Treatment of advanced breast cancer with tamoxifen: Evaluation of the dose-response relationship at two dose levels

1982 ◽  
Vol 2 (4) ◽  
pp. 395-400 ◽  
Author(s):  
Carsten Rose ◽  
Karen Theilade ◽  
Else Boesen ◽  
Marianne Salimtschik ◽  
Per Dombernowsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Response ◽  
Advanced Breast ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Dose Levels

Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: a prospective randomized trial.

1993 ◽  
Vol 11 (7) ◽  
pp. 1253-1263 ◽  
Author(s):  
C Focan ◽  
J M Andrien ◽  
M T Closon ◽  
M Dicato ◽  
P Driesschaert ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Response ◽  
Response Rate ◽  
Advanced Breast ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
First Line ◽  
Group A ◽  
Group B

PURPOSE We compared prospectively the antitumor efficacy of two combination chemotherapy regimens with two different dose levels of epirubicin as first-line treatment for advanced breast cancer. PATIENTS AND METHODS One hundred forty-one fully assessable patients were randomized to receive either our intensified schedule (group A, n = 71) of epirubicin 50 mg/m2 on days 1 and 8 (every 3 weeks), or a non-intensified program (group B, n = 70) in which epirubicin was only administered on day 1. Both groups also received fluorouracil (5 FU) and cyclophosphamide 500 mg/m2 on day 1 of each course. RESULTS A statistically significant difference in response rate was observed (69% in group A v 41% in group B, P < .001) for both locally advanced (LA) and recurrent metastatic (RM) disease. Response duration (22 v 14 months, P < .01) and time to progression (TTP; 19 v 8 months, P < .02) were also significantly improved. Overall survival was similar in both groups. However, univariate and/or multivariate analyses showed a meaningful relationship between type of treatment allocated, dose-intensity (DI) of epirubicin, and response rate, as well as between TTP and survival. Ultimately, TTP and survival were also influenced by further treatment modalities, namely, hormonotherapy and chemotherapy. CONCLUSION This study validates prospectively the concept of a dose-response relationship for an anthracycline-based chemotherapy in previously untreated advanced breast cancer.

Dose-response effect to epirubicin (EPI) in patients (PTS) with advanced breast cancer (ABC)

1994 ◽  
Vol 30 ◽  
pp. S26
Author(s):  
P. Vici ◽  
F. Conti ◽  
L. Di Lauro ◽  
I. Venturo ◽  
G. Paoletti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Dose Response ◽  
Advanced Breast ◽  
Response Effect ◽  
Dose Response Effect

Safety, Pharmacokinetics, and Preliminary Activity of CDK4/6 Inhibitor FCN-437c in Chinese Female Patients with HR+HER2- Advanced Breast Cancer (ABC) From Phase Ia Study

2021 ◽  
Author(s):  
Jian Zhang ◽  
Xiaojia Wang ◽  
Xian Wang ◽  
Aimin Hui ◽  
Zhuli Wu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Objective Response ◽  
Human Study ◽  
Standard Of Care ◽  
Maximum Tolerated Dose ◽  
Advanced Breast ◽  
Female Patients ◽  
Best Response ◽  
Dose Levels

Abstract Purpose: This is a phase Ia, first-in-human study aiming to assess the safety, maximum tolerated dose (MTD), pharmacokinetic (PK) and anti-tumor activity of FCN-437c, CDK4/6 inhibitor, as monotherapy in patients with HR+HER2- ABC (advanced breast cancer) who failed standard of care. Methods: Regular 3+3 dose escalation design was utilized with starting dose of 50 mg per day for 3 weeks on -1 week off treatment in a 28-day cycle. Seventeen eligible female patients with HR+HER2- ABC were enrolled at different dose levels: 50 mg (n = 3), 100 mg (n = 3), 200 mg (n = 3), 300 mg (n = 6) and 450 mg (n = 2). Results: Two patients in the 450 mg dose group experienced DLT of grade 4 thrombocytopenia and neutropenia respectively, and no DLT was observed in other dose levels. The most frequently reported TEAEs was hematological, including leukopenia (94.1%), neutropenia (88.2%), anemia (64.7%) and thrombocytopenia (47.1%). Major grade 3-4 TEAEs were neutropenia and leukopenia, occurring in 11 (64.7%) and 8 (47.1%) patients, respectively. The exposure increased almost in proportion to given dose ranging from 50 to 200 mg. At multiple dose levels from 200 to 450 mg, there appeared to be a trend of saturation. MTD was determined to be 300 mg. Of 15 measurable patients, nine (60.0%) had the best response of stable disease and no objective response was observed. Conclusions: FCN-437c has established an acceptable safety profile with no unexpected signals compared to other CDK4/6 inhibitors. (NCT04488107, Jul 13th 2020)

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