Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Overview[ - collapse ][ - ]

Purpose 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).
ConditionBreast Cancer
InterventionDrug: pemetrexed
Drug: cyclophosphamide
Drug: doxorubicin
Drug: docetaxel
PhasePhase 2
SponsorEli Lilly and Company
Responsible PartyEli Lilly and Company
ClinicalTrials.gov IdentifierNCT00149214
First ReceivedSeptember 2, 2005
Last UpdatedMarch 15, 2012
Last verifiedMarch 2012

Tracking Information[ + expand ][ + ]

First Received DateSeptember 2, 2005
Last Updated DateMarch 15, 2012
Start DateSeptember 2005
Estimated Primary Completion DateMarch 2011
Current Primary Outcome MeasuresNumber of Participants With a Pathological Complete Response [Time Frame: surgery after eight 21-day cycles of chemotherapy] [Designated as safety issue: No]pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Current Secondary Outcome Measures
  • Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy [Time Frame: Cycles 1-4 (21-day cycles)] [Designated as safety issue: No]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.
  • Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy [Time Frame: Cycles 5-8 (21-day cycles)] [Designated as safety issue: No]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.
  • Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery [Time Frame: surgery after eight 21-day cycles of chemotherapy] [Designated as safety issue: No]Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
  • Disease-free Survival [Time Frame: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitlePreoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Official TitleA 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
Brief 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).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionBreast Cancer
InterventionDrug: pemetrexed
500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
Other Names:
LY231514, AlimtaDrug: cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
Drug: doxorubicin
60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
Drug: docetaxel
100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Study Arm (s)
  • Experimental: A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
  • Active Comparator: B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment257
Estimated Completion DateMarch 2011
Estimated Primary Completion DateFebruary 2008
Eligibility Criteria
Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesGermany, Italy, Russian Federation, Spain

Administrative Information[ + expand ][ + ]

NCT Number NCT00149214
Other Study ID Numbers7113
Has Data Monitoring CommitteeNo
Information Provided ByEli Lilly and Company
Study SponsorEli Lilly and Company
CollaboratorsNot Provided
Investigators Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Verification DateMarch 2012

Locations[ + expand ][ + ]

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, Germany, 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, Germany, 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, Germany, 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, Germany, D-69115
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, Italy, 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, Italy, 20089
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, Russian Federation, 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, Russian Federation, 197022
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.
Jaen, Spain, 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, Spain, 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, Spain, 46010