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. - PLANET

• Conditions: Metastatic Breast Cancer

• Registration Number: EUCTR2010-018837-23-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The main inclusion criteria for this trial are as follows:
1) Patients aged over 18 years
2) 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.
3) No more than 2 prior lines of chemotherapy treatment for metastatic breast cancer.
4) Life expectancy greater than 3 months
5) Patients must have previously received or be ineligible for a taxane
6) Informed consent
7) Adequate bone marrow and hepatic function.
8) 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;
9) Total bilirubin < 1.5 x upper normal limit;
10) AST and ALT = 2.5 x upper normal limit (or = 5x UNL in the presence of liver metastases);
11) Adequate renal function.
12) GFR =60mls/min calculated using Wright Formula or measured by EDTA plasma clearance (See 10.1 and Appendix 3).
13) 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.
14) ECOG performance status =2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The main exclusion criteria for this trial are as follows:
1) Previous treatment with platinum based chemotherapy.
2) Previous treatment with ZD4054.
3) Co-existing active infection or serious concurrent medical condition.
4) Significant cardiovascular disease defined as:
•history of congestive heart failure requiring therapy (NHYA grade 2 or higher);
•history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry;
•presence of severe valvular heart disease;
•presence of a ventricular arrhythmia requiring treatment.
5) 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.
6) Known brain or leptomeningeal metastases.
7) Gastrointestinal disorders likely to interfere with absorption of the study drug.
8) Patients known to be serologically positive for Hepatitis B or Hepatitis C (mandatory testing not required).
9) Immunocompromised patients e.g. Patients who are known to be serologically positive for human immunodeficiency virus (HIV) (mandatory testing not required).
10) Participation in any other interventional clinical study within the previous 4 weeks or during the course of this study.
11) Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
12) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons.
13) Concomitant administration of potent CYP3A inhibitors, specifically: Protease inhibitors (atanazavir, indinavir, nelfinavir, ritonavir, saquinavir), Macrolide antibiotics (clarithromycin, telithromycin), Azole antifungals (ketoconazole, itraconazole, voriconazole), nefazodone.
14) Concomitant administration of CYP3A inducers, specifically: rifampicin, rifapentine, rifabutin, phenytoin, carbamazepine, phenobarbitol, St John’s Wort. See section 8.5.1.
15) Women who are breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this trial is to establish whether the addition of ZD4054 to carboplatin is an active regimen in metastatic breast cancer in terms of progression-free survival.;Secondary Objective: The secondary objectives of this trial are to determine if the combination of ZD4054 and carboplatin is safe, feasible and tolerable in this patient population and to collect blood and tissue samples from this patient population to facilitate future translational research.;Primary end point(s): Progression-Free Survival(PFS). Progression is defined according to RECIST 1.1.