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Active Trials: ATN-224
| Protocol ATN-224-009 (Breast Cancer) |
| Protocol
Title |
A Cancer Research UK Randomised Phase II Trial of ATN-224 (Copper Binding Agent) in Combination With Letrozole Versus Letrozole Alone in Post-menopausal Women With Recurrent, Oestrogen and/or Progesterone Receptor Positive Breast Cancer (PH2/053)
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| Objectives |
Primary
- Compare progression-free survival of ATN 224 in combination with letrozole versus letrozole alone, in post-menopausal women with recurrent, oestrogen and/or progesterone receptor positive breast cancer
- Establish the safety of ATN-224 in combination with letrozole in this patient population
Secondary
- Determine the response rate (overall and at 16 and 24 weeks), response duration, rate of stable disease for ≥16 and ≥24 weeks of patients treated with ATN-224 in combination with letrozole, and of patients treated with letrozole alone
- Determine the clinical benefit rate (complete and partial response, stable disease) at 16 and 24 weeks, for patients treated with ATN-224 in combination with letrozole, and for patients treated with letrozole alone
- Investigate further the time course of suppression of serum caeruloplasmin (Cp, surrogate for copper) using a 2 week loading dose (300 mg) of ATN-224, followed by 120 mg dose for 2 weeks
Investigate serum oestradiol and oestrone sulphate levels in patients treated with ATN-224 with letrozole and in patients treated with letrozole alone (to assess if ATN-224 interacts with the aromatase inhibition of letrozole) |
| Patient
Population |
Patients with histologically proven oestrogen and/or progesterone receptor positive breast cancer that has recurred after treatment with an anti-oestrogen |
| Study Status |
Not yet recruiting |
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