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

NCT ID: NCT01432886

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E7389

Intervention Type: 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.

Interventions

E7389

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tadashi Nakanishi

Role: STUDY_DIRECTOR

Eisai Co., Ltd.

Locations

Kashiwa-shi, Chiba, Japan

Hidaka-shi, Saitama, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 25242374 (View on PubMed)

Other Identifiers

E7389-J081-107

Identifier Type: -

Identifier Source: org_study_id