Eligible patients: We are recruiting women who were recently diagnosed with metastatic (Stage IV) lobular breast cancer (either as a recurrence after breast cancer in the breast was treated, or as a completely new diagnosis of ILC) who have not yet started treatment and are planning to start either an aromatase inhibitors or fulvestrant. Additional eligibility criteria can be found here.

Description of Trial/Summary: Invasive lobular breast cancer (ILC) is the second most common histological (i.e. microscopic structure of the tissue) subtype of breast cancer. In 2024, ILC will affect up to 40,000 patients in the United States, and if considered an independent malignancy is the 6th most frequent cancer in women. The hallmark of ILC is loss of the cell-to-cell connection molecular, E-cadherin, which results in infiltrative, single-file growth of the cancer cells. This creates difficulties with using conventional imaging techniques like mammography and ultrasound for the diagnosis of ILC in the breast and CT’s and PET scans to monitor how patients treated for ILC respond to treatment once the cancer has spread. We hypothesize that an alternative method called circulating tumor DNA (ctDNA), which can be obtained from a blood draw, can be used to monitor response. Since most ILC’s are positive for the estrogen receptor, they are generally treated with estrogen blocking therapy. The LBC-Monitor study is assessing the ability of the SIgnatera ctDNA blood test to predict how patients with newly diagnosed metastatic ILC respond to first line estrogen blocking treatment either with aromatase inhibitors or fulvestrant. We will ask women to provide a blood sample before starting treatment, and then after 4, 8 and 12 weeks of being on estrogen blocking therapy. We will also obtain imaging before starting treatment after 12 weeks of therapy to compare how the SIgnatera test performs against imaging. We hope that in the future, minimally invasive blood tests may replace imaging tests in the monitoring of patients with metastatic ILC and may open opportunities for further research studies. 

Principal Investigator: Julia Foldi, MD, PhD

Trial Location: Magee Women’s Hospital of UPMC, Pittsburgh, PA 15213

More information /Trial Contact: 

Lucia Borasso, BA
412-641-3304
borrlm@upmc.edu 

Study Contact Backup

Kelsey Mitch, RN
412-641-2357
adamikka2@upmc.edu 

For more information: https://clinicaltrials.gov/study/NCT06666439?titles=lobular&aggFilters=status:rec&rank=8