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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Preoperative Treatment of Breast Cancer with Two Different Sequential Treatment Regimens
This study is currently recruiting patients.
Verified by Eli Lilly and Company September 2005
|
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 Neoplasms | Drug: Doxorubicin plus Pemetrexed followed by Docetaxel Drug: Doxorubicin plus Cyclophosphamide followed by Docetaxel | Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: Antitumor activity, as measured by the pathologic complete response (pCR) rate in the breast, of neoadjuvant treatment with two different sequential treatment regimens
Secondary Outcomes: Clinical response rates; Rate of histologically negative axillary lymph node status; Disease-free survival; Quantitative and qualitative toxicities
Expected Total Enrollment: 256
Secondary Outcomes: Clinical response rates; Rate of histologically negative axillary lymph node status; Disease-free survival; Quantitative and qualitative toxicities
Expected Total Enrollment: 256
Study start: September 2005; Expected completion: January 2011
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 cm, of Stages T2-T4/N0-2.
- Performance status 0-2(ECOG).
- Adequate organ function (bone marrow, hepatic, renal, cardiac).
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00149214
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Germany
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Heidelberg, 69115, Germany; Recruiting
Study chairs or principal investigators
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST), Study Chair, Eli Lilly and Company
More Information
Study ID Numbers: 7113
Last Updated: September 7, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00149214
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00149214
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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