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

City of Hope

Status and phase: Active, not recruiting; Phase 2

Conditions: Stage III Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Recurrent Breast Carcinoma; Stage IIIA Breast Cancer AJCC v7; Metastatic Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7; Locally Advanced Breast Carcinoma; Stage IIIB Breast Cancer AJCC v7

Treatments: Other: Laboratory Biomarker Analysis; Drug: Nab-paclitaxel; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01463072

P30CA033572 (U.S. NIH Grant/Contract)

11139

NCI-2011-03295 (Registry Identifier)

118196

124494

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).

II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.

OUTLINE:

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

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

Enrollment: 40 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment (nab-paclitaxel)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Drug: Nab-paclitaxel

Other: Laboratory Biomarker Analysis