Clinical trial NCT01463072: Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Official title: Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Breast Carcinoma
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma
Stage III Breast Cancer AJCC v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
timeFrame: During and after treatment, up to 2.5 years
measure: Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
timeFrame: On treatment, 28 days per cycle up to 30 months
measure: Rate of Participants With a Dose Reduction
timeFrame: On treatment, up to 30 months
measure: Rate of Participants Requiring Dose Holds
timeFrame: While on treatment, up to 30 months
Secondary outcomes:
measure: Response Determined by Response Evaluation Criteria in Solid Tumors
timeFrame: Up to 2.5 years
measure: Median Progression Free Survival (PFS)
timeFrame: From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
measure: Cancer-specific Geriatric (CARG) Assessment
timeFrame: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope medical
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: City of Hope Medical Center
name: Mina Sedrak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurria A, Soto-Perez-de-Celis E, Blanchard S, Burhenn P, Yeon CH, Yuan Y, Li D, Katheria V, Waisman JR, Luu TH, Somlo G, Noonan AM, Lee T, Sudan N, Chung S, Rotter A, Arsenyan A, Levi A, Choi J, Rubalcava A, Morrison R, Mortimer JE. A Phase II Trial of Older Adults With Metastatic Breast Cancer Receiving nab-Paclitaxel: Melding the Fields of Geriatrics and Oncology. Clin Breast Cancer. 2019 Apr;19(2):89-96. doi: 10.1016/j.clbc.2018.10.002. Epub 2018 Oct 16.