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Phase II Neoadjuvant Trial With Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-negative Breast Cancer

Thank you

Trial Information

Phase II Neoadjuvant Trial With Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients


PRIMARY OBJECTIVES:

I. To determine the pathologic complete response rate (pCR) at the time of definitive
surgery.

SECONDARY OBJECTIVES:

I. Determination of the clinical response rate, as measured by clinical exam and imaging
studies prior to initiation of therapy and prior to surgery.

II. Measurement of alpha B-crystalline in tissue obtained before initiation of therapy and
at the time of definitive surgery.

III. Stem cell markers (cluster of differentiation [CD]44+, CD24-, CD133, aldehyde
dehydrogenase 1 [ALDH1] and evaluation of the NOTCH pathway) in tissue obtained before
initiation of therapy and at the time of definitive surgery.

IV. Measurement of proliferation markers (Ki67) before and after treatment in tissue
obtained before imitation of therapy and at the time of definitive surgery.

V. Measurement of beta III tubulin in tissue obtained before initiation of therapy and at
the time of definitive surgery.

VI. Measurement of Tau in tissue obtained before initiation of therapy and at the time of
definitive surgery.

VII. Safety evaluation, including following of patients for alopecia and neuropathy.

VIII. Epidermal growth factor receptor (EGFR) staining before and after treatment in tissue
obtained before initiation of therapy and at the time of definitive surgery.

OUTLINE:

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes and carboplatin IV
over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.


Inclusion Criteria:



- Patients must have histologically confirmed breast cancer; diagnosis must be reviewed
and confirmed by the pathology department at Northwestern Memorial Hospital prior to
registration on study, and all biopsy materials need to be reviewed and available for
correlative studies

- Patients must have stage I-III breast cancer

- Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative
(PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or
fluorescent in situ hybridization (FISH) < ratio of 1.8

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) by
mammogram, ultrasound or physical exam

- Prior diagnosis of cancer is allowed as long as patient is free of disease and has
been off treatment for the prior malignancy for a minimal interval of one year

- Patients must have a life expectancy of > 12 weeks

- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status
=< 1 (Karnofsky >= 80%)

- Leukocytes >= 3,000/ul

- Absolute neutrophil count >= 1,500/ul

- Platelets >= 100,000/ul

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/
alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X
institutional upper limit of normal

- Creatinine: within normal institutional limits

- OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine levels above
institutional normal

- Women of childbearing potential must commit to the use of effective contraception
while on study

- Eligibility of patients receiving medications of substances known to affect, or with
the potential to affect, the activity or pharmacokinetics of eribulin will be
determined following review of their use by the Principal Investigator

- All patients must have given signed, informed consent prior to registration on study

Exclusion Criteria:

- Prior chemotherapy, immunotherapy or hormonal therapy for breast cancer is NOT
allowed

- Concomitant radiotherapy is NOT allowed

- Patients may NOT be receiving any other investigational agents or concurrent
anticancer therapies; in addition, use of any herbal (alternative) medicines is NOT
permitted

- Patients with uncontrolled inter-current illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations what would
limit compliance with study requirements are NOT eligible to participate

- Women who are pregnant or lactating are NOT eligible to participate

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the pathologic complete response rate (pCR).

Outcome Time Frame:

Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

Safety Issue:

No

Principal Investigator

Virginia Kaklamani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

NU 10B07

NCT ID:

NCT01372579

Start Date:

August 2011

Completion Date:

June 2018

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • HER2-negative Breast Cancer
  • Male Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male

Name

Location

Northwestern UniversityChicago, Illinois  60611