Metastatic breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
1. Stage 1
Patients will receive carboplatin (AUC4 or AUC5 q21d as below) + ZD4054 (10mg daily). Dose limiting toxicity (DLT) and safety assessments will be performed during cycle 1. Patients may rec
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) (time to event) based on Response Evaluation Criteria in Solid Tumours (RECIST v1.1). Time from enrolment to any progression and/or death. Those progression-free and alive will be censored at time of last follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety, tolerability (side effects) and feasibility of use (number of participants requiring dose delays or reductions and/or treatment withdrawal). 2. Objective response rate as assessed by RECIST v1.1. | — |
Countries
United Kingdom
Outcome results
None listed