Clinical trial · Interventional
Carboplatin With or Without ZD4054 in Patients With Metastatic Breast Cancer
A Randomised Phase II Study of Carboplatin With or Without the Addition of the ETAR Inhibitor ZD4054 as Treatment for Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): New information on IMP affected the cost/benefit ratio
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| ZD4054 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (control): carboplatin + placebo
- description
- The control arm will consist of up to 6 cycles of carboplatin (AUC5 q21d for 6 cycles) iv over 30 minutes on day 1, plus placebo by mouth on days 1-21 of a 21 day cycle.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Arm B: carboplatin + ZD4054
- description
- The experimental arm will consist of up to 6 cycles of carboplatin (AUC5 q21d for 6 cycles) iv over 30 minutes on day 1, plus ZD4054 (10mg daily) od by mouth on days 1-21 of a 21 day cycle.
- interventionNames
- Drug: ZD4054
Primary outcomes (1)
- measure
- PFS (time to event)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available