NCT00866905

Brief Summary

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Apr 2009

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 27, 2014

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

5.3 years

First QC Date

March 19, 2009

Results QC Date

November 21, 2014

Last Update Submit

November 18, 2021

Conditions

Breast Cancer

Keywords

Breast CancerIxabepiloneIxempraCyclophosphamideCytoxanNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response Rate (pCR)

    Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.

    6 months

Secondary Outcomes (3)

  • Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain

    3 months

  • Overall Survival

    36 months

  • Disease Free Survival

    36 Months

Study Arms (1)

Ixabepilone/Cyclophosphamide

EXPERIMENTAL

Systemic Therapy followed by surgery and possible radiation therapy

Drug: IxabepiloneDrug: Cyclophosphamide

Interventions

IxabepiloneDRUG

40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles

Also known as: Systemic therapy, Ixempra
Ixabepilone/Cyclophosphamide
CyclophosphamideDRUG

600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles

Also known as: Systemic therapy, Cytoxan
Ixabepilone/Cyclophosphamide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients, age ≥18 years.
  • Histologically confirmed invasive adenocarcinoma of the breast.
  • Primary palpable disease confined to a breast and axilla on
  • physical examination. For patients without clinically suspicious
  • axillary adenopathy, the primary tumor must be larger than 2 cm
  • in diameter by physical exam or imaging studies (clinical T2-T3,
  • N0-N1, M0). For patients with clinically suspicious axillary
  • adenopathy, the primary breast tumor can be any size (clinical
  • T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
  • Patients without clearly defined palpable breast mass or axillary
  • lymph nodes but radiographically measurable tumor masses are
  • acceptable. Accepted procedures for measuring breast disease
  • are mammography, MRI, and breast ultrasound. This will need to
  • be re-evaluated after 3 cycles and prior to surgery.
  • Eastern Cooperative Oncology Group performance status (ECOG
  • +28 more criteria

You may not qualify if:

  • Inflammatory breast cancer.
  • Peripheral neuropathy (motor or sensory) ≥ grade 1 by the
  • Common Terminology Criteria for Adverse Events version 3.0
  • (CTCAE v 3.0).
  • Prior radiation that included ≥30% of major bone marrow containing
  • areas (pelvis, lumbar, spine).
  • Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of
  • the following strong CYP3A4 inhibitors: ketoconazole,
  • itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,
  • telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,
  • delavirdine, and voriconazole. Use of these agents should be
  • discontinued at least 72 hours prior to initiation of study treatment.
  • Chemotherapy within 5 years of starting study treatment except
  • for low doses of agents used for anti-inflammatory indications
  • such as rheumatoid arthritis, psoriasis, and connective tissue
  • +50 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Aventura Medical Center

Aventura, Florida, 33180, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Medical Oncology Associates of Augusta

Augusta, Georgia, 30901, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Mercy Hospital

Portland, Maine, 04101, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

National Capital Clinical Research Consortium

Bethesda, Maryland, 20817, United States

Location

St. Louis Cancer Care

Chesterfield, Missouri, 63017, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Hematology Oncology Associates of Northern NJ

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Cancer Centers of Southwest Oklahoma

Lawton, Oklahoma, 73505, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

South Texas Oncology and Hematology

San Antonio, Texas, 78258, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepiloneCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
John D. Hainsworth, MD
Organization
Sarah Cannon Research Institute
asksarah@scresearch.net
1-877-691-7274

Study Officials

  • Denise A Yardley, M.D.

    SCRI Development Innovations, LLC

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

March 19, 2009

First Posted

March 23, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

November 22, 2021

Results First Posted

November 27, 2014

Record last verified: 2021-11

Locations

US(20)