Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 |
| 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
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 | |
| 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
Additional Information:
Publications:
| 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:
|
Cyclophosphamide Docetaxel Doxorubicin Liposomal doxorubicin Pemetrexed Alkylating Agents Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents |
Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors Tubulin Modulators |
ClinicalTrials.gov processed this record on March 03, 2015