Phase II Study in Patients With Operable Breast Cancer

Aptium Oncology Research Network

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Pegylated Liposomal Doxorubicin (Doxil)

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00518583

06BR01

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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