Clinical Trial: Study of the Efficacy of Chloroquine in the Treatment of Ductal Carcinoma in Situ (The PINC Trial)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preventing Invasive Breast Neoplasia With Chloroquine (PINC) Trial

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 Summary: 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.
Sponsor: Inova Health Care Services

Current Primary Outcome: Tumor response evaluated by RECIST criteria as measured by breast MRI. [ Time Frame: Immediately preceding study drug treatment and again after treatment prior to surgery. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the safety and dosing efficacy of chloroquine in the treatment of patients with DCIS. [ Time Frame: Continually ]
  • Evaluate the effect of therapy on the progenitor cell yield and invasive capacity ex vivo. [ Time Frame: At the time of breast biopsy and again at time of surgery. ]
  • Evaluate the effect of treatment on the proteomic and molecular cytogenetic profiles of the DCIS lesions. [ Time Frame: At the time of breast biopsy and again at the time of surgery. ]


Original Secondary Outcome: Evaluate the safety of combined chloroquine and tamoxifen therapy (relevant only for combined chloroquine and tamoxifen arm). [ Time Frame: Continually ]

Information By: Inova Health Care Services

Dates:
Date Received: December 1, 2009
Date Started: December 2009
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017