Breast CancerPhase 2NCT00149214
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
A Phase 2 study testing pemetrexed, cyclophosphamide and doxorubicin in people with Breast Cancer, run by Eli Lilly and Company at 11 sites in 4 countries.
Trial summary
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pemetrexed, cyclophosphamide and doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Sep 2005to Mar 2011
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
- Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
- Adequate organ function (bone marrow, hepatic, renal, cardiac).
Who cannot join
- Prior anthracyclines as part of prior anticancer therapy.
- Concurrent antitumor therapy.
- Second primary malignancy.
- Serious concomitant systemic disorder.
- Pre-existing sensorial or motor neuropathy
- Grade 1.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Germany4 sites
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.
Baden-Baden, 76532
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.
Berlin, 10967
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.
Hamburg, 20357
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.
Heidelberg, D-69115
Spain3 sites
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.
Jaén, 23007
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.
Sabadell, 08208
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.
Valencia, 46010
Italy2 sites
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.
Cremona, 26100
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.
Rozzano, 20089
Russia2 sites
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.
Moscow, 129128
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.
Saint Petersburg, 197022
About this study
Official title: A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).
- Conditions
- Breast Cancer
- Being tested
- pemetrexed, cyclophosphamide, doxorubicin, docetaxel
- 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
Also called LY231514, Alimta
500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
cyclophosphamideDrug
600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
doxorubicinDrug
60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
docetaxelDrug
100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
| Study group | Role | What they receive |
|---|---|---|
| A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel | Experimental | Not described Receives: Drug: pemetrexed; Drug: doxorubicin; Drug: docetaxel |
| B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | Active comparator | Not described Receives: Drug: cyclophosphamide; Drug: doxorubicin; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Pathological Complete Response
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Measured: surgery after eight 21-day cycles of chemotherapy
Secondary outcomes (4)
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.
Measured: Cycles 1-4 (21-day cycles)
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.
Measured: Cycles 5-8 (21-day cycles)
Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
Measured: surgery after eight 21-day cycles of chemotherapy
Disease-free Survival
Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.
Measured: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2008
- Study completionMar 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST), Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149214
- Sponsor's protocol ID
- 7113
- Other IDs
- H3E-MC-S080
- Status last verified
- Mar 2012
- First submitted
- 2 Sep 2005
- Last updated
- 21 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.
PubMed 20732932
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00149214
- Acronym / sponsor ID
- 7113
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 13 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel | Experimental | Drug: pemetrexed, Drug: doxorubicin, Drug: docetaxel |
| B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel | Active comparator | Drug: cyclophosphamide, Drug: doxorubicin, Drug: docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
- Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
- Adequate organ function (bone marrow, hepatic, renal, cardiac).
Key exclusion criteria (6 listed)
- Prior anthracyclines as part of prior anticancer therapy.
- Concurrent antitumor therapy.
- Second primary malignancy.
- Serious concomitant systemic disorder.
- Pre-existing sensorial or motor 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 |
|---|---|---|
| pemetrexedAlso: LY231514, Alimta500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) | Drug | A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel |
| cyclophosphamide600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4) | Drug | B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel |
| doxorubicin60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) | Drug | A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel, B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel |
| docetaxel100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) | Drug | A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel, B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel |
Primary outcome
Number of Participants With a Pathological Complete Response
Time frame: surgery after eight 21-day cycles of chemotherapy
pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
4 secondary outcomes
Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Time frame: Cycles 1-4 (21-day cycles)
Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Time frame: Cycles 5-8 (21-day cycles)
Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
Time frame: surgery after eight 21-day cycles of chemotherapy
Disease-free Survival
Time frame: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20732932Schneeweiss A, Marme F, Ruiz A, Manikhas AG, Bottini A, Wolf M, Sinn HP, Mansouri K, Kennedy L, Bauknecht T. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) study chair
Eli Lilly and Company
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed, cyclophosphamide and doxorubicin in people with Breast Cancer, run by Eli Lilly and Company at 11 sites in 4 countries.
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 3 inclusion and 6 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 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Spain, Italy, Russia. 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 13 May 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?
Number of Participants With a Pathological Complete Response (time frame: surgery after eight 21-day cycles of chemotherapy). 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 NCT00149214, 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 21 Mar 2012.