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Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

18 Years
Not Enrolling
Breast Cancer, Metastatic Breast Cancer

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Trial Information

Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

Inclusion Criteria:

- 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

- 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

- Premenopausal women must use contraception while receiving this treatment and during
follow-up period of 42 days.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Irene L. Wapnir

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317