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Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer


Inclusion Criteria:



- Registered patient at MSKCC

- Age ≥18 years

- Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or
with evidence of gene amplification (>2.0) by fluorescence in situ hybridization
(FISH))

- Measurable or evaluable disease

- Currently taking or about to commence treatment with trastuzumab at a dosing schedule
of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care

- Karnofsky Performance Score ≥ 60

- Signed informed consent

Exclusion Criteria:

- Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in
discontinuation of trastuzumab therapy

- Claustrophobia/pain leading to inability to lie still for the duration of the
scanning procedure.

- Pregnancy Test to be performed on female patients of childbearing potential within
24hrs before administration of radioactive material.

- Inability to provide written informed consent.

- Patients with liver metastases as the only site of distant disease

- Patients with known sensitivity or contraindication to Herceptin.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Jorge Carrasquillo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-134

NCT ID:

NCT00605397

Start Date:

January 2007

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Cu-64 LABELED TRASTUZUMAB
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021