Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: everolimus; Drug: abraxane

• Registration Number: NCT00934895
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with everolimus may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well it works in treating women with locally advanced or metastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

* To determine the maximum tolerated dose and recommended phase II dose of everolimus when administered in combination with paclitaxel albumin-stabilized nanoparticle formulation in women with locally advanced or metastatic breast cancer. (Phase I)

* To determine the antitumor activity of this regimen, as measured by clinical tumor response according to RECIST criteria, in these patients. (Phase II)

Secondary

* To determine the safety and tolerability of everolimus when administered at the recommended phase II dose in combination with paclitaxel albumin-stabilized nanoparticle formulation in these patients.

OUTLINE: This is a multicenter, phase I dose-escalation study of everolimus followed by a phase II study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral everolimus once daily or once every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Study Timeline

• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Study Start: 2009-07-15
• Primary Completion: 2014-01-07
• Study Completion: 2015-08-12
• Results First Submitted: 2017-03-31
• Results First Submitted QC: 2022-10-08
• Results First Posted: 2022-11-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I / Phase II	abraxane	Phase I: * Abraxane will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle. * RAD001 will be given by tablet. The first group of patients will receive RAD001 once daily depending on side effects seen drug could be increased later to twice a day for a 28 day cycle. Once a safe and effective drug range is established, the study moves into Phase II. Phase II: The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination. * Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle). * RAD001 will be given by tablet based on the dose established in the Phase I part of the study.
Phase I / Phase II	everolimus	Phase I: * Abraxane will be given by IV for 30 minutes on the first day of the first three weeks of each 28 day cycle. * RAD001 will be given by tablet. The first group of patients will receive RAD001 once daily depending on side effects seen drug could be increased later to twice a day for a 28 day cycle. Once a safe and effective drug range is established, the study moves into Phase II. Phase II: The maximum tolerated dose (established in Phase I) will be given as scheduled below and we will measure the effectiveness of the study drug combination. * Abraxane will be given by IV (intravenous infusion) for 30 minutes on the first day of the first three weeks of each 28 day cycle (Day 1, Day 8, and Day 15 of each cycle). * RAD001 will be given by tablet based on the dose established in the Phase I part of the study.

Primary Outcome Measures

Name	Time	Method
To Determine the Maximum Tolerated Dose (MTD) of RAD001 in Combination of Weekly Abraxane and Determine the Phase II Dose of RAD001.	5 yrs

Trial Locations

Locations (3)

Rutgers Cancer Institute of New Jersey (Hamilton); 🇺🇸 Hamilton, New Jersey, United States

Cooper Hospital/University Medical Center; 🇺🇸 Camden, New Jersey, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States