28 days with a maximum of 6 cycles. The primary objective was overall response rate (ORR) and the second objectives were progression free survival (PFS), safety, and overall survival (OS). Results: Seventy-three women were enrolled into this study. A total of 384 chemotherapy cycles were administered with a median of 6 cycles. A high overall response rate (67.1%) was achieved in the whole population. The highest response rate was observed in the first line patients (80.6%) and in patients who had not received taxane previously (80%). After a median follow-up of 12.8 months, the median PFS was 10.5 months. For the patients receiving first-, second- and third-line or more,median PFS was 12.3, 9.0 and 7.7 months, respectively (P=0.006). Subgroup analysis showed that the highest response rate was obtained in Her-2 positive patients, followed by patients with triple negative and luminal subtypes, yielding a response rate of 77.8%, 68.8% and 63.9%, respectively (P=0.584). The corresponding median PFS was 13.6, 12.7 and 10.0 months, respectively (P=0.83). While grade 4 neutropenia occurred in 46 patients (63.0%), febrile neutropenia occurred only in 9 patients (12.3%). Grade 3 peripheral neuropathy was an accumulated dose-limiting toxicity occurring in 19 patients (26.0%), 13 of whom had to stop chemotherapy due to no recovery to grade 2 or less within 2 weeks. Other common toxicities included alopecia, nausea, vomiting and rash. Conclusions: The results of this trial add to the clinical evidence that doublet of nab-paclitaxel and cisplatin has high efficacy and a good safety profile in treatment of patients with metastatic breast cancer. Further evaluation of this regimen in metastatic breast cancer, especially triple negative subtype, is justified.

Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1101-1101 ◽  
Author(s):  
J. S. Link ◽  
J. R. Waisman ◽  
B. Nguyen ◽  
C. I. Jacobs
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Stable Disease ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Brain Lesion ◽  
Metastatic Breast ◽  
Significant Activity ◽  
Pet Ct

1101 Background: Miller, et al demonstrated the combination of bevacizumab and paclitaxel has significant activity in metastatic breast cancer. Because paclitaxel albumin bound (PAB) has been shown to have less toxicity, a better tumor delivery and possibly better response for metastatic breast cancer, we combined it with bevacizumab (B) to treat women with metastatic breast cancer. Methods: This is a retrospective analysis. Billing records from March 2005 through December 2006 were reviewed to obtain all patients treated consecutively with a combination of PAB (80–125mg/m2 days 1,8,15 or 170–200 mg/m2 every 14 days on a 28 day cycle) and B (10mg/kg every 14 days). A total of 40 women were identified. A minimum of two courses were given. All women had received a minimum of 3 prior chemotherapy regimens including anthracyclines 34/40 and taxanes 35/40. Patients were monitored for response using RECIST criteria based on PE, and PET/CT imaging. Six women with bone only disease were monitored with PET, CT/MRI and tumor markers. All response data were confirmed by independent review. Results: 20 women had objective responses to the PAB/B regimen (3CRs and 17PRs) for an overall response rate of 50%. Another seven women had stable disease (SD) for a mean duration of 212 days. Thirteen women progressed. The mean time to progression for the responders was 132 days. Toxicity was acceptable with fatigue (9 gr 2), neuropathy (4 gr 2, 1 gr 3), anemia (2 gr 2, 2 gr 3), and hypertension (3 gr 2) being the most common complaints. Two patients were discontinued due to a possible CNS hemorrhage into a metastatic brain lesion. There were no other treatment discontinuations due to non-tolerance Conclusions: In our limited series of consecutive woman with advanced, heavily pretreated metastatic breast cancer treated with PAB (Abraxane) and bevacizumab (Avastin), we saw a 50% objective response rate (3CR, 17PR). The regimen was well tolerated with acceptable toxicity. Another seven women had stable disease for an average duration of >200days giving an objective response rate + SD of 67%. No significant financial relationships to disclose.

Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015

Chemotherapy ◽  
2017 ◽  
Vol 62 (5) ◽  
pp. 307-313 ◽  
Author(s):  
Jun Yamamura ◽  
Norikazu Masuda ◽  
Daigo Yamamoto ◽  
Shigeru Tsuyuki ◽  
Masahide Yamaguchi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Breast Cancer Patients ◽  
Free Survival

Background: This phase II study was conducted to evaluate the efficacy and safety of the chemotherapy combination of gemcitabine and vinorelbine in taxane-pretreated Japanese metastatic breast cancer patients. Methods: In this multicenter, phase II, single-arm study, patients with recurrent or metastatic HER2-negative breast cancer were administered gemcitabine (1,200 mg/m2) and vinorelbine (25 mg/m2) intravenously on days 1 and 8 every 3 weeks. The primary endpoint was the objective response rate, and other endpoints included progression-free survival, overall survival, and safety. Results: A total of 42 patients were enrolled in this study. The objective response rate and clinical benefit rate were 24 and 43%, respectively. The median progression-free survival was 4.0 months. The median overall survival was 11.1 months. Grade 3/4 neutropenia was the most common hematologic toxicity, occurring in 22 patients (54%). Nonhematologic toxicity was moderate and transient, with fatigue (48%) being the most common condition and no severe adverse event reported. Conclusion: The combination of gemcitabine and vinorelbine is an effective and tolerable regimen for HER2-negative, taxane-pretreated, metastatic breast cancer patients in Japan.

