Carboplatin with or without ZD4054 in patients with metastatic breast cancer

Completed

• Conditions: Metastatic breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN73466214
• Lead Sponsor: Cardiff University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

1. Patients aged = 18
2. Histological or cytological diagnosis of breast cancer
3. Metastatic disease
4. No more than 2 prior lines of chemotherapy treatment for metastatic breast cancer
5. Life expectancy greater than 3 months
6. Patients must have previously received or be ineligible for a taxane
7. Informed consent
8. Adequate haematological, renal and hepatic function.
9. At least one measurable lesion on Computed Tomography (CT) scanning

Exclusion Criteria

1. Previous treatment with platinum based chemotherapy
2. Known brain or leptomeningeal metastases
3. Any co-existing medical condition 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
4. Concomitant medication unsuitable for combination with trial medication
5. Concomitant administration of potent CYP3A inhibitors, specifically:
5.1. Protease inhibitors (atanazavir, indinavir, nelfinavir, ritonavir, saquinavir)
5.2. Macrolide antibiotics (clarithromycin, telithromycin)
5.3. Azole antifungals (ketoconazole, itraconazole, voriconazole)
5.4. Nefazodone

Study & Design

• Study Type: Interventional
• Study Design: Not specified