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Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)

Phase 2
18 Years
Not Enrolling
Breast Neoplasm, Brain Neoplasm, Second Neoplasm

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Trial Information

Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)

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).

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Percent of Participants With Recurrence of Brain Metastases

Outcome Description:

The analysis could not be performed due to low enrollment.

Outcome Time Frame:

1 Year

Safety Issue:



Italy: Ministry of Health

Study ID:




Start Date:

October 2008

Completion Date:

June 2010

Related Keywords:

  • Breast Neoplasm
  • Brain Neoplasm
  • Second Neoplasm
  • Brain Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Recurrence
  • Neoplasms, Second Primary