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 in patients with metastatic breast cancer: a phase II study of the National Cancer Institute of Canada-Clinical Trials Group.

1996 ◽  
Vol 14 (2) ◽  
pp. 422-428 ◽  
Author(s):  
M E Trudeau ◽  
E A Eisenhauer ◽  
B P Higgins ◽  
F Letendre ◽  
W S Lofters ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
National Cancer Institute ◽  
Response Rate ◽  
Phase Ii Study ◽  
Metastatic Breast

PURPOSE The National Cancer Institute of Canada-Clinical Trials Group (NCIC-CTG) conducted a phase II study to assess the efficacy and toxicity of docetaxel as first-line chemotherapy in metastatic breast cancer (MBC). PATIENTS AND METHODS Fifty-one patients with measurable MBC were studied. Three patients were ineligible and were excluded from analysis. The planned dose of docetaxel was 100 mg/m2 intravenously (i.v.) every 3 weeks. Prior adjuvant chemotherapy was allowed if at least 12 months had elapsed from completion of treatment to recurrence. RESULTS The most severe toxicity was granulocytopenia. Ten patients (20.8%) were hospitalized for febrile neutropenia. The protocol was amended to a starting dose of 75 mg/m2 for the last 16 patients. Sixty percent of patients experienced hypersensitivity reactions (HSRs). After two protocol amendments, the use of a premedication regimen of oral dexamethasone and i.v. H1 and H2 blockers prevented significant HSRs. Edema developed in 62% of patients and was cumulative, was present in 50% who received greater than 400 mg/m2, and was not improved by premedication regimens. Following an independent radiology review, 22 partial remissions and four complete responses in 47 assessable patients were confirmed (response rate, 55%; 95% confidence interval [CI], 40% to 69%). The response rate for 15 assessable patients registered at 75 mg/m2 was 40% (95% CI, 16% to 67%); for 32 assessable patients registered at 100 mg/m2, the response rate was 63%, (95% CI, 43% to 78%). CONCLUSION Docetaxel is an active agent in MBC. Its activity as a single agent is comparable to many combination chemotherapy regimens and is not affected by prior adjuvant chemotherapy. Studies are ongoing to improve its therapeutic index and to incorporate docetaxel in combination chemotherapy regimens.

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.

scholarly journals Phase II Studies of Gemcitabine and Cisplatin in Heavily and Minimally Pretreated Metastatic Breast Cancer

2009 ◽  
Vol 27 (13) ◽  
pp. 2163-2169 ◽  
Author(s):  
Helen K. Chew ◽  
James H. Doroshow ◽  
Paul Frankel ◽  
Kim A. Margolin ◽  
George Somlo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Genetic Polymorphisms ◽  
Phase Ii ◽  
Response Rate ◽  
Single Agent ◽  
Metastatic Breast ◽  
High Dose ◽  
Phase Ii Trials ◽  
Heavily Pretreated

Purpose Cisplatin and gemcitabine have single-agent activity in metastatic breast cancer, and preclinical data support synergy of the combination. Two parallel, phase II trials were conducted to evaluate the response rate, response duration, and toxicities of the combination. Genetic polymorphisms were analyzed for correlation with outcomes. Patients and Methods Eligible women had measurable disease and heavily or minimally pretreated metastatic breast cancer. The heavily pretreated protocol required prior anthracycline and taxane therapy; cisplatin as part of high-dose therapy was allowed. All patients received cisplatin 25 mg/m2 on days 1 through 4 and gemcitabine 1,000 mg/m2 on days 2 and 8 of a 21-day cycle with prophylactic granulocyte colony-stimulating factor in the heavily pretreated group. Sera from a subset of patients were evaluated by polymerase chain reaction restriction fragment length polymorphism for polymorphisms in 10 genes of interest. Results Of 136 women enrolled, 74 were heavily pretreated. Both protocols accrued to their two-stage design. The response rate for both the heavily and minimally pretreated cohorts was 26%, and the median durations of response were 5.3 and 5.9 months, respectively. In a multivariate analysis, hormone receptor–negative disease was associated with a higher response rate. The most common grades 3 or 4 toxicities were thrombocytopenia (71%), neutropenia (66%), and anemia (38%). In a subset of 55 patients, the xeroderma pigmentosum group D (XPD)–751, x-ray cross-complementing group 3 (XRCC3) and cytidine deaminase polymorphisms were significantly associated with clinical outcomes. Conclusion Combination cisplatin and gemcitabine is active in metastatic breast cancer regardless of prior therapy. Genetic polymorphisms may tailor which patients benefit from this regimen.

