Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Locally advanced or metastatic breast cancer

• Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone

• First or second line chemotherapy treatment for metastatic disease

• Karnofsky performance status (KPS) >= 70%

• Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)

• Peripheral neuropathy =< grade 1

• Absolute neutrophil count >= 1,500/mm^3

• Platelets >= 100,000 cells/mm^3

• Hemoglobin (Hb) >= 9.0 g/dl

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal

• Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases

• Bilirubin =< 1.5 mg/dl

• Creatinine clearance (calculated or 24 hour) >= 30 ml/min

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients may not be receiving any other investigational agents

• Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids

• Known history of allergic reactions to paclitaxel

• Presence of any serious or uncontrolled infection

• Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months