Abstract: The invention provides devices, kits and methods for delivering an agent to a breast milk duct. Intraductal agent delivery provides an opportunity to treat a breast condition locally and avoid the pitfalls of systemic drug delivery for a local condition. Time-released agents delivered into the ducts using an intraductal device or formulation reduces the frequency of intraductal administration required for desired efficacy over time. The methods include methods of treating a breast condition, including the conditions of cancer or precancer.

Abstract: The invention is to methods for identifying asymptomatic patients who have a likelihood of benefiting from administration of an estrogen activity modulator for risk reduction or therapeutic treatment of breast cancer, methods for reducing risk or therapeutically treating these asymptomatic patients, and methods for monitoring the treatments.

Abstract: Apparatus, methods and kits for simultaneous delivery of a fluid or other substance to two or more breast milk ducts are provided. The fluid can be delivered for a variety of purposes including lavage of the ducts and administering an agent for therapeutic, prophylactic, or diagnostic purposes.

Abstract: Methods, systems, and kits for treating breast tissue rely on transferring energy to or from cells lining an individual breast duct. Energy can be introduced into the breast duct, e.g., by filling the duct with an electrically conductive medium and applying radiofrequency energy to the medium. Other energy forms could also be used, such as light, ultrasound, radiation, microwave energy, heat, cold, direct current, and the like. By treating individual breast ducts, cancerous and pre-cancerous conditions originating in the duct can be effectively treated.

Abstract: Differentiating breast ducts for cancer risk status is a key element in a procedure to screen women for breast cancer. The 6 to 9 breast ducts on the human breast can be differentiated to identify those of higher risk for cancer. The higher risk ducts merit access and analysis of the ductal fluid and monitoring and/or treatment.

Abstract: A sample for diagnosis of breast cancer can be prepared by isolating a ductal fluid sample from one duct of a breast of a patient. The isolated ductal fluid is not mixed with ductal fluid from any other duct of the breast. Generally the target duct is not spontaneously discharging. The isolated ductal fluid sample can be examined to determine the presence or absence of a marker associated with cancer or pre-cancer. An isolated ductal fluid sample not mixed with ductal fluid from any other duct of the breast permits identification of the duct which is diseased and provides increased sensitivity for existing diagnostic and analytic techniques.

Abstract: The present invention relates to an apparatus and method for collecting and analyzing a biological specimen such as ductal fluid from a mammary gland duct. The biological specimen is contacted with a solid phase and cell markers that may be indicative of breast cancer or other lesions may be identified. Early diagnosis of breast cancer may be achieved as well as therapeutic or prognostic factors may be identified.

Abstract: The invention is to methods for screening women for breast cancer and precancer by determining a level of an estrogen-related marker. The invention further provides methods of treating such patients identified as having one or more abnormal ductal epithelial cells and an estrogen-related marker. The invention provides methods for screening patient for hormone replacement therapy (HRT), and of monitoring such patients once they begin HRT. The invention provides methods of treating peri-, menopausal or postmenopausal women for both cancer risk reduction and menopausal symptoms (or other conditions related to lowered systemic estrogen levels). The invention also provides kits for the screening, monitoring, and treating methods described.

Abstract: The present invention relates to an apparatus and method for administering a radioactive tracer dye and an inhibitor compound into a breast duct of the breast and imaging the breast for breast lesions. The radioactive tracer dye may be Tc-99m sestamibi and the inhibitor compound may inhibit a P-glycoprotein pump in tumor cells. When the inhibitor compound inhibits the P-glycoprotein pump in tumor cells, the radioactive tracer dye may effectively accumulate in tumor cells and improve the sensitivity of nuclear imaging of breast lesions.

Abstract: The invention provides methods, devices and systems for collecting breast ductal fluid comprising cellular material and other useful markers for analysis. The methods typically comprise access of at least one breast duct and collecting materials from that duct separate from all other ducts in the breast. The devices comprise ductal access devices that provide the opportunity to collect fluid from a single duct separate from all the other ducts in the breast. The systems employ the methods and devices that used together provide systems for analysis of a breast condition in a patient specific to accessed breast ducts. The methods, devices and systems are particularly useful for identification of breast precancer or cancer in within the patient.

Abstract: The present invention relates to an apparatus and method for administering diagnostic and therapeutic agents into a breast duct. A thymidine kinase vector may be administered into a breast duct in conjunction with an acycloguanidine compound for enhanced imaging on PET scanning of the breast to detect breast lesions. The thymidine kinase phosphoraylates the acycloguanidine compound to enhance visibility of lesions on PET scan. An acyclic nucleoside compound may be administered into the breast duct to form phosphorylated adducts that phosphorylate DNA and kill thymidine kinase expressing cancer cells.

Abstract: The invention is a gel composition for delivery to a breast milk duct prior to surgical excision of breast tissue including cancerous lesions. The invention also provides methods of mapping all or nearly all of a breast milk duct prior to surgical excision of breast tissue, and method of identifying part or all of a breast duct or ducts as a surgical aide to a breast surgeon. Kits to support these methods and including these compositions are also provided.

Abstract: A sample for diagnosis of breast cancer can be prepared by isolating a ductal fluid sample from one duct of a breast of a patient. The isolated ductal fluid is not mixed with ductal fluid from any other duct of the breast. Generally the target duct is not spontaneously discharging. The isolated ductal fluid sample can be examined to determine the presence or absence of a marker associated with cancer or pre-cancer. An isolated ductal fluid sample not mixed with ductal fluid from any other duct of the breast permits identification of the duct which is diseased and provides increased sensitivity for existing diagnostic and analytic techniques.

Abstract: The invention is to methods for screening women for breast cancer and precancer by determining a level of an estrogen-related marker. The invention further provides methods of treating such patients identified as having one or more abnormal ductal epithelial cells and an estrogen-related marker. The invention provides methods for screening patient for hormone replacement therapy (HRT), and of monitoring such patients once they begin HRT. The invention provides methods of treating peri-, menopausal or postmenopausal women for both cancer risk reduction and menopausal symptoms (or other conditions related to lowered systemic estrogen levels). The invention also provides kits for the screening, monitoring, and treating methods described.

Abstract: Differentiating breast ducts for cancer risk status is a key element in a procedure to screen women for breast cancer. The 6 to 9 breast ducts on the human breast can be differentiated to identify those of higher risk for cancer. The higher risk ducts merit access and analysis of the ductal fluid and monitoring and/or treatment.

Abstract: The invention is a gel composition for delivery to a breast milk duct prior to surgical excision of breast tissue including cancerous lesions. The invention also provides methods of mapping all or nearly all of a breast milk duct prior to surgical excision of breast tissue, and method of identifying part or all of a breast duct or ducts as a surgical aide to a breast surgeon. Kits to support these methods and including these compositions are also provided.

Abstract: Apparatus, methods and kits for simultaneous delivery of a fluid or other substance to two or more breast milk ducts are provided. The fluid can be delivered for a variety of purposes including lavage of the ducts and administering an agent for therapeutic, prophylactic, or diagnostic purposes.

Abstract: The disclosure describes methods of identifying and treating premalignant and malignant breast cancer, and systems and kits for the same. The diagnostic methods comprise intraductal administration of agents that can clear in the body comprising a targeting molecule either alone acting as an identifying agent, or coupled to an identifying agent; the therapeutic methods comprise intraductal administration of agents that can clear n the body comprising a targeting molecule coupled to a therapeutic agent or a targeting molecule having also therapeutic activity.

Abstract: The invention provides methods of identifying premalignant and malignant breast cancer, determining lymph node involvement in patients diagnosed with premalignant and malignant breast cancer growths, and methods of treating premalignant and malignant breast cancer. The diagnostic and methods comprise intraductal administration of a targeting molecule either alone acting as an identifying agent, or coupled to an identifying agent; the therapeutic methods comprise intraductal administration of a targeting molecule coupled to a therapeutic agent or administration of a targeting molecule having therapeutic activity in and of itself.

Abstract: The invention provides devices, kits and methods for delivering an agent to a breast milk duct. Intraductal agent delivery provides an opportunity to treat a breast condition locally and avoid the pitfalls of systemic drug delivery for a local condition. Time-released agents delivered into the ducts using an intraductal device or formulation reduces the frequency of intraductal administration required for desired efficacy over time. The methods include methods of treating a breast condition, including the conditions of cancer or precancer.