PMID: 7579504Jan 1, 1995Paper

High dose toremifene for estrogen and progesterone receptor negative metastatic breast cancer: a phase II trial of the Cancer and Leukemia Group B (CALGB)

Breast Cancer Research and Treatment
J J PerryI C Henderson

Abstract

In pre-clinical and limited clinical studies, high doses ( > or = 200 mg/day) of the triphenylethylene derivative toremifene showed activity in estrogen receptor (ER) negative and ER-unknown metastatic breast cancer after progression on tamoxifen, and a mechanism of action independent of hormone receptor binding was speculated. The CALGB conducted a Phase II trial (CALGB 8945) to test the efficacy of high dose toremifene in a population of patients who had hormone receptor-negative, metastatic breast cancer with limited prior chemotherapy exposure, good performance status, and measurable disease. Twenty eligible patients received toremifene at a dose of 400 mg/day orally for 8 weeks. Toxicity was minimal. Nausea was reported by 20% of the patients, lightheadedness by 20%, weight loss by 20%, and hot flashes by 15%. There was no grade 3-4 toxicity. No objective responses were observed, and 5 of 6 patients with stable disease at 8 weeks developed progressive disease at 11 to 33 weeks. High dose toremifene (400 mg/day) is well-tolerated but imparts no detectable activity in hormone receptor-negative, metastatic breast cancer.

References

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Citations

Jun 1, 1997·Molecular Aspects of Medicine·V C Jordan, W J Gradishar
Jul 31, 2012·Wiley Interdisciplinary Reviews. Developmental Biology·Hector Macias, Lindsay Hinck

Related Concepts

Mammary Neoplasms, Human
Dose-Response Relationship, Drug
Neoplasm Metastasis
Estrogen Nuclear Receptor
Receptors, Progesterone
Toremifene, (E)-Isomer
Antineoplastic Agents, Hormonal

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