This study screens for edema and breast cancer related lymphedema in patients who are undergoing targeted therapy for breast cancer that is at early stage or has spread to other places in the body (metastatic). This study aims to see whether there is a higher rate of edema/breast cancer related lymphedema onset in patients undergoing targeted therapy for both early and metastatic breast cancer compared to the general population of patients treated for breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05142800.
PRIMARY OBJECTIVES:
I. To screen for edema and breast cancer-related lymphedema (BCRL) in patients undergoing targeted therapy (for early or metastatic breast cancer) using volumetric measurements obtained with a perometer +/-a SOZOdevice, as well as symptoms, before the start of the therapy regimen and throughout the course of treatment.
II. To monitor the progression of edema/BCRL and the responsiveness to treatment of BCRL in patients undergoing therapy with PI3K/mTOR/CDK4/6 inhibitors.
III. To understand the impact of therapeutic drugs targeting the phosphoinoside-3-kinase/mechanistic target of rapamycin (PI3K/mTOR) or the CDK4/6 cell signaling mechanism on the incidence and severity of edema/BCRL.
IV. To evaluate the incidence and severity of edema/BCRL in patients undergoing treatment with PI3K/mTOR/CDK4/6 inhibitors for metastatic disease as compared to those being treated for early breast cancer.
OUTLINE:
Patients undergo measurement of arm volume by the perometer and complete questionnaires before first dose of drug therapy or shortly after initiating drug treatment, throughout drug treatment, and then for up to 6 months after treatment has finished.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAlphonse G. Taghian