Phase II trial of paclitaxel and cisplatin in women with advanced breast cancer: an active regimen with limiting neurotoxicity.

1996 ◽  
Vol 14 (7) ◽  
pp. 1993-1999 ◽  
Author(s):  
C Wasserheit ◽  
A Frazein ◽  
R Oratz ◽  
J Sorich ◽  
A Downey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Advanced Breast ◽  
Median Response ◽  
Overall Response

PURPOSE A phase II study of paclitaxel and cisplatin in patients with advanced breast cancer was performed to determine the objective response rate and make further observations about the toxicity of this regimen. PATIENTS AND METHODS Patients were required to have histologically proven adenocarcinoma of the breast with no more than one chemotherapeutic treatment for advanced disease. Treatment consisted of paclitaxel 200 mg/m2 administered as a 24-hour intravenous (i.v.) infusion followed by cisplatin 75 mg/m2 i.v. Patients received granulocyte colony-stimulating factor (G-CSF) 5 micrograms/kg subcutaneously on day 3 until WBC recovery. Cycles were repeated every 21 days. Patients continued to receive therapy until disease progression or unacceptable toxicity. RESULTS Forty-four patients entered the trial. Forty-two patients were assessable for response. Nineteen patients (43%) had no prior chemotherapy and 41 had no chemotherapy for metastatic disease. The median number of cycles administered per patient was five (range, one to seven). There were five complete responses (CRs) (11.9%) and 17 partial responses (PRs) (40.5%), with an overall response rate of 52.4% (95% confidence interval [CI], 36.4% to 68.0%). Nine patients had stage III disease. The response rate for this group was 66.7% (95% CI, 33.0% to 92.5%), with three CRs and three PRs. Among 35 patients with stage IV disease, there were two CRs and 14 PRs, with an overall response rate of 48.5% (95% CI, 30.8% to 66.5%). Overall, the median response duration was 10.6 months. Thirty patients (68%) developed transient grade 4 neutropenia. Cumulative neuropathy was the major dose-limiting toxicity. After five cycles of chemotherapy, 96% of patients had at least grade 1 neurotoxicity and 52% had at least grade 2 neurotoxicity. One patient had a toxic death after cycle 1 of therapy. CONCLUSION The combination of paclitaxel and cisplatin as first-line chemotherapy for women with advanced breast cancer is an active regimen. However, the cumulative neurotoxicity was significant and dose-limiting in the majority of patients.

A phase II study of weekly gemcitabine and docetaxel in first and second line metastatic breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10668-10668
Author(s):  
C. Isaacs ◽  
A. Wang ◽  
R. Warren ◽  
M. Wilkinson ◽  
G. Grana ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Metastatic Breast ◽  
Second Line ◽  
Phase Ii Trials ◽  
Overall Response ◽  
Metastatic Setting

10668 Background: Combination chemotherapy for metastatic breast cancer has generally been demonstrated to be associated with a higher response rate than single agent therapy, however such therapy is often accompanied by increased toxicity. Thus there is a need to develop well-tolerated combination chemotherapy regimens. Gemcitabine and docetaxel are both active agents in the treatment of this disease, and are effective and well tolerated when administered on a weekly basis. The purpose of this study was to evaluate the therapeutic efficacy and toxicity of weekly gemcitabine and docetaxel as first or second line treatment of metastatic breast cancer (MBC). Methods: Patients with measurable MBC who had received no more than 1 prior chemotherapy regimen in the metastatic setting were treated with gemcitabine 800 mg/m2 and docetaxel 30 mg/m2 on days 1 and 8 every 21 days without growth factor support. Results: Thirty-one patients were enrolled. Twenty-nine patients were evaluable for toxicity and 25 for efficacy. Median age was 55 (range 30 to 79). Visceral disease was the dominant site in 74% of patients. Doxorubicin and paclitaxel were previously administered in 74% and 48% of patients respectively. The overall response rate was 56% (complete response in 1 patient and partial responses in 13 patients). Stable disease was evident in 10 additional patients (38.4%). The progression free survival was 35 weeks (range 9 to 101 weeks) and the median overall survival was 17 months. Treatment was well tolerated with the majority of toxicities being grade 1 or 2 (85%). The only grade 3 (G3) or 4 (G4) toxicities observed were neutropenia in 14 participants (G3 41%; G4 7%), anemia in 4 (13%), G3 elevated transaminases in 3 (10%), G3 thrombocytopenia in 1 (3%), G3 flu-like symptoms in 2 (7%) and G3 edema in 1 (3%). Conclusions: The regimen of gemcitabine 800 mg/m2 and docetaxel 30 mg/m2 given two weeks out of three for MBC showed excellent overall response of 56% with very good tolerability. The findings from our trial compare well to the response rates of 36% to 79% seen in prior phase II trials utilizing higher doses of this combination chemotherapy. [Table: see text]

