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

NCT01463072 | Active Not Recruiting Phase 2 Results DMC

• 5 other identifiers: 11139NCI-2011-03295118196124494P30CA033572
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (4)

• Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0

  Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.

  During and after treatment, up to 2.5 years

• Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment

  Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment.

  On treatment, 28 days per cycle up to 30 months

• Rate of Participants With a Dose Reduction

  Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.

  On treatment, up to 30 months

• Rate of Participants Requiring Dose Holds

  Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.

  While on treatment, up to 30 months

Secondary Outcomes (3)

• Response Determined by Response Evaluation Criteria in Solid Tumors

  Up to 2.5 years

• Median Progression Free Survival (PFS)

  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

• Cancer-specific Geriatric (CARG) Assessment

  CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months

Study Arms (1)

Treatment (nab-paclitaxel)

EXPERIMENTAL

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.

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (nab-paclitaxel)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, protein-bound paclitaxel

Treatment (nab-paclitaxel)

Questionnaire Administration OTHER

Ancillary studies

Treatment (nab-paclitaxel)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope medical

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 30503309 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Mina Sedrak
• Organization: City of Hope

msedrak@coh.org

626-359-8111

Study Officials

• Mina Sedrak

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 1, 2011
• Study Start: June 19, 2012
• Primary Completion: May 17, 2017
• Study Completion (Estimated): May 18, 2026
• Last Updated: July 28, 2025
• Results First Posted: July 26, 2022

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)