scholarly journals Randomized phase II clinical trial of pioglitazone plus chemotherapy versus chemotherapy alone in patients with metastatic breast cancer.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 83-83
Author(s):  
Reza Moghareabed ◽  
Simin Hemati ◽  
Ali Akhavan ◽  
Hamid Emami ◽  
Maryam Farghadani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Randomized Clinical Trial ◽  
Stable Disease ◽  
Chemotherapy Regimen ◽  
Metastatic Breast ◽  
Disease Status ◽  
Complete Response ◽  
Diabetic Woman

83 Background: Breast carcinoma is the second cause of mortality between female cancers and metastasis is the main contributing factor to the mortality in patients with breast cancer. Optimal management for visceral metastatic breast cancer (MBC) remains unknown. In this study we aimed to assess if adding pioglitazone to chemotherapy regimen can improve response in patients with MBC. Methods: This double-blind randomized clinical trial enrolled women 18 years or older with visceral MBC either previously treated with adjuvant therapy or currently are undergoing different lines of endocrine and chemotherapy regimens. The main objective of this study is to compare treatment efficacy in patients with visceral MBC taking chemotherapy plus Pioglitazone (n = 30) versus chemotherapy in addition to placebo (n = 30) over three months. The efficacy evaluated by change in radiologic response defined by the proportion of patients with stable or partial/complete radiologic response to those experienced disease progression based on Revised Recist Guideline ver (1.1). Results: Combination of pioglitazone and chemotherapy led to higher complete radiologic response (7.4% vs.0%) stable disease status (66·7% vs. 53·6%) and lower progression (22·2% vs. 35·7%) rates, however the differences were not statistically significant (P = 0.24). Clinical benefit rate (CBR, proportion of patients with complete response, partial response, or stable disease) was 77.8% in pioglitazone group vs. 64.3% in control group (p = 0.27). Subgroup analysis revealed higher efficacy but not statistically significant among diabetic woman, who had hormone-receptor–positive tumor. Furthermore, patients treated with Taxan +/-Carboplatin agents had significantly higher stable disease status, lower progression rate and higher complete response rate than the placebo group (P = 0·03). Conclusions: This is the first reported randomized clinical trial on the efficacy of pioglitazone in patients with visceral MBC which demonstrated safety and improvement of response in the subgroup of Taxan / Carboplatin chemotherapy regimen. These findings are in agreement with previous results of in vitro preclinical studies. Clinical trial information: IRCT20180124038493N1.

scholarly journals Factors Associated with Metastatic Breast Cancer in Patients Who Show Long-Term Stable Disease Status

2017 ◽  
Vol 5 (1) ◽  
pp. 1-7
Author(s):  
Young Hoon Noh ◽  
Yun Gyoung Kim ◽  
Ji Hyun Kim ◽  
Hyang Suk Choi ◽  
Seok Joon Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Stable Disease ◽  
Metastatic Breast ◽  
Disease Status ◽  
Factors Associated

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

1988 ◽  
Vol 6 (5) ◽  
pp. 825-831 ◽  
Author(s):  
J N Ingle ◽  
D I Twito ◽  
D J Schaid ◽  
S A Cullinan ◽  
J E Krook ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

Randomized trial of tamoxifen alone or combined with aminoglutethimide and hydrocortisone in women with metastatic breast cancer.

1986 ◽  
Vol 4 (6) ◽  
pp. 958-964 ◽  
Author(s):  
J N Ingle ◽  
S J Green ◽  
D L Ahmann ◽  
H J Long ◽  
J H Edmonson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Disease Progression ◽  
Randomized Clinical Trial ◽  
Metastatic Breast ◽  
Therapeutic Advantage

A randomized clinical trial was performed to compare the efficacy of tamoxifen (TAM) alone with that of TAM plus aminoglutethimide (AG) and hydrocortisone (HC). Patients failing TAM could receive AG and HC. Objective responses to therapy were seen in 21 of 49 TAM patients (43%) and 25 of 51 TAM, AG and HC patients (49%). Time to disease progression and survival distributions were not significantly different between the treatment arms. Toxicity was greater for patients treated with TAM, AG, and HC and the trial was discontinued early for this reason. Twenty-four patients received AG and HC after TAM therapy and three (12%) achieved a response. We conclude that the combination of TAM, AG, and HC is not recommended over TAM alone because toxicity appears to outweigh any potential therapeutic advantage.

A phase II clinical trial of ZD1839 (gefitinib) in combination with docetaxel as first-line treatment in patients with advanced breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1059-1059
Author(s):  
S. K. Dennison ◽  
S. A. Jacobs ◽  
J. Wilson ◽  
J. Seeger ◽  
T. Cescon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Stable Disease ◽  
Clinical Benefit ◽  
Metastatic Breast ◽  
Complete Response ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

1059 Background: We conducted a phase II multi-institutional trial of gefitinib and docetaxel as first-line treatment in patients with metastatic breast cancer. The primary objectives were to determine the clinical benefit rate (defined as the proportion of patients who experienced confirmed complete response or partial response or who had stable disease for at least 24 weeks) and the toxicity profile of the combination treatment. Methods: All patients had histologically confirmed breast cancer with metastatic disease. They may have received adjuvant chemotherapy, but no prior docetaxel or prior chemotherapy for metastatic disease. Patients received gefitinib 250 mg once daily and docetaxel 75 mg/m2 every 3 weeks, until tumor progression, toxicity or other reasons for discontinuation. Results: Between April 2003 and September 2004, 33 patients were enrolled at 11 participating institutions. Patients received a median of 5 cycles of treatment. The clinical benefit rate was 51.5% (95% CI: 33.5% - 69.2%). There was 1 confirmed complete response and 12 confirmed partial responses, and the overall objective response rate was 39.4% (95% CI: 22.9% - 57.9%). Four patients had stable disease for = 24 weeks. The median duration of clinical benefit was 10.9 months (95% CI: 6.0 - 17.6 months). The most common reason for study discontinuation was disease progression (16 patients), followed by toxicity (10 patients). Toxicities were mainly attributable to docetaxel, including = grade 3 neutropenia in 43% of patients. Conclusion: The combination of gefitinib and docetaxel is an active regimen in patients with previously untreated metastatic breast cancer. Further work is needed to determine which subset of patients with breast cancer will benefit from gefitinib. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document