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Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

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ClinicalTrials.gov Identifier: NCT00149214
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : May 13, 2009
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 8, 2005
Results First Submitted Date  ICMJE February 11, 2009
Results First Posted Date  ICMJE May 13, 2009
Last Update Posted Date March 21, 2012
Study Start Date  ICMJE September 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2009)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Antitumor activity, as measured by the pathologic complete response (pCR) rate in the breast, of neoadjuvant treatment with two different sequential treatment regimens
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy [ Time Frame: Cycles 1-4 (21-day cycles) ]
    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) ]
    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 ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • Clinical response rates
  • Rate of histologically negative axillary lymph node status
  • Disease-free Survival
  • Quantitative and qualitative toxicities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: pemetrexed
    500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
    Other Name: LY231514, Alimta
  • Drug: 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 Arms  ICMJE
  • Experimental: A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
    Interventions:
    • Drug: pemetrexed
    • Drug: doxorubicin
    • Drug: docetaxel
  • Active Comparator: B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
    Interventions:
    • Drug: cyclophosphamide
    • Drug: doxorubicin
    • Drug: docetaxel
Publications * Schneeweiss A, Marmé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2009)
257
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
256
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00149214
Other Study ID Numbers  ICMJE 7113
H3E-MC-S080 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP