A Phase I/II randomised, double-blind, multi-centre study to assess the efficacy of AZD2281 when given in combination with paclitaxel in the 1st or 2nd line treatment of patients with metastatic Triple Negative Breast Cancer

AstraZeneca AB0 sites260 target enrollmentJuly 14, 2008

ConditionsMetastatic Triple Negative Breast Cancer MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Triple Negative Breast Cancer
Sponsor: AstraZeneca AB
Enrollment: 260
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 14, 2008

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1\.Provision of fully informed consent prior to any study specific procedures
•2\.Patients must be \> 18 years of age
•3\.Female patients with histologically or cytologically diagnosed metastatic triple\-negative breast cancer
•\-Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast defined as:
•§For ER, PR status: Allred\<3 or ER, PR IHC 0 and
•§For HER2 status: IHC 0 or 1\+ or FISH negative; if IHC 2\+, need negative FISH confirmation.
•4\.Phase II only \- At least one lesion, not irradiated within 12 weeks of the first administration of study treatment, that can be accurately measured as ³ 10 mm in the longest diameter with spiral computed tomography (CT) scan or as ³ 20 mm with conventional techniques according to RECIST (Conventional CT, MRI) and which is suitable for accurate repeated measurements.
•5\.Patients must have normal organ and bone marrow function measured within 7 days prior to administration of study treatment as defined below:
•\-Haemoglobin \= 9\.0 g/dL
•\-Absolute neutrophil count (ANC) \= 1500 x 106/L

Exclusion Criteria

•1\.Previous treatment with AZD2281
•2\.Patients with second primary cancer, except: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \= 5 years.
•3\.Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to enrolment.
•4\.Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to enrolment.
•5\.More than one prior chemotherapy for advanced disease and/or extensive irradiation leading to bone marrow deficiency. Extensive radiotherapy would be that involving 30% of the bone marrow e.g. whole pelvis or half spine.
•6\.Major surgery within 4 weeks of starting the study and patients must have recovered from any effects of any major surgery.
•7\.Pre\-existing peripheral neuropathy \> grade 1\.
•8\.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non\-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months), myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
•9\.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication (e.g. partial bowel obstruction or malabsorption)
•10\.Patients requiring treatment with inhibitors or inducers of CYP3A4 (see Section 6\.4\.1 for guidelines and wash out periods).