Breast CancerPhase 2NCT00875355
Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
A Phase 2 study testing temozolomide and radiation therapy in people with Breast Cancer and Metastatic Cancer, run by Institut Curie at 1 site in France.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Cancer
- What is being tested?
- temozolomide and radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Unresectable disease or patient refused surgery
- Must have brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No carcinomatous meningitis
- No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment
- No contraindications to treatment with temozolomide
- No psychological, familial, social, or geographic situations that preclude clinical follow up
- No patient deprived of liberty or under guardianship
PRIOR CONCURRENT THERAPY:
- No prior brain radiotherapy
- At least 10 days since prior chemotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Curie Hopital
Paris, 75248
Youlia Kirova, 33-44-32-4000
About this study
Official title: Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.
Secondary
- Evaluate the tolerability.
- Compare the duration of response.
- Compare local progression-free survival.
- Compare overall survival.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.
- Conditions
- Breast Cancer, Metastatic Cancer
- Being tested
- temozolomide, radiation therapy
- Keywords
- tumors metastatic to brain, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Given orally
radiation therapyRadiation
Patients undergo radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. Receives: Radiation: radiation therapy |
| Arm II | Experimental | Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks. Receives: Drug: temozolomide; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response at 6 weeks as assessed by MRI and/or scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Investigators
- Youlia Kirova, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875355
- Sponsor's protocol ID
- CDR0000633496
- Other IDs
- CLCC-IC-RT-TEMODAL, CLCC-IC-2007-01, INCA-RECF0630, EUDRACT-2007-002531-83, SCHER-CLCC-IC-RT-TEMODAL
- Status last verified
- Jul 2009
- First submitted
- 2 Apr 2009
- Last updated
- 26 Aug 2009
- Results posted
- No
Publications
Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.
PubMed 25355723
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT00875355
- Acronym / sponsor ID
- CDR0000633496
- Conditions
- Breast Cancer, Metastatic Cancer
- Keywords
- tumors metastatic to brain, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (estimated)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.
Secondary
- Evaluate the tolerability.
- Compare the duration of response.
- Compare local progression-free survival.
- Compare overall survival.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
- Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: radiation therapyPatients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. |
| Arm II | Experimental | Drug: temozolomide, Radiation: radiation therapyPatients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| temozolomideGiven orally | Drug | Arm II |
| radiation therapyPatients undergo radiotherapy | Radiation | Arm I, Arm II |
Primary outcome
Response at 6 weeks as assessed by MRI and/or scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
- Derived from this study: PubMed 25355723Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.
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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.
Youlia Kirova principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide and radiation therapy in people with Breast Cancer and Metastatic Cancer, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response at 6 weeks as assessed by MRI and/or scan. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875355, which also lists 1 linked publication.
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 26 Aug 2009.