Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

This study is currently recruiting participants.
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01593020
First received: May 3, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).

Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.

5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.


Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel
Drug: Eribulin
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pathologic Complete Response (pCR) [ Time Frame: 4 -6 weeks from last dose of FAC/FEC-regimen. ] [ Designated as safety issue: Yes ]
    Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.


Estimated Enrollment: 162
Study Start Date: August 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel

ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.

Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.

Drug: Paclitaxel
80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.
Other Name: Taxol
Drug: 5-Fluorouracil
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • 5-FU
  • Adrucil
  • Efudex
Drug: Epirubicin
100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin
50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex
Experimental: Eribulin

ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).

Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.

Drug: Eribulin
1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.
Other Name: E7389
Drug: 5-Fluorouracil
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • 5-FU
  • Adrucil
  • Efudex
Drug: Epirubicin
100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Name: Ellence
Drug: Cyclophosphamide
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin
50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent
  2. Histologically confirmed primary invasive adenocarcinoma of the breast.
  3. Clinical stage breast cancer T2-3, N0-3, M0
  4. Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).
  5. No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.
  6. Karnofsky performance status (KPS) of 80 - 100
  7. The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  8. Baseline MUGA or echocardiogram scans with LVEF of > 50%.
  9. Normal PTT and either INR or PT < 1.5 x ULN.
  10. Men or women 18 years of age or older.
  11. Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.
  12. Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.

Exclusion Criteria:

  1. Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
  2. Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.
  3. Absolute neutrophils count (ANC) < 1500/mm^3
  4. Total bilirubin > 1.5 times the upper limit of normal (ULN)
  5. AST or ALT > 2.5 times the upper limit of normal (ULN)
  6. Platelets < 100,000/mm^3.
  7. Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)
  8. Evidence of metastatic breast cancer following a standard tumor staging work-up
  9. Evidence of inflammatory breast cancer.
  10. Evidence of any grade 2 sensory or motor neuropathy.
  11. Known human immunodeficiency viral (HIV) infection
  12. Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.
  13. Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593020

Contacts
Contact: Ricardo H Alvarez, MD,M.Sc. 713-792-2817

Locations
United States, Texas
UT MD Andreson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Ricardo H Alvarez, MD,M.Sc. UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01593020     History of Changes
Other Study ID Numbers: 2012-0167, NCI-2012-00851
Study First Received: May 3, 2012
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Early Stage Breast Cancer Not Overexpressing HER-2
Primary invasive adenocarcinoma of the breast
Paclitaxel
Taxol
Eribulin
E7389
5-Fluorouracil
5-FU
Adrucil
Efudex
Epirubicin
Ellence
Cyclophosphamide
Cytoxan
Neosar
Doxorubicin
Doxorubicin hydrochloride
Adriamycin PFS
Adriamycin RDF
Adriamycin
Rubex

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Doxorubicin
Epirubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014