NCT01360177

Brief Summary

This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS \[Na+I- symporter, sodium iodide symporter\] and demonstrate radioiodide uptake on 124I PET/CT scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25 to 100 mCi.

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 Jul 2010

Typical duration for not_applicable breast-cancer

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withdrawn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

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.4 years

First QC Date

April 18, 2011

Last Update Submit

July 18, 2016

Conditions

Breast CancerMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response

    * cCR (complete clinical response) = disappearance of all tumor * cPR (clinical partial response) = \>=30% decrease sum of longest target lesion diameters * cPD (progressive disease) = \>=20% increase sum of longest target lesion diameters. * cSD (stable disease) = small changes that do not meet these criteria

    6 WEEKS POST-TREATMENT

Secondary Outcomes (1)

  • Non target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response

    EVALUATED AT 6 WEEKS

Study Arms (1)

Radioactive Iodide and PET/CT

EXPERIMENTAL
Procedure: 124 PET/CT imagingDrug: Na134IDrug: Tri-iodothyronine

Interventions

124 PET/CT imagingPROCEDURE

Standard of Care

Also known as: Positron emission tomography - computed tomography
Radioactive Iodide and PET/CT
Na134IDRUG

25 to 150 mCi

Also known as: GE Healthcare
Radioactive Iodide and PET/CT
Tri-iodothyronineDRUG

75 ug/8hr x 4 weeks; oral

Also known as: T3
Radioactive Iodide and PET/CT

Eligibility Criteria

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

You may qualify if:

  • Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.
  • Patients who are 18 years of age or older.
  • Patients must have a life expectancy of at least 3 months.
  • I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.
  • I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.
  • Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.
  • Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.
  • Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.
  • Thyroid stimulating hormone (TSH) must be \< 0.4 uIU/mL.
  • White blood cell count \>= 1,500 and platelet count \>= 40,000
  • Women receiving thyroid hormone supplements and methimazole.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.

You may not qualify if:

  • Stage 0-II breast cancer.
  • Pregnant or nursing women.
  • Not able to sign informed consent.
  • Untreated psychiatric disorder.
  • Women who have not had I124 PET/CT scan and dosimetry calculations.
  • Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.
  • Received chemotherapy less than 4 weeks before.
  • History of thyroid cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Irene L. Wapnir

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2011

First Posted

May 25, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

US(1)