Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00149214
First received: September 2, 2005
Last updated: March 15, 2012
Last verified: March 2012

September 2, 2005
March 15, 2012
September 2005
February 2008   (final data collection date for primary outcome measure)
Number 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
Antitumor activity, as measured by the pathologic complete response (pCR) rate in the breast, of neoadjuvant treatment with two different sequential treatment regimens
Complete list of historical versions of study NCT00149214 on ClinicalTrials.gov Archive Site
  • 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.
  • Clinical response rates
  • Rate of histologically negative axillary lymph node status
  • Disease-free survival
  • Quantitative and qualitative toxicities
Not Provided
Not Provided
 
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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)
  • 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
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):609-17. Epub 2010 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
March 2011
February 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Russian Federation,   Spain
 
NCT00149214
7113, H3E-MC-S080
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
March 2012

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