ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+200 other locations

Overseen by Tom R. Fitch, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, 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) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Research Team

Philip J. Stella, MD

Principal Investigator

CCOP - Michigan Cancer Research Consortium

Timothy J. Hobday, M.D.

Principal Investigator

Mayo Clinic

Vivek Roy, MD, FACP

Principal Investigator

Mayo Clinic

Tom R. Fitch, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed invasive breast cancer

- Clinical evidence of metastatic disease

+ No bone metastases or other non-measurable disease as the only evidence of metastasis

Treatment Details

Interventions

• Gemcitabine (Anti-metabolites)
• Paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Anti-metabolites)

Participant Groups

Group I: Nab-paclitaxel/Gemcitabine Experimental Treatment 2 Interventions

Gemcitabine is already approved in Canada, Japan for the following indications:

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School