Breast NeoplasmPhase 2STOPNCT00638963
Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)
A Phase 2 study testing temozolomide in people with Breast Neoplasm and Brain Neoplasm, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Brain Neoplasm, Second Neoplasm
- What is being tested?
- temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2008to 30 Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
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.
Read the 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
- Being tested
- temozolomide
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Not described Receives: Drug: temozolomide |
| Observational | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Recurrence of Brain Metastases
The analysis could not be performed due to low enrollment.
Measured: 1 Year
Secondary outcomes (9)
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.
Measured: 24, 38, and 52 weeks
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.
Measured: 24, 38, and 52 weeks
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.
Measured: 24, 38, and 52 weeks
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.
Measured: 24,38, and 52 weeks
Number of Days on Temozolomide Treatment
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Measured: Baseline to 24 Weeks
Total Dose of Temozolomide Taken
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
Measured: Baseline to 24 Weeks
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.
Measured: Baseline to 24 Weeks
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.
Measured: Baseline to 24 Weeks
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.
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study start2 Oct 2008
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Why it stopped: Terminated due to poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638963
- Sponsor's protocol ID
- P05225
- Other IDs
- 2007-005491-14
- Acronym
- STOP
- Status last verified
- May 2017
- First submitted
- 10 Jan 2008
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
- ClinicalTrials.gov ID
- NCT00638963
- Acronym / sponsor ID
- STOP / P05225
- Conditions
- Breast Neoplasm, Brain Neoplasm, Second Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2008 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 22 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: temozolomide |
| Observational | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomideCapsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles | Drug | Temozolomide |
Primary outcome
Percent of Participants With Recurrence of Brain Metastases
Time frame: 1 Year
The analysis could not be performed due to low enrollment.
9 secondary outcomes
Number of Days With Progression-free Survival (PFS)
Time frame: 24, 38, and 52 weeks
Number of Days With Disease-free Survival (DFS)
Time frame: 24, 38, and 52 weeks
Number of Days With Distant Disease-free Survival (DDFS)
Time frame: 24, 38, and 52 weeks
Number of Days With Brain Recurrence-free Survival (BRFS)
Time frame: 24,38, and 52 weeks
Number of Days on Temozolomide Treatment
Time frame: Baseline to 24 Weeks
Total Dose of Temozolomide Taken
Time frame: Baseline to 24 Weeks
Number of Participants Who Had at Least One Dose Reduction During Treatment
Time frame: Baseline to 24 Weeks
Number of Participants Who Had at Least One Treatment Omission During Treatment
Time frame: Baseline to 24 Weeks
Number of Participants Who Completed the Third Cycle of Treatment
Time frame: Baseline to 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide in people with Breast Neoplasm and Brain Neoplasm, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Recurrence of Brain Metastases (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.