Clinical trial NCT00518583: Phase II Study in Patients With Operable Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Over-expressing Her2-neu
Lead sponsor: Aptium Oncology Research Network
Sponsor class: NETWORK
Collaborators: name: Ortho Biotech Products, L.P.
First posted: 2007-08-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
timeFrame: within 18 weeks
Secondary outcomes:
measure: Identify the complete response rate
timeFrame: within 18 weeks
measure: Identify the partial response rate
timeFrame: within 18 weeks
measure: Identify the overall response rate
timeFrame: within 18 weeks
measure: Evaluate changes in cardiac function
timeFrame: within study participation
measure: Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
timeFrame: within study participation
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence St. Joseph Medical Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center Comprehensive Cancer Center
state: California
city: Boca Raton
country: United States
facility: Lynn Regional Cancer Center West
state: Florida
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Brooklyn
country: United States
facility: Maimonides Cancer Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York City
country: United States
facility: St Vincent Comprehensive Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: CMO Aptium Oncology
name: John Macdonald, MD
role: STUDY_DIRECTOR
References: