Intraductal Therapy of DCIS: A Presurgery Study
Creators: name: University Of California Office Of The President
Publisher: name: University of California Office of the President
publisherIdentifier: https://ror.org/00dmfq477
publisherIdentifierScheme: ROR
Year: 2024

description: Ductal Carcinoma In Situ (DCIS), an early stage, non-invasive breast cancer, is treated with the same methods of surgery, radiation and hormone medications as more advanced forms. Historical studies show that most DCIS remains dormant and only 30-40% of cases will ever progress to invasive cancer. As more women are being diagnosed by mammography with this pre-cancer, which is not life-threatening, they are asking why they should be subjected to the more extreme treatments. The breast ducts are the microscopic pipelines that bring milk down to the nipple during breast feeding. Breast cancer starts in the epithelial cells that form the thin lining on the surface of the ducts, like tiles. With advances in technology it is possible to enter the duct system through the nipple and by procedure called ductoscopy to visualize the interior of the duct system. As an extension of this “intraductal approach” it is possible to introduce drugs or other agents into the duct system to destroy or reset the abnormal cells that are present in women bearing DCIS lesions. This novel treatment strategy may eventually save countless women from undergoing mutilating surgery and debilitating treatments.
 
 
 
 
 
 
 
 The aim of this project is to test the practicality and efficacy of a local treatment of the affected breast duct itself. We plan to use a currently approved drug, called Pegylated Liposomal Doxorubicin or PLD, by introducing it directly into the ductal system bearing DCIS lesions. In preliminary studies, our collaborators have tested this drug in rodents and humans for side effects. In rat studies, the intraductal administration of PLD can eradicate breast cancer at low doses and without the systemic side-effects seen with treatments administered via the IV (blood) route. Preliminary studies have shown that intraductal PLD is well tolerated in women, but we do not have studies demonstrating efficacy in treating DCIS. 
 
 
 
 
 
 
 
 In this study, women who have been diagnosed with DCIS on the basis of an abnormal mammogram and a biopsy (a stereotactic core) done by the radiologist will be referred to our trial. A breast PET scan and ductal lavage will be done before the treatment for a baseline. The woman will then have the duct with DCIS cannulated and a small amount of contrast material will be placed to make sure the correct duct is being treated. Then, the PLD will be introduced into the duct. Surgery will be planned for 4-6 weeks later. A day or two prior to surgery imaging tests, such as mammography and PET scans, of the breast will be repeated. The type of surgery to be done will not be affected by participation in the study. After surgery, the pathology will be studied and the women followed by their breast surgeon for at least two years, as usual. If indicated, patients will be referred for consultation with medical and/or radiation oncologists.
 
 
 
 
 
 
 
 This will be the first observational study of intraductal therapy. It can open a new era in the management of breast cancer, especially the earliest DCIS stages where women are typically over-treated.