Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
Drug: pegylated liposomal doxorubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer|
- Pathological Complete Response [ Time Frame: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment. ] [ Designated as safety issue: No ]
- Clinical Complete Response [ Time Frame: Surgery done after completion of six cycles of study chemotherapy treatment. ] [ Designated as safety issue: No ]
- Overall Clinical Local Regional Response [ Time Frame: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment. ] [ Designated as safety issue: No ]
- Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy [ Time Frame: Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome. ] [ Designated as safety issue: No ]
- Safety, in Terms of Neutropenia and Cardiac Toxicity [ Time Frame: Every cycle during study treatment and 8 weeks post-treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.
- To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
- To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
- To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.
OUTLINE: This is a multicenter study.
Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy.
After completion of study therapy, patients are followed periodically for up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524459
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Tracey O'Connor, MD||Roswell Park Cancer Institute|