A Study of Triciribine Phosphate Monohydrate (TCN-PM)
The investigators hypothesize that the addition of a specific AKT inhibitor (triciribine) to the regimen of weekly paclitaxel (followed sequentially by AC) will enhance the pathologic complete response rate in patients with locally advanced breast cancer.
Metastatic Breast Cancer
Carcinoma Breast Stage IV
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer|
- Recommended phase II dose of triciribine plus weekly paclitaxel. [ Time Frame: Up to 12 weeks after registration and completion of weekly paclitaxel ] [ Designated as safety issue: Yes ]To determine the recommended phase II dose of triciribine used in combination with weekly paclitaxel.
- Pathologic complete response rate (pCR rate) [ Time Frame: After completion of sequential paclitaxel plus triciribine followed by doxorubicin-cyclophopshamide (up to approximately 24 weeks after registration) ] [ Designated as safety issue: No ]To determine the pathologic complete response rate (including breast and breast plus axillary nodes) after sequential weekly paclitaxel triciribine followed by doxorubicin and cyclophosphamide in patients with clinical stage IIB-IIIC breast cancer (phase II).
- Number of Participants with Adverse Events as a Measure of Feasibility and Safety [ Time Frame: each day of the 12 and/or 20 treatment days ] [ Designated as safety issue: Yes ]Evaluate safety and feasibility of the combination of sequential weekly paclitaxel plus triciribine, followed by doxorubicin/cyclophosphamide (phase II portion)
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Triciribine (15, 25, or 35 mg/m2) on days 1, 8, 15 every 28 days
Other Name: TCN-PMDrug: Paclitaxel
Paclitaxel 80 mg/m2 IV infusion over 1 hour weekly x 12 weeks
Other Name: TaxolDrug: Doxorubicin
Doxorubicin 60 mg/m2 IV over 5-10 minutes. Only patients with locally advanced disease eligible for the phase II portion.
Other Name: DOXORUBICIN HYDROCHLORIDEDrug: Cyclophosphamide
Cyclophosphamide 600 mg/m2 IV infusion over 30-60 minutes. Only patients with locally advanced disease eligible for the phase II portion.
Other Name: Cytoxan
|Contact: Joseph Sparano, MDfirstname.lastname@example.org|
|Contact: Shakira Forde, CCRPemail@example.com|
|United States, New York|
|Montefiore Medical Center -Department of Medical Oncology||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Joseph Sparano, MD 718-904-2900 firstname.lastname@example.org|
|Contact: Shakira Forde, CCRP 718-904-2534 email@example.com|
|Principal Investigator: Joseph Sparano, MD|
|Study Chair:||Joseph Sparano, MD||Montefiore Medical Center-Weiler Division|
|Principal Investigator:||Eleni Andreopoulou, MD||Montefiore Medical Center-Weiler Division|
|Principal Investigator:||Christine Pellegrino, MD||Montefiore Medical Center-Moses Division|