Docetaxel Combined With Trastuzumab Is an Active Regimen in HER-2 3+ Overexpressing and Fluorescent In Situ Hybridization–Positive Metastatic Breast Cancer: A Multi-Institutional Phase II Trial

2004 ◽  
Vol 22 (6) ◽  
pp. 1071-1077 ◽  
Author(s):  
K.L. Tedesco ◽  
A.D. Thor ◽  
D.H. Johnson ◽  
Y. Shyr ◽  
K.A. Blum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Metastatic Breast Cancer ◽  
Fluorescent In Situ Hybridization ◽  
Overall Response Rate ◽  
Response Rate ◽  
Metastatic Breast ◽  
Overall Response ◽  
Her 2

Purpose To determine the efficacy and safety of weekly docetaxel and trastuzumab as first- or second-line therapy in women with HER-2–overexpressing metastatic breast cancer and to correlate the efficacy of trastuzumab with HER-2 status as determined by immunohistochemistry assay and fluorescent in situ hybridization (FISH). Patients and Methods Twenty-six women with HER-2–positive (HercepTest [Dako Corp, Carpenteria, CA]2 to 3+) metastatic breast cancer were enrolled onto this study of trastuzumab (4 mg/kg load; 2 mg/kg/wk administered intravenously) and docetaxel (35 mg/m2/wk for 6 weeks). Results Using an intent-to-treat analysis, the overall response rate was 50% (13 of 26 patients). Eight patients (31%) had a period of stable disease posttherapy. Among HER-2 3+ patients, the overall response rate was 63% (12 of 19 patients) compared with a 14% response rate (one of seven patients) for HER-2 2+ patients (P = .07). Patients with FISH-positive tumors experienced an overall response rate of 64%. Median time to progression was 12.4 months for the entire cohort (HER-2 3+ tumors, 12.3 months; HER-2 2+ lesions, 9.5 months) and median survival was 22.1 months. All HER-2 3+ patients were FISH-positive; the only HER-2 2+ patient responding to treatment was also FISH-positive. Grade 4 toxicities occurred in four patients; most toxicities were mild. Conclusion Trastuzumab plus docetaxel is an active and well-tolerated regimen in women with HER-2 3+ overexpressing or FISH-positive metastatic breast cancer.

Phase II study of bavituximab plus docetaxel in patients with locally advanced or metastatic breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 3005-3005
Author(s):  
D. Tabagari ◽  
G. Nemsadze ◽  
M. Jincharadze ◽  
M. Janjalia ◽  
J. S. Shan
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Back Pain ◽  
Overall Response Rate ◽  
Response Rate ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Stage Iv ◽  
Anionic Phospholipid ◽  
Overall Response

3005 Background: Phosphatidylserine (PS) is an anionic phospholipid normally present on the inside surface of cell membranes. PS becomes exposed on the outside surface of tumor endolethial cells. Bavituximab (B) is a novel anti-PS monoclonal antibody and has demonstrated preclinical synergistic antitumor activity when used in combination with docetaxel. Methods: This Simon 2-stage trial is designed to determine the overall response rate (CR+PR) in patients with locally advanced or metastatic breast cancer to a combination of weekly bavituximab (3 mg/kg) plus docetaxel (35 mg/m2) on days 1, 8, 15 of a 28-day cycle for up to 6 cycles. Following completion of docetaxel, weekly bavituximab is continued until progression or toxicity. If ≥ 6 responses are observed in the 15 pt enrolled to Stage A, an additional 31 pts will be enrolled to Stage B. Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. Results: Data are available for the 15 female pts enrolled in Stage A of the trial. Median age was 49 years;13 had stage IV and 2 had recurrent/progressive stage III breast cancer at study entry. All patients received prior chemotherapy, 13 had surgery, 7 had hormone therapy and 5 had prior radiotherapy. Patients received a median of 6 cycles of treatment. All patients reported at least one AE, to date. The most common AEs (regardless of severity or causality) were alopecia, epistaxis, fatigue, back pain, diarrhea, nasal dryness, infusion related reaction, arthralgia, pyrexia, stomatitis and nail bed bleeding. Grade 3 drug-related AEs were back pain, headache, DVT (discontinued study treatment at week 3) and chest pain (SAE) starting during a docetaxel infusion, which recurred after completion of bavituximab, reported in one patient each. Using RECIST, the overall response rate in these 15 pt is 67% (95% confidence interval, 38–88%) for the intent-to-treat group and 71% (95% CI, 42–92%) for the 14 evaluable patients. All responses were confirmed at least 4 weeks later. Conclusions: Bavituximab plus docetaxel achieved an encouraging response rate in advanced/metastatic breast cancer in Stage A of this study. Enrollment in Stage B of the trial is expected to be completed with preliminary results available by the annual meeting. [Table: see text]

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