Drug intelligence / Profile preview

Cyclophosphamide, Docetaxel, and Exemestane Combination

Development stage
Unknown
Lead developer
Takeda
Modality
Nucleic Acid-Directed Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Oral, Intravenous
01

Overview

This is a combination therapy used primarily in breast cancer treatment. The provided text describes a phase II study where exemestane was given as initial neoadjuvant endocrine therapy, followed by either continued exemestane monotherapy or exemestane plus docetaxel-cyclophosphamide (TC) combination therapy in postmenopausal patients with primary invasive estrogen receptor-positive, HER2-negative breast cancer. In this regimen, patients initially received exemestane 25 mg/day for 12 weeks. After this initial period, treatment was tailored based on response. Non-responders to initial exemestane monotherapy received exemestane plus four cycles of TC (docetaxel 75 mg/m² and cyclophosphamide 600 mg/m² every 3 weeks). The clinical response rates at 24 weeks were 56% in the exemestane plus TC group. Grade ≥3 adverse events were reported in 53% of patients in the exemestane plus TC group. The docetaxel and cyclophosphamide (TC) component is a well-established chemotherapy regimen. Docetaxel works by damaging the structure that supports cancer cells, stopping them from growing and dividing. Cyclophosphamide attaches to and damages the DNA in cancer cells when they are in their resting phase, preventing further division. The recommended dose for the TC component is docetaxel 75 mg/m² in combination with cyclophosphamide 600 mg/m² given every 3 weeks. This dosing was established in phase I studies where the maximum tolerated dose was reached at docetaxel 85 mg/m² and cyclophosphamide 600 mg/m², with febrile neutropenia being the dose-limiting toxicity. This combination therapy represents a tailored approach to breast cancer treatment, where initial response to endocrine therapy guides subsequent treatment decisions, potentially improving outcomes while managing toxicity.

Other names
Exemestane plus TC
02

Targets

DNATUBB (Tubulin (alpha and beta subunits))CYP19A1 (Aromatase)

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