Clinical trial NCT00647790: Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer
Official title: PET Using Hormone Receptor Ligands in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: PET imaging
invasive breast cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-04-01
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Clinic

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.


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.

Primary outcomes:
measure: To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary Gemignani, MD
role: PRINCIPAL_INVESTIGATOR
References: