This trial is active, not recruiting.

Condition breast cancer
Treatment pegylated liposomal doxorubicin (doxil)
Phase phase 2
Sponsor Aptium Oncology Research Network
Collaborator Ortho Biotech Products, L.P.
Start date October 2006
End date January 2009
Trial size 30 participants
Trial identifier NCT00518583, 06BR01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
time frame: within 18 weeks

Secondary Outcomes

Identify the complete response rate
time frame: within 18 weeks
Identify the partial response rate
time frame: within 18 weeks
Identify the overall response rate
time frame: within 18 weeks
Evaluate changes in cardiac function
time frame: within study participation
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen
time frame: within study participation

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Aptium Oncology Research Network.