Phase II Study in Patients With Operable Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00518583
• Other study ID #: 06BR01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: January 14, 2010
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: Aptium Oncology Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pegylated Liposomal Doxorubicin (Doxil)
Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly

Locations

Country	Name	City	State
United States	Lynn Regional Cancer Center West	Boca Raton	Florida
United States	Maimonides Cancer Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence St. Joseph Medical Hospital	Burbank	California
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cedars-Sinai Outpatient Cancer Center	Los Angeles	California
United States	St Vincent Comprehensive Cancer Center	New York City	New York
United States	Desert Regional Medical Center Comprehensive Cancer Center	Palm Springs	California

Sponsors (2)

Lead Sponsor	Collaborator
Aptium Oncology Research Network	Ortho Biotech Products, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab		within 18 weeks	No
Secondary	Identify the complete response rate		within 18 weeks	No
Secondary	Identify the partial response rate		within 18 weeks	No
Secondary	Identify the overall response rate		within 18 weeks	No
Secondary	Evaluate changes in cardiac function		within study participation	Yes
Secondary	Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen		within study participation	Yes