Conditions: Carcinoma, Intraductal, Noninfiltrating DCIS Ductal Carcinoma In Situ
Keywords: Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma In Situ DCIS Carcinoma, Intraductal Breast Cancer Breast Tumors chloroquine autophagy Autophagic Cell Death Autophagocytosis Programmed Cell Death, Type II Autophagy, Cellular Autophagic Programmed Cell Death
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the hypothesis that chloroquine will reduce the ability of ductal carcinoma in situ (DCIS) to survive and spread. Participants will receive either chloroquine standard dose (500mg/week) or chloroquine low dose (250mg/week) for 1 month prior to surgical removal of the tumor.

Detailed description:
The purpose of this study is to test the hypothesis that inhibiting the autophagy pathway in DCIS will reduce the capacity of DCIS to survive and invade. The study will examine the safety and effectiveness of neoadjuvant chloroquine administration for a one month period to patients with low, intermediate grade, or high grade DCIS. We will evaluate whether this treatment will reduce the capacity of DCIS neoplastic cells, existing within the duct, to survive, induce lesion regression, and kill the invasive DCIS progenitor cells.

Arms:
arm 1: Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week). arm 2: Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week).

Interventions: intervention 1: Chloroquine Standard Dose (500mg/week) intervention 2: Chloroquine Low Dose (250mg/week) intervention 3: Breast Biopsy
Intervention descriptions: intervention 1: Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion. intervention 2: Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion. intervention 3: Patients diagnosed with DCIS will undergo a breast biopsy prior to the start of study treatment. This biopsy is entirely voluntary and is not required to remain in the study. The biopsy will allow researchers to study the tissue for biomarkers and to determine how the DCIS tissue changes during treatment. Additional samples of the DCIS tissue will be collected at the time of surgery.

Protocol document: