Phase II Study in Patients With Operable Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pegylated Liposomal Doxorubicin (Doxil)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegylated Liposomal Doxorubicin (Doxil)|Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab |  | within 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the complete response rate |  | within 18 weeks | 
| Identify the partial response rate |  | within 18 weeks | 
| Identify the overall response rate |  | within 18 weeks | 
| Evaluate changes in cardiac function |  | within study participation | 
| Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen |  | within study participation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Over-expressing Her2-neu