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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 InstituteBuffalo, New York  14263
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
Lynn Regional Cancer Center WestBoca Raton, Florida  33428
University of CincinnatiCincinnati, Ohio  45267-0502
Cedars-Sinai Outpatient Cancer CenterLos Angeles, California  
Providence St. Joseph Medical HospitalBurbank, California  91505
Maimonides Cancer CenterBrooklyn, New York  11220
St Vincent Comprehensive Cancer CenterNew York City, New York  10011