Clinical trial NCT01432886: A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
Official title: A Phase 1 Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 3 weeks
measure: Number of Participants With Adverse Events
timeFrame: From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
state: Chiba
city: Hidaka-shi
country: Japan
state: Saitama
Study officials:
affiliation: Eisai Co., Ltd.
name: Tadashi Nakanishi
role: STUDY_DIRECTOR
References:
citation: 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.