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[Clinical evaluation of CGS16949A in advanced or recurrent breast cancer--a multi-institutional late phase II clinical trial].

Abstract
A multi-institutional late-phase II clinical trial of CGS 16949A was conducted at the dose of 1 mg twice daily in postmenopausal patients with advanced or recurrent breast cancer. Seventy patients entered into the study; 65 were eligible and 53 were complete cases. There were 3 CR, 11 PR, 10 long-NC, 14 NC and 25 PD with an overall response rate of 22.2% in 63 evaluable cases. The median period of overall duration of responses was 327.5 days. There were 22 cases that drug was found useful or better, and global usefulness rate was 33.8%. Forty six (76.7%) of patients experienced no side effects in this therapy. Grade 2 toxicities included anorexia (1 pt.), feeling of distension of abdomen (1 pt.), vomiting (1 pt.), fatigue (1 pt.), and only one patient experienced Grade 3 toxicity (anorexia). Grade 2 laboratory abnormalities were confirmed in two patients; one with elevated gamma-GTP and another with elevated LDH, and both were in the absence of liver metastasis. From these results, it is concluded that CGS16949A seemed to be a useful hormonal agent in the treatment of postmenopausal breast cancer.
AuthorsH Aoyama, K Asaishi, R Abe, T Kajiwara, K Enomoto, M Yoshida, Y Ohasi, T Tominaga, O Abe
JournalGan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 21 Issue 4 Pg. 477-84 (Mar 1994) ISSN: 0385-0684 [Print] Japan
PMID8129388 (Publication Type: Clinical Trial, Clinical Trial, Phase II, English Abstract, Journal Article, Multicenter Study)
Chemical References
  • Fadrozole
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Anorexia (chemically induced)
  • Breast Neoplasms (drug therapy, pathology)
  • Drug Administration Schedule
  • Fadrozole (administration & dosage, adverse effects)
  • Female
  • Humans
  • Middle Aged
  • Nausea (chemically induced)
  • Neoplasm Recurrence, Local (drug therapy)
  • Postmenopause

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