Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer

NCT02037529 | Suspended Phase 3 Results DMC FDA Drug

• 3 other identifiers: RU011201INCI-2016-02048P30CA015083
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 39

Brief Summary

This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and 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

Breast Adenocarcinoma; HER2/Neu Negative; Invasive Breast Carcinoma; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (2)

• Cumulative Dose Level Triggering a Grade 2 or Higher Neuropathy Event.

  To validate rs7349683 in EPHA5 as a predictor of peripheral neuropathy from treatment with a microtubule targeting agent (i.e., eribulin or paclitaxel) over the first 6 months of treatment we will compare the median cumulative dose level triggering a grade 2 or higher neuropathy event.

  6 months

• Mean Change in Patient Reported PRO-CTCAE

  To demonstrate that patient-reported PRO-CTCAE data will be able to detect differences in symptoms between participants treated with eribulin and standard weekly paclitaxel at 12 weeks we will compare the mean change of overall Pro-CTCAE score by treatment arm. The overall Pro-CTCAE score is a normalized score scaled from 20 questions, each with a possible 1-5 patient selection, creating an overall score (0-100) where 0 represents the best outcome and 100 represents the worst possible outcome. The mean change from baseline to week 12 is reported.

  12 weeks

Secondary Outcomes (9)

• Overall Survival (OS)

  81 months

• Objective Tumor Response Rate

  64 months

• Duration of Response

  75 months

• Time to Treatment Failure

  64 months

• Incidence of Treatment Related Adverse Events

  64 months

Other Outcomes (1)

• New Metastasis Free Survival

  Up to 5 years

Study Arms (2)

Arm A (eribulin mesylate)

EXPERIMENTAL

Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Eribulin Mesylate; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Arm B (paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment

Interventions

Eribulin Mesylate DRUG

Given IV

Also known as: B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog

Arm A (eribulin mesylate)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (eribulin mesylate); Arm B (paclitaxel)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm B (paclitaxel)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (eribulin mesylate); Arm B (paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent document signed and dated by patient
• Histologic confirmation of invasive adenocarcinoma originating in the breast
• Stage IV disease or stage IIIC disease (using the 7th edition American Joint Committee on Cancer \[AJCC\] criteria) not amenable to local therapy
• Clinical or radiographic evidence of disease progression
• Documentation of HER2 negative breast cancer at the time of protocol registration; (Note: HER2 negativity is defined as 0 or 1+ by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization \[FISH\]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
• Known hormone receptor status at the time of protocol registration; (Note: estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] status are considered positive with a cut-off of \>= 1% invasive tumor cells; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
• Patients must demonstrate resolution of all toxicities related to prior chemotherapy, endocrine therapy, targeted therapy, or biologic therapy to grade =\< 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible)
• No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed \>= 14 days prior to randomization
• Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen
• Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen
• If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen
• If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen
• If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen
• If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
• Prior treatment may include a taxane as per the following criteria:

You may not qualify if:

• Prior malignancy, other than carcinoma in situ of the cervix and non-melanoma skin cancers, unless the prior malignancy was diagnosed and definitively treated \>= 5 years previously, there is no subsequent evidence of recurrence, and the patient is considered by a physician to be at \< 30% risk of relapse
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Presence of a serious nonhealing wound, ulcer, or bone fracture
• History of Common Terminology Criteria for Adverse Events (CTCAE) grade \>= 3 hypersensitivity to paclitaxel or Cremophor EL
• Pre-existing peripheral neuropathy grade ?= 2 at registration
• Significant cardiovascular impairment (e.g., New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
• Subjects with known positive human immunodeficiency virus (HIV) status
• History of stroke or transient ischemic attack =\< 6 months prior to registration
• History of uncontrolled seizures; (Note: patients are eligible for the study if the seizures are well controlled with standard medications)
• Severe or uncontrolled intercurrent illness/infection
• Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer
• Prior exposure to eribulin mesylate

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• National Cancer Institute (NCI): collaborator

Study Sites (39)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Carle Cancer Center NCI Community Oncology Research Program

Urbana, Illinois, 61801, United States

Location

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Ochsner NCI Community Oncology Research Program

New Orleans, Louisiana, 70121, United States

Location

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412, United States

Location

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States

Location

Essentia Health NCI Community Oncology Research Program

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64507, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Heartland Cancer Research CCOP

St Louis, Missouri, 63131, United States

Location

Cancer Alliance of Nebraska

Omaha, Nebraska, 68106, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, 13057, United States

Location

Mission Hospital-Saint Joseph Campus

Asheville, North Carolina, 28801, United States

Location

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, 27215, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Minetta Liu
• Organization: Mayo Clinic

Liu.Minetta@mayo.edu

5072930526

Study Officials

• Minetta C Liu

  Academic and Community Cancer Research United

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: January 17, 2014
• Primary Completion: February 11, 2021
• Study Completion: October 31, 2024
• Last Updated: August 20, 2024
• Results First Posted: September 6, 2023

Record last verified: 2023-08

Locations

US (39)