Chemotherapy for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Mina Sedrak

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria

This trial is for older adults with breast cancer that has spread locally or to other body parts. Participants need a certain level of kidney function, blood cell counts, and liver health; they must understand the study and agree to participate. They should be relatively fit (KPS >= 70%) and not have had taxane drugs recently or severe nerve damage from past treatments.

Inclusion Criteria

I am receiving my first or second round of chemotherapy for cancer that has spread.

Your platelet count is at least 100,000 cells per cubic millimeter.

My alkaline phosphatase levels are normal or slightly elevated, and I don't have liver metastases.

Exclusion Criteria

I am allergic to paclitaxel.

I have brain metastases that haven't been treated or need more steroids to manage symptoms.

Patients may not be receiving any other investigational agents

Participant Groups

The trial is testing nab-paclitaxel's effectiveness in managing advanced breast cancer in older patients. It looks at how well this chemotherapy drug works alone without combining it with other treatments, focusing on its safety profile and impact on tumor growth.

Group I: Treatment (nab-paclitaxel) Experimental Treatment 3 Interventions

Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

🇪🇺 Approved in European Union as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

🇨🇦 Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope medical Duarte, CA

City of Hope Antelope Valley Lancaster, CA

City of Hope South Pasadena South Pasadena, CA

Ohio State University Comprehensive Cancer Center Columbus, OH

Who Is Running the Clinical Trial?

City of Hope Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References