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Phase I/II Study of Neoadjuvant Carboplatin, Eribulin Mesylate and Trastuzumab (ECH) for Operable HER2 Positive Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
HER-2 Positive Breast Cancer

Thank you

Trial Information

Phase I/II Study of Neoadjuvant Carboplatin, Eribulin Mesylate and Trastuzumab (ECH) for Operable HER2 Positive Breast Cancer


Inclusion Criteria:



- Written informed consent

- Females; 18 years of age or greater

- Histologically proven invasive breast cancer

- American Joint Committee on Cancer (AJCC) clinical stage IIA - IIIB

- Tumor size greater than 10 millimeters

- HER2 positive

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Estrogen receptor (ER) positive or negative

- Ejection fraction greater than or equal to lower limit of normal for the institution
by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)

- Less than or equal to Grade 1 neuropathy according to Common Terminology Criteria for
Adverse Events (CTCAE) version 4.0

- Planned lumpectomy or mastectomy

- Eligible for radiation therapy

- No prior treatment for invasive breast cancer

- Adequate organ system function per protocol as determined within 7 days prior to
first dose of study treatment

- Women of childbearing potential must have a negative pregnancy test within 7 days
prior to the first dose of study treatment and must agree to use adequate
contraception methods during study treatment and for a minimum of 6 months following
trastuzumab discontinuation

- Female subjects who are lactating should discontinue nursing prior to the first dose
of study treatment and should refrain from nursing throughout the treatment period

Exclusion Criteria:

- Fine needle cytology only without other histologic evidence of invasive breast cancer

- Inflammatory breast cancer

- AJCC clinical stage T1a-b breast cancer (primary tumor less than or equal to 10
millimeters)

- Evidence of metastatic disease

- HER2 negative

- Ejection fraction less than lower limit of normal for the institution by ECHO or MUGA

- Corrected QT interval greater than 480 milliseconds

- Pre-existing cardiac dysfunction

- Prior history of invasive cancer within the past 3 years

- Synchronous bilateral breast cancer

- Pre-existing CTCAE v4.0 Grade 2 or greater neuropathy

- Hypersensitivity to halichondrin B or halichondrin B chemical derivative

- History of severe allergic reactions to cisplatin or other platinum containing
compounds, or mannitol

- Mild, moderate, or severe hepatic impairment

- Moderate or severe renal impairment

- Hypokalemia or hypomagnesemia if it cannot be corrected prior to the first dose of
study treatment

- Organ allografts requiring immunosuppression

- Known positive human immunodeficiency virus (HIV) status

- Prior major surgery within 28 days prior to the first dose of study treatment and/or
presence of any non-healing wound, fracture, or ulcer

- Minor surgery or radiation therapy within 14 days prior to the first dose of study
treatment

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy as measured by pathologic complete response at surgery

Outcome Description:

Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response, partial pathologic response, or no response.

Outcome Time Frame:

Assessed at time of definitive surgery, 3 to 8 weeks after completion of study treatment

Safety Issue:

No

Principal Investigator

Lee Schwartzberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

ACORN Research, LLC and The West Clinic

Authority:

United States: Institutional Review Board

Study ID:

ACORN ALSSNBC1006

NCT ID:

NCT01388647

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • HER-2 Positive Breast Cancer
  • Neoadjuvant Treatment
  • HER-2 Positive Breast Cancer
  • Breast Neoplasms

Name

Location

Holy Cross HospitalFort Lauderdale, Florida  33308
The West ClinicMemphis, Tennessee  38120
Northwest Georgia Oncology CentersMarietta, Georgia  30060
Northeast Georgia Cancer CareAthens, Georgia  30607