A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

NCT01432886 | Completed Phase 1 Results

• 1 other identifier: E7389-J081-107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicity (DLT)

  For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.

  Up to 3 weeks

• Number of Participants With Adverse Events

  The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

  From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: E7389

Interventions

E7389 DRUG

Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.

1

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
• Histologically or cytologically confirmed with breast cancer
• Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method
• Subjects who meet any of the following criteria:
• Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
• Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
• Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
• Adequate organ function
• Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1
• Subjects who have submitted written informed consent for study entry

You may not qualify if:

• Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
• Subjects with severe active infection requiring active treatment
• Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
• Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
• Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
• Subjects who are pregnant (positive B-hCG test) or breastfeeding
• Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Kashiwa-shi, Chiba, Japan

Location

Unknown Facility

Hidaka-shi, Saitama, Japan

Location

Related Publications (1)

• Mukai H, Saeki T, Shimada K, Naito Y, Matsubara N, Nakanishi T, Obaishi H, Namiki M, Sasaki Y. Phase 1 combination study of eribulin mesylate with trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 positive breast cancer. Invest New Drugs. 2015 Feb;33(1):119-27. doi: 10.1007/s10637-014-0161-y. Epub 2014 Sep 23.

  PMID: 25242374 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tadashi Nakanishi
• Organization: Eisai Co., Ltd.

81-3-3817-5252

Study Officials

• Tadashi Nakanishi

  Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 13, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 7, 2016
• Results First Posted: March 30, 2015

Record last verified: 2016-08

Locations

JP (2)