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

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.

Conditions

• Carcinoma, Intraductal, Noninfiltrating
• DCIS
• Ductal