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

Breast Neoplasm Clinical Trial

— STOP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638963
• Other study ID #: P05225
• Secondary ID: 2007-005491-14
• Status: Terminated
• Phase: Phase 2
• First received: January 10, 2008
• Last updated: January 19, 2015
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Recurrence of Brain Metastases	The analysis could not be performed due to low enrollment.	1 Year	No
Secondary	Number of Days With Progression-free Survival (PFS)	PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.; The analysis could not be performed due to low enrollment.	24, 38, and 52 weeks	No
Secondary	Number of Days With Disease-free Survival (DFS)	DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).; The analysis could not be performed due to low enrollment.	24, 38, and 52 weeks	No
Secondary	Number of Days With Distant Disease-free Survival (DDFS)	DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).; The analysis could not be performed due to low enrollment.	24, 38, and 52 weeks	No
Secondary	Number of Days With Brain Recurrence-free Survival (BRFS)	BRFS was defined as the time interval from randomization to the appearance of brain metastases.; The analysis could not be performed due to low enrollment.	24,38, and 52 weeks	No
Secondary	Number of Days on Temozolomide Treatment	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.	Baseline to 24 Weeks	No
Secondary	Total Dose of Temozolomide Taken	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.	Baseline to 24 Weeks	No
Secondary	Number of Participants Who Had at Least One Dose Reduction During Treatment	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.	Baseline to 24 Weeks	No
Secondary	Number of Participants Who Had at Least One Treatment Omission During Treatment	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.	Baseline to 24 Weeks	No
Secondary	Number of Participants Who Completed the Third Cycle of Treatment	This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.	Baseline to 24 Weeks	No