Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens - Full Text View

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).

Condition	Intervention	Phase
Breast Cancer	Drug: pemetrexed Drug: cyclophosphamide Drug: doxorubicin Drug: docetaxel	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Docetaxel Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

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.


Enrollment:	257
Study Start Date:	September 2005
Study Completion Date:	March 2011
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149214

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
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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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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):609-17. 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
Study First Received:	September 2, 2005
Results First Received:	February 11, 2009
Last Updated:	March 15, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 27, 2016