Breast NeoplasmsPhase 2NCT00034489
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
A Phase 2 study testing pemetrexed and gemcitabine in people with Breast Neoplasms, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- pemetrexed and gemcitabine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- confirmed diagnosis of breast cancer
- measurable disease
- received prior anthracycline and taxane
- life expectancy > 3 months
- acceptable lab results
Who cannot join
- >3 prior regimens
- prior treatment with protocol drugs
- prior (pelvic) radiation
- active CNS metastasis
- inability to take oral vitamins
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.
Read the detailed description
Gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection. Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.
- Conditions
- Breast Neoplasms
- Being tested
- pemetrexed, gemcitabine
- Keywords
- metastatic breast cancer, combination therapy, Alimta
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
gemcitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034489
- Sponsor's protocol ID
- 2245
- Other IDs
- H3E-MC-JMCF
- Status last verified
- Jul 2006
- First submitted
- 29 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT00034489
- Acronym / sponsor ID
- 2245
- Conditions
- Breast Neoplasms
- Keywords
- metastatic breast cancer, combination therapy, Alimta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 30 Apr 2002 (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.
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.
Detailed description
Gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection. Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.
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 (5 listed)
- confirmed diagnosis of breast cancer
- measurable disease
- received prior anthracycline and taxane
- life expectancy > 3 months
- acceptable lab results
Key exclusion criteria (5 listed)
- >3 prior regimens
- prior treatment with protocol drugs
- prior (pelvic) radiation
- active CNS metastasis
- inability to take oral vitamins
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 |
|---|---|---|
| pemetrexed | Drug | – |
| gemcitabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2006.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
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 pemetrexed and gemcitabine in people with Breast Neoplasms, run by Eli Lilly and Company at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jul 2006. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Jul 2006.