Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00524459
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Primary Completion: 2008-08
• Status Verified: 2014-08
• Results First Submitted: 2014-08-06
• Results First Submitted QC: 2014-08-06
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-08-22
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response	Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Clinical Complete Response	Surgery done after completion of six cycles of study chemotherapy treatment.

Secondary Outcome Measures

Name	Time	Method
Safety, in Terms of Neutropenia and Cardiac Toxicity	Every cycle during study treatment and 8 weeks post-treatment.
Overall Clinical Local Regional Response	Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy	Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States