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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 Hospital Fort Lauderdale, Florida  33308
The West Clinic Memphis, Tennessee  38120
Northwest Georgia Oncology Centers Marietta, Georgia  30060
Northeast Georgia Cancer Care Athens, Georgia  30607