Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: Intraductal armDrug: Intravenous arm
- Registration Number
- NCT00290732
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given before mastectomy in treating women with invasive breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy.
Secondary
* Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome, including serial plasma concentrations of doxorubicin and doxorubicinol and tissue concentrations in different portions of the breast at the time of surgery.
OUTLINE: This is a dose-escalation study.
Patients receive an intraductal injection of pegylated doxorubicin HCl liposome\* on day 1. Patients undergo mastectomy 2-4 weeks later.
Cohorts of 3-6 patients receive escalating doses of pegylated doxorubicin HCl liposome\* until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
NOTE: \*The first cohort of 3 patients receive intraductal dextrose only followed by surgery as a feasibility study. An additional 3 patients receiving intravenous PLD will be enrolled in a pharmacokinetic control portion of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intraductal arm Intraductal arm Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer. Intravenous arm Intravenous arm Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) Until up to 30 days after PLD administration Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.
- Secondary Outcome Measures
Name Time Method Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.
Concentrations of Doxorubicin in Tissue at Definitive Surgery Day of surgery/biopsy Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.
Trial Locations
- Locations (2)
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States