Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-128-08
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

• Provision of fully informed consent before carrying out any specific study procedure.
• Patients must be> 18 years old.
• Female patients with histologically or cytologically diagnosed triple negative metastatic breast cancer.
• Pass II only - At least one lesion, not irradiated within 12 weeks of the first administration of the study treatment, that can be measured exactly as> 10 mm in the longest diameter with spiral computed tomography (CT) or as> 20 mm with conventional techniques in accordance with RECIST (CT, conventional MRl) and that is suitable for exact repeated measurements.
• Patients must have normal function of the organs and bone marrow measured within 7 days prior to the administration of the study treatment.
• ECOG <2 functional status for breast (see Appendix F)
• Patients must have a life expectancy> 16 weeks.
• Evidence of potentially non-fertile status: negative pregnancy test in urine or serum within 7 days of the study treatment for potentially fertile women, or postmenopausal status.
• The patient wants and can comply with the protocol throughout the study including undergoing treatment, and scheduled exams and visits.
• A sample of tumor fixed in formalin and embedded in paraffin from primary or recurrent cancer must be available for a central test. If an archive tumor sample is not available, the patient will not be eligible for the study.

Exclusion Criteria

• Any previous treatment with a PARP inhibitor, including AZD2281, in the past or any treatment with paclitaxel within the past 12 months.
• Patients with a second primary cancer, except: properly treated non-melanoma skin cancer, curatively treated cervical cancer in situ or other curatively treated solid tumors without evidence of disease for> 5 years.
• Patients receiving any chemotherapy, radiation therapy (except for palliative reasons), within 2 weeks of the last dose before entering the study (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 provided that these agents have been started at least 4 weeks before enrollment.
• Patients with symptomatic uncontrolled brain metastases. A sweep is not required to confirm the absence of brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these agents have been started at least 4 weeks before enrollment.
• More than one previous chemotherapy for advanced disease and / or extensive irradiation that leads to bone marrow deficiency. Extensive radiation therapy would be one that affects 30% of the bone marrow, for example, the entire pelvis or half of the spine.
• Major surgery within 4 weeks of starting the study and patients must have recovered from any effect of any major surgery.
• Pre-existing peripheral neuropathy> grade 1.
• Patients considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection.
• Patients who cannot swallow the orally administered drug and patients with gastrointestinal disorders that are likely to interfere with the absorption of the study drug (for example, partial intestinal obstruction or malabsorption).
• Patients requiring treatment with CYP3A4 inhibitors or inducers
• Patients requiring treatment with CYP2C8 inhibitors or inducers
• Women who are pregnant or breastfeeding.
• Immunocompromised patients, for example, known to be serologically positive for the human immunodeficiency virus (HIV).
• Patients with known liver disease (ie Hepatitis B or C).
• Persistent toxicities (grade 2 or higher) of any cause, except for alopecia.
• Participation in the planning and / or execution of the study (applies to both AstraZeneca staff and staff at the study site).
• Prior randomization for treatment in the present study.
• Treatment with any product under investigation during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
• Patient with a history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil).
• Patients with known hypersensitivity to AZD228I or any of the excipients of the product.
• Patients who currently experience seizures or who were being treated only with seizure antiepileptic drugs (the use of antiepileptic drugs is allowed to control pain in patients who do not suffer from seizures unless the drug is excluded due to CYP3A4-phenytoin induction, carbamazepine, phenobarbitone, see Section 6.4.1).

Study & Design

• Study Type: Interventional
• Study Design: Not specified