NCT01818999

Brief Summary

This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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 6, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 20, 2020

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

March 6, 2013

Last Update Submit

August 19, 2020

Conditions

METASTATIC BREAST CANCER

Keywords

METASTATIC BREAST CANCER

Outcome Measures

Primary Outcomes (1)

  • The effect of SBRT in combination with Ixabepilone on median progression free survival

    To evaluate the effect of SBRT in combination with Ixabepilone on median progression free survival. Progression free survival is defined as time from initiation of treatment to progressive disease or death

    5 years

Secondary Outcomes (5)

  • In-field local control and out-of field disease progression rates

    5 years

  • Safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy

    1 year

  • The duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)

    5 year

  • Overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone

    5 year

  • Generation of an immune response to tumor cells

    1 year

Study Arms (1)

arm one

EXPERIMENTAL

IXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY (SBRT)

Drug: IXABEPILONERadiation: STEREOTACTIC BODY RADIATION THERAPY

Interventions

IXABEPILONEDRUG

injection

Also known as: Ixempra
arm one
STEREOTACTIC BODY RADIATION THERAPYRADIATION

SBRT will begin between 1 and 5 weeks after the initiation of Ixabepilone. Patients will receive one, three, or five fractions.

Also known as: SBRT
arm one

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven triple negative invasive ductal or lobular metastatic breast cancer. Tumor estrogen, progesterone, and HER2 (tested by IHC or FISH) negative disease. (ER- defined as \</=1% by IHC, PR- defined as \</=1% by IHC, and HER2- by IHC 1+. If HER2 result by IHC is 2+ (equivocal), the tumor must be confirmed to be HER2- by FISH.
  • Age ≥ 18 years.
  • Patients must not have started Ixabepilone treatment more than 5 weeks prior to initiation of SBRT treatment.
  • Patients can have up to 6 sites of active extracranial disease(\</=3 in the liver = one site and \</=3 in the lung= one site) identified by CT scan, or PET/CT, within 8 weeks prior to initiation of SBRT (up to 2 contiguous vertebral metastasis will be considered a single site of disease). Maximum number of lesions treated is deemed as feasible per the treating radiation oncologist; ie: A patient with 4 right axillary lymph nodes, L1-L2 bone metastasis, 3 lung lesions, 1 left lung lesion, 2 liver lesions, and T2-T3 bone metastasis would be defined as having 6 sites of disease. Criteria to define a lesion in any location as a metastasis requiring local treatment as one of the sites for SBRT is any lesion clinically felt to be viable; defined as enlarging on CT/MRI or having persistent FDG avidity (Either SUV\>3 or increase of SUV\>20% over a 6 month interval).
  • Patients with skin nodules, skin invasion, or skin ulceration are eligible, if treatment with conventional radiation (at discretion of radiation oncologist) or surgery is planned. SBRT to skin nodules is not advised because of risk of skin necrosis.
  • Patients must have had failure of an anthracycline, a taxane and capecitabine as per FDA approved criteria.
  • Performance status of ECOG 0,1, or 2.
  • Adequate organ and marrow function as defined below:
  • leukocytes ≥ 3,000/mcL
  • absolute neutrophil count ≥ 1,500/mcL
  • platelets ≥ 100,000/mcl
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • +6 more criteria

You may not qualify if:

  • Patients may not be actively receiving any other investigational agents.
  • Patients with untreated brain metastasis (patients can have whole brain radiation or stereotactic radiation to brain prior to enrollment).
  • Patients with leptomeningeal disease.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) used in study. Patients with a history of severe reactions to Cremephor EL or its derivatives (polyoxyethylated castor oil) are ineligible as Ixabepilone contraindicated in these patients
  • Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
  • Patients with more than 6 discrete extra-cranial sites.
  • Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cancers.
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Patients must not be on concomitant CYP3A4 inhibitors or inducers (see section 4.3).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepiloneRadiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Asal Rahimi, MD

    University of Texas

    PRINCIPAL INVESTIGATOR
0

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 6, 2013

First Posted

March 27, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 20, 2020

Record last verified: 2019-01

Locations

US(1)