Gemcitabine/paclitaxel compared to gemcitabine/vinorelbine in metastatic breast cancer: An interim analysis

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1097-1097 ◽  
Author(s):  
A. Bensalem ◽  
K. Bouzid
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Overall Response Rate ◽  
Response Rate ◽  
Metastatic Breast ◽  
Stage Iv ◽  
New Drugs ◽  
Combination Regimen ◽  
Overall Response ◽  
Metastatic Setting

1097 Background: New combinations and strategies have been developed over the past 10 years including new drugs such as taxanes and gemcitabine. It is not clear whether the activity of the gemcitabine-paclitaxel (GP) combination regimen would translate into better progression-free or overall survival (OS) when compared with gemcitabine-vinorelbine (GV) especially in metastatic breast cancer. This study was conducted to evaluate the overall response rate (RR) of GP Vs GV. Secondary objectives included individual responses of GP and GV, time to progression (TTP), time to treatment failure (TTF), OS, and toxicities. Methods: Patients(pts) with histological diagnosis of stage IV or recurrent breast cancer who had PS =2 and measurable disease were randomized to receive GP (Gemcitabine: 1,250mg/m2 D1 & D8- paclitaxel: 175 mg/m2 D1, D1=D28) or GV (Gemcitabine: 1,250mg/m2 D1 & D8 - vinorelbine: 25mg/m2 D1 & D8, D1=D21). Pts received anthracycline and/or capecitabine chemotherapy in adjuvant and/or metastatic setting. Results: Of 47 patients enrolled, 24 patients were randomized to GP arm and 23 to GV arm. 72% of patients were stage IV and 28% recurrent disease. To date, all patients were qualified for safety, TTF, TTP and OS analysis. Hematologic toxicities were: Neutropenia in 23% in GP Vs 17% in GV, Anemia in 12% in GP Vs 9% in GV. Non hematologic toxicities were essentially nausea and vomiting grad 2–3 in 27% in GP Vs 31% in GV. Anti-emetic agents were administrated to decrease them. The Complete Response (CR) was 27% in GP Vs 30% in GV, the Partial Response (PR) was 23% in GP Vs 17% in GV; with an Overall Response Rate (ORR) of 50% in GP Vs 47% in GV. Median TTF in weeks was 12 in GP Vs 14 in GV. Median TTP (weeks) was 14 in GP Vs 19 in GV. Median OS (weeks) was 32 in GP Vs 50 in GV. Conclusions: In our experience, schedules incriminating gemcitabine are efficient and produce clinical benefit and there activities are very interesting. The analysis of the useful of paclitaxel or vinorelbine associated to gemcitabine demonstrates that these associations are active with no significant differences in toxicities. Therefore, the questions are what regimens, for what patients to what high responses in pre-treated metastatic breast cancer. No significant financial relationships to disclose.

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.

A phase II trial of docetaxel (Taxotere®) as second-line chemotherapy in patients with metastatic breast cancer

2007 ◽  
Vol 134 (2) ◽  
pp. 125-135 ◽  
Author(s):  
Martina Baur ◽  
Allan T. van Oosterom ◽  
Véronique Diéras ◽  
Michele Tubiana-Hulin ◽  
R. Charles Coombes ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

Safety and Efficacy of Using a Single Agent or a Phase II Agent Before Instituting Standard Combination Chemotherapy in Previously Untreated Metastatic Breast Cancer Patients: Report of a Randomized Study—Cancer and Leukemia Group B 8642

1999 ◽  
Vol 17 (5) ◽  
pp. 1397-1397 ◽  
Author(s):  
Mary E. Costanza ◽  
Raymond B. Weiss ◽  
I. Craig Henderson ◽  
Larry Norton ◽  
Donald A. Berry ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Single Agent ◽  
Metastatic Breast ◽  
Response Rates ◽  
Breast Cancer Patients ◽  
Safety And Efficacy

PURPOSE: We undertook a prospective, randomized phase III trial to evaluate the safety and efficacy of using a phase II agent before initiating therapy with standard combination chemotherapy in metastatic breast cancer patients. PATIENTS AND METHODS: A total of 365 women with measurable metastatic breast cancer, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either immediate chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil (CAF) or up to four cycles of one of five sequential cohorts of single-agent drugs: trimetrexate, melphalan, amonafide, carboplatin, or elsamitrucin, followed by CAF. RESULTS: The toxicity of each single agent followed by CAF was comparable to that of CAF alone. The cumulative response rates for the single agent followed by CAF were not statistically different from those of CAF alone (44% v 52%; P = .24). However, in the multivariate analysis, patients with visceral disease had a trend toward lower response rates on the phase II agent plus CAF arm (P = .078). Although survival and response duration also were not statistically significantly different between the two study arms (P = .074 and P = .069, respectively), there was a suggestion of benefit for the CAF-only arm. CONCLUSION: The brief use of a phase II agent, regardless of its efficacy, followed by CAF resulted in response rates, toxicities, durations of response, and survival statistically equivalent to those seen with the use of CAF alone. These findings support the use of a new paradigm for the evaluation of phase II agents in the treatment of patients with metastatic breast cancer.

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