Breast CancerPhase 2NCT00106002

Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

A Phase 2 study testing pemetrexed in people with Breast Cancer and Breast Neoplasms, Male, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
What is being tested?: pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Apr 2005to Dec 2007
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

Must have been diagnosed with either advanced or metastatic breast cancer.
Chemotherapy has not been given for advanced or metastatic breast cancer.
The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
Able to carry out work of a light nature (for example, light housework, office work).
Must be at least 18 years old.

Who cannot join

Have received prior bone marrow or peripheral stem cell transplantation.
Have received prior chemotherapy for metastatic breast cancer.
Are currently pregnant or breast-feeding.
Have an active infection that your doctor decides will affect your safety.
Are unable to take folic acid or vitamin B12.

Trial locations and contacts

1 site in 1 country.

United States1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, 75204

Other trials in United States

About this study

Official title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Conditions: Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
Being tested: pemetrexed
Medical subject headings: Breast Neoplasms, Breast Neoplasms, Male, Carcinoma, Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pemetrexedDrug
Also called LY231514, Alimta
600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Study groups in NCT00106002
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Measured: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Secondary outcomes (4)

Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
Measured: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
Duration of Tumor Response
Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
Measured: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Progression-Free Survival Time
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Measured: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Overall Survival Time
Defined as the time from date of first dose to time of death due to any cause.
Measured: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Dec 2007

First posted21 Mar 2005 (estimated)
Study startApr 2005
Primary completionDec 2007
Study completionDec 2007

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 CancerStudies 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)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106002
Sponsor's protocol ID: 9028
Other IDs: H3E-US-S045
Status last verified: Apr 2009
First submitted: 18 Mar 2005
Last updated: 1 Jun 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00106002
Acronym / sponsor ID: 9028
Conditions: Breast Cancer, Breast Neoplasms, Male, Carcinoma, Ductal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 21 Mar 2005 (estimated)
Results: Posted 1 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: pemetrexed

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must have been diagnosed with either advanced or metastatic breast cancer.
Chemotherapy has not been given for advanced or metastatic breast cancer.
The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
Able to carry out work of a light nature (for example, light housework, office work).
Must be at least 18 years old.

Key exclusion criteria (5 listed)

Have received prior bone marrow or peripheral stem cell transplantation.
Have received prior chemotherapy for metastatic breast cancer.
Are currently pregnant or breast-feeding.
Have an active infection that your doctor decides will affect your safety.
Are unable to take folic acid or vitamin B12.

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
pemetrexedAlso: LY231514, Alimta600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression	Drug	A

Primary outcome

Overall Tumor Response
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

4 secondary outcomes

Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
Time frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
Duration of Tumor Response
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Progression-Free Survival Time
Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Overall Survival Time
Time frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up

Results and safety

Results posted to the registry on 1 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pemetrexed	37	35

Primary outcome: Overall Tumor Response

Time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression. Number. Unit: participants

Measure	Pemetrexed n = 35
Complete Response	1
Partial Response	8
Stable Disease	14
Progressive Disease	9
Best Response Not Evaluable	3

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed	14 of ?	34 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Breast Cancer

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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 in people with Breast Cancer and Breast Neoplasms, Male, 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 1 Jun 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 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?

Yes. Results are posted in the registry (first posted 1 Jun 2009). 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?

Overall Tumor Response (time frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression). 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 NCT00106002.

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 1 Jun 2009.