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

Primary Purpose

Breast Neoplasm, Brain Neoplasm, Second Neoplasm

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

temozolomide

About this trial

This is an interventional prevention trial for Breast Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Temozolomide

Observational

Arm Description

Outcomes

Primary Outcome Measures

Percent of Participants With Recurrence of Brain Metastases

The analysis could not be performed due to low enrollment.

Secondary Outcome Measures

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.

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.

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.

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.

Number of Days on Temozolomide Treatment

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Total Dose of Temozolomide Taken

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

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.

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.

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.

Full Information

NCT ID

NCT00638963

First Posted

January 10, 2008

Last Updated

May 18, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00638963

Brief Title

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

Acronym

STOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to poor accrual

Study Start Date

October 2, 2008 (Actual)

Primary Completion Date

June 30, 2010 (Actual)

Study Completion Date

June 30, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasm, Brain Neoplasm, Second Neoplasm

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temozolomide

Arm Type

Experimental

Arm Title

Observational

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

temozolomide

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent of Participants With Recurrence of Brain Metastases

Description

The analysis could not be performed due to low enrollment.

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Number of Days With Progression-free Survival (PFS)

Description

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.

Time Frame

24, 38, and 52 weeks

Title

Number of Days With Disease-free Survival (DFS)

Description

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.

Time Frame

24, 38, and 52 weeks

Title

Number of Days With Distant Disease-free Survival (DDFS)

Description

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.

Time Frame

24, 38, and 52 weeks

Title

Number of Days With Brain Recurrence-free Survival (BRFS)

Description

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.

Time Frame

24,38, and 52 weeks

Title

Number of Days on Temozolomide Treatment

Description

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Time Frame

Baseline to 24 Weeks

Title

Total Dose of Temozolomide Taken

Description

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Time Frame

Baseline to 24 Weeks

Title

Number of Participants Who Had at Least One Dose Reduction During Treatment

Description

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Time Frame

Baseline to 24 Weeks

Title

Number of Participants Who Had at Least One Treatment Omission During Treatment

Description

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Time Frame

Baseline to 24 Weeks

Title

Number of Participants Who Completed the Third Cycle of Treatment

Description

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Time Frame

Baseline to 24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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