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A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu


Phase 2
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab

Outcome Time Frame:

within 18 weeks

Safety Issue:

No

Principal Investigator

John Macdonald, MD

Investigator Role:

Study Director

Investigator Affiliation:

CMO Aptium Oncology

Authority:

United States: Institutional Review Board

Study ID:

06BR01

NCT ID:

NCT00518583

Start Date:

October 2006

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Over-expressing Her2-neu
  • Breast Neoplasms

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs, California  92262
Lynn Regional Cancer Center West Boca Raton, Florida  33428
University of Cincinnati Cincinnati, Ohio  45267-0502
Cedars-Sinai Outpatient Cancer Center Los Angeles, California  
Providence St. Joseph Medical Hospital Burbank, California  91505
Maimonides Cancer Center Brooklyn, New York  11220
St Vincent Comprehensive Cancer Center New York City, New York  10011