Breast CancerPhase 2NCT00193102
Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
A Phase 2 study testing Thalidomide and Capecitabine in people with Breast Cancer, run by SCRI Development Innovations, LLC.
Trial summary
The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Thalidomide and Capecitabine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Jun 2010
- 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
Who may be able to join
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- Measurable or evaluable disease
- Females > 18 years
- Able to perform activities of daily living with minimal assistance
- Life expectancy > 3 months
- Adequate bone marrow, liver and kidney function
- All patients must give written informed consent in order to participate.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Women who are pregnant or lactating.
- Received more than 3 prior chemotherapy regimens in the metastatic setting.
- Received continuous infusion 5-fluorouracil lasting > 120 hours.
- Received thalidomide or capecitabine as their last prior regimen.
- Preexisting moderate to severe neuropathy
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.
Read the detailed description
Upon determination of eligibility, patients will be receive:
Thalidomide + Capecitebine
- Conditions
- Breast Cancer
- Being tested
- Thalidomide, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Thalidomide
CapecitabineDrug
Capecitabine
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionFeb 2005
- Study completionJun 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Howard Burris, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193102
- Sponsor's protocol ID
- SCRI BRE 60
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2011
- Results posted
- No
Publications
Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/07357901003631049.
PubMed 20210519
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00193102
- Acronym / sponsor ID
- SCRI BRE 60
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Apr 2001
- Primary completion
- Feb 2005 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Sep 2005 (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.
The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.
Detailed description
Upon determination of eligibility, patients will be receive:
Thalidomide + Capecitebine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metastatic breast cancer confirmed by biopsy
- Measurable or evaluable disease
- Females > 18 years
- Able to perform activities of daily living with minimal assistance
- Life expectancy > 3 months
Key exclusion criteria (7 listed)
- Women who are pregnant or lactating.
- Received more than 3 prior chemotherapy regimens in the metastatic setting.
- Received continuous infusion 5-fluorouracil lasting > 120 hours.
- Received thalidomide or capecitabine as their last prior regimen.
- Preexisting moderate to severe neuropathy
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 |
|---|---|---|
| ThalidomideThalidomide | Drug | – |
| CapecitabineCapecitabine | Drug | – |
Primary outcome
Overall response rate
Time frame: 18 Months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Results publication: PubMed 20210519Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/07357901003631049.
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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.
Howard Burris, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide and Capecitabine in people with Breast Cancer, run by SCRI Development Innovations, 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 8 inclusion and 7 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 3 May 2011. 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?
The study was stopped early. Results are not available in the source record.
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?
Overall response rate (time frame: 18 Months). 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 NCT00193102, 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 3 May 2011.