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

NCT01593020 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2012-0167NCI-2012-00851
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  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.

  4 -6 weeks from last dose of FAC/FEC-regimen.

Secondary Outcomes (2)

• 5 Year Event Free Survival (EFS)

  from start of treatment, up to 5 years

• Overall Survival (OS)

  from start of treatment, up to 5 years

Study Arms (2)

Paclitaxel + FEC or FAC Group

EXPERIMENTAL

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; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Doxorubicin

Eribulin + FEC or FAC Group

EXPERIMENTAL

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; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Doxorubicin

Interventions

Paclitaxel DRUG

80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.

Also known as: Taxol

Paclitaxel + FEC or FAC Group

Eribulin DRUG

1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.

Also known as: E7389

Eribulin + FEC or FAC Group

5-Fluorouracil DRUG

500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

Also known as: 5-FU, Adrucil, Efudex

Eribulin + FEC or FAC Group; Paclitaxel + FEC or FAC Group

Epirubicin DRUG

100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

Also known as: Ellence

Eribulin + FEC or FAC Group; Paclitaxel + FEC or FAC Group

Cyclophosphamide DRUG

500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

Also known as: Cytoxan, Neosar

Eribulin + FEC or FAC Group; Paclitaxel + FEC or FAC Group

Doxorubicin DRUG

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.

Also known as: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF, Adriamycin, Rubex

Eribulin + FEC or FAC Group; Paclitaxel + FEC or FAC Group

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Histologically confirmed primary invasive adenocarcinoma of the breast.
• Clinical stage breast cancer T2-3, N0-3, M0
• 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).
• 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.
• Karnofsky performance status (KPS) of 80 - 100
• The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Baseline MUGA or echocardiogram scans with LVEF of \> 50%.
• Normal PTT and either INR or PT \< 1.5 x ULN.
• Men or women 18 years of age or older.
• 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.
• Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.

You may not qualify if:

• Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
• 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.
• Absolute neutrophils count (ANC) \< 1500/mm\^3
• Total bilirubin \> 1.5 times the upper limit of normal (ULN)
• AST or ALT \> 2.5 times the upper limit of normal (ULN)
• Platelets \< 100,000/mm\^3.
• Serum creatinine \> 1.5 x ULN or creatinine clearance \< 60 mL/min (measured or calculated by Cockcroft-Galt method)
• Evidence of metastatic breast cancer following a standard tumor staging work-up
• Evidence of inflammatory breast cancer.
• Evidence of any grade 2 sensory or motor neuropathy.
• Known human immunodeficiency viral (HIV) infection
• Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.
• Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; eribulin; Fluorouracil; Epirubicin; Cyclophosphamide; Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Valero Vicente, Professor, Breast Medical Oncology
• Organization: UT MD Anderson Cancer Center

vvalero@mdanderson.org

(713) 563-0751

Study Officials

• Vicente Valero, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: August 3, 2012
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: September 22, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-08

Locations

US (1)