Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

NCT01372579 | Unknown Phase 2 DMC

• 3 other identifiers: NU 10B07NCI-2011-00600STU00045038
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To determine the pathologic complete response rate (pCR).

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

Secondary Outcomes (8)

• Measurement of alpha B-crystalline in tissue obtained

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

• Stem cell markers (CD44+, CD24-, CD133, ALDH1 and evaluation of the NOTCH pathway) in tissue

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

• Measurement of proliferation markers (Ki67)

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

• Measurement of beta III tubulin in tissue

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

• Measurement of Tau in tissue

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

Study Arms (1)

Treatment (neoadjuvant chemotherapy)

EXPERIMENTAL

Patients receive eribulin mesylate 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.

Drug: eribulin mesylate; Drug: carboplatin; Procedure: biopsy

Interventions

eribulin mesylate DRUG

Given IV

Also known as: Halaven, B1939, E7389, ER-086526, halichrondrin B analog

Treatment (neoadjuvant chemotherapy)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (neoadjuvant chemotherapy)

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Treatment (neoadjuvant chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Eisai Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Kaklamani VG, Jeruss JS, Hughes E, Siziopikou K, Timms KM, Gutin A, Abkevich V, Sangale Z, Solimeno C, Brown KL, Jones J, Hartman AR, Meservey C, Jovanovic B, Helenowski I, Khan SA, Bethke K, Hansen N, Uthe R, Giordano S, Rosen S, Hoskins K, Von Roenn J, Jain S, Parini V, Gradishar W. Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early-stage breast cancer (NCT01372579). Breast Cancer Res Treat. 2015 Jun;151(3):629-38. doi: 10.1007/s10549-015-3435-y. Epub 2015 May 26.

  PMID: 26006067 DERIVED

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

eribulin; Carboplatin; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Virginia Kaklamani, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 14, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: June 7, 2019

Record last verified: 2019-05

Locations

US (1)