Phase II Study in Patients With Operable Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Aptium Oncology Research Network.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Aptium Oncology Research Network
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Aptium Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00518583
First received: August 16, 2007
Last updated: January 14, 2010
Last verified: January 2010
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Purpose
The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Pegylated Liposomal Doxorubicin (Doxil) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu |
Resource links provided by NLM:
Further study details as provided by Aptium Oncology Research Network:
Primary Outcome Measures:
- Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Identify the complete response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
- Identify the partial response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
- Identify the overall response rate [ Time Frame: within 18 weeks ] [ Designated as safety issue: No ]
- Evaluate changes in cardiac function [ Time Frame: within study participation ] [ Designated as safety issue: Yes ]
- Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen [ Time Frame: within study participation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Pegylated Liposomal Doxorubicin (Doxil)
- taxol (paclitaxel)
- herceptin
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly
Other Names:
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Dx of clinical T1c-T3, N0-1, M0 breast cancer
- Interval between diagnosis and consent of <- 62 days
- Life expectancy of 10 years
- LVEF by MUGA >= lower limit of normal for the testing facility
- Negative serum pregnancy test
- Adequate bone marrow, renal, liver function
- Negative bone scan
- HRT discontinued before study entry
- Adequate contraceptive methods
Exclusion Criteria:
- Male breast cancer
- Less than 21 years of age
- Ulceration, infiltration of the skin, complete fixation or severe skin edema
- N3 disease in which nodes are matted and fixed
- Suspicious palpable supraclavicular nodes
- CT evidence of malignant internal mammary nodes
- Pregnancy or breast feeding at time of study entry
- Prior therapy for breast cancer
- Prior anthracycline for any malignancy
- Prior breast malignancy of the contralateral breast
- Prior non-breast malignancy within 5 years
- Non-malignant disease that would preclude follow up
- MI within 6 months, NYHA Class II or greater heart failure
- Psychiatric disorders or conditions that would preclude provision of informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518583
Locations
| United States, California | |
| Providence St. Joseph Medical Hospital | |
| Burbank, California, United States, 91505 | |
| Cedars-Sinai Outpatient Cancer Center | |
| Los Angeles, California, United States, 90048 | |
| Desert Regional Medical Center Comprehensive Cancer Center | |
| Palm Springs, California, United States, 92262 | |
| United States, Florida | |
| Lynn Regional Cancer Center West | |
| Boca Raton, Florida, United States, 33486 | |
| United States, Illinois | |
| John H. Stroger, Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| Maimonides Cancer Center | |
| Brooklyn, New York, United States, 11220 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| St Vincent Comprehensive Cancer Center | |
| New York City, New York, United States, 10011 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45221 | |
Sponsors and Collaborators
Aptium Oncology Research Network
Ortho Biotech Products, L.P.
Investigators
| Study Director: | John Macdonald, MD | CMO Aptium Oncology |
More Information
No publications provided
| Responsible Party: | Marti McKinley, Aptium Oncology Research Network |
| ClinicalTrials.gov Identifier: | NCT00518583 History of Changes |
| Other Study ID Numbers: | 06BR01 |
| Study First Received: | August 16, 2007 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Aptium Oncology Research Network:
|
Breast cancer Over-expressing Her2-neu |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Doxorubicin Trastuzumab Paclitaxel Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013