PET Using Hormone Receptor Ligands in Breast Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country79 target enrollmentNovember 2006

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 79
Locations: 1
Primary Endpoint: To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find a way to learn the hormone receptor status of a tumor before surgery is done. By testing for the hormone receptor proteins, doctors can find out if the breast cancer uses hormones to grow. This is important since the hormone receptor status of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

June 2013

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and Female patients
•Aged 18 or older at the time of breast cancer diagnosis
•Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies.
•Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer).
•Patients who are operative candidates. Patient will have surgery to include either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible.
•Patients with bilateral breast cancer are eligible.
•Patients with metastatic cancer, provided they need surgical biopsy.
•Patients who are undergoing sentinel node mapping (day before or sameday mapping).
•Patient must sign informed consent.

Exclusion Criteria

•Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
•Patients who are pregnant or nursing
•Patients unable to tolerate PET or PET/CT
•Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis.
•Patients with non invasive breast cancer such as DCIS.
•Patients who have received prior radiation therapy to the affected breast.
•Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer.
•Patients living in a residential care or correctional facility.

Outcomes

Primary Outcomes

To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.

Time Frame: conclusion of the study

Secondary Outcomes

To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.(conclusion of the study)