Carboplatin With or Without ZD4054 in Patients With Metastatic Breast Cancer

• Status: Withdrawn
• Trial end date: 2011-08-16
• Target enrollment: 0
• Participant gender: All

Summary

In this "randomised Phase II trial" all patients will receive carboplatin, with half randomly selected to receive ZD4054. The other half to also receive a dummy pill or placebo, this is so that we can accurately assess how much extra benefit ZD4054 may give. The trial will recruit 132 patients with metastatic breast cancer from across the UK and assess whether adding ZD4054 to carboplatin delays progression of their disease. It will also show whether the side effects of adding ZD4054 to carboplatin chemotherapy are acceptable.

Because ZD4054 has not previously been given with carboplatin to this population, in Stage 1 of the study 6 patients will receive ZD4054 with carboplatin. If there are no untoward side effects with carboplatin and ZD4054 then the trial will proceed to Stage 2 and a further 126 patients will be randomised to receive carboplatin with either ZD4054 or the placebo; neither the patient nor their doctor will know whether she is receiving ZD4054 or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiff University
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Patients aged over 18

• Histological or cytological diagnosis of metastatic breast cancer, or previous histological diagnosis of breast cancer and evidence of metastatic or locally advanced disease unsuitable for local therapy

• No more than 2 prior lines of chemotherapy treatment for metastatic breast cancer

• Life expectancy greater than 12 weeks

• Patients must have previously received or be ineligible for a taxane

• Informed written consent

• Adequate bone marrow and hepatic function

• Haemoglobin ≥ 9.0 g/dl (if no prior transfusion or transfusion more than 4 weeks previously) or ≥ 10.0 g/dl (transfusion within last 4 weeks), absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥100 x 109/L

• Total bilirubin < 1.5 x upper normal limit

• AST and ALT ≤ 2.5 x upper normal limit (or ≤ 5x UNL in the presence of liver metastases)

• Adequate renal function

• GFR ≥ 60 mls/min calculated using Wright Formula or measured by EDTA plasma clearance At least one measurable lesion on CT scanning. Disease measurable by other RECIST v1.1 compatible imaging (e.g. MRI, CXR) or clinically measurable will be allowed as long as the same assessment method is used throughout the trial

• ECOG performance status ≤ 2

Exclusion Criteria:

• Previous treatment with platinum based chemotherapy

• Known brain or leptomeningeal metastases

• Any co-existing medical conditions that, in the Investigator's judgement, may substantially increase the risk associated with the patient's participation in the study or potentially hamper compliance with the study protocol and follow-up schedule

• Concomitant medication unsuitable for combination with trial medication

• Concomitant administration of potent CYP3A inhibitors, specifically: Protease inhibitors (atanazavir, indinavir, nelfinavir, ritonavir, saquinavir), Macrolide antibiotics (clarithromycin, telithromycin), Azole antifungals (ketoconazole, itraconazole, voriconazole), nefazodone