Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

NCT ID: NCT00638963

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-02
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Detailed Description

Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).

Conditions

Breast Neoplasm; Brain Neoplasm; Second Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Temozolomide

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Observational

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

temozolomide

Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of metastatic breast cancer.
• Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
• No clinical sign of brain progression.
• At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Life expectancy ≥3 months.
• Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
• Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
• AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
• Serum creatine <1.5 x ULN.
• Effective contraception if the risk of conception exists.

Exclusion Criteria

• Concurrent chronic systemic immune therapy not indicated in the study protocol.
• Any investigational agent(s) within 4 weeks prior to entry.
• Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
• Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
• Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
• Known drug abuse/alcohol abuse.
• Legal incapacity or limited legal capacity.
• Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
• Women who are pregnant or breastfeeding.
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2007-005491-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05225

Identifier Type: -

Identifier Source: org_study_id