Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: pemetrexed; Drug: cyclophosphamide; Drug: doxorubicin; Drug: docetaxel	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	257 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	September 2005
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	March 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel	Drug: pemetrexed; 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4); Other Name: LY231514, Alimta 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)
Active Comparator: B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel	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)

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Germany
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
Italy
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
Russian Federation
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
Spain
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

Sponsors and Collaborators

Eli Lilly and Company

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

Publications of Results:

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. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00149214 History of Changes
Other Study ID Numbers:	7113; H3E-MC-S080 ( Other Identifier: Eli Lilly and Company )
First Posted:	September 8, 2005
Results First Posted:	May 13, 2009
Last Update Posted:	March 21, 2012
Last Verified:	March 2012

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cyclophosphamide; Docetaxel; Liposomal doxorubicin; Doxorubicin; Pemetrexed; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents	Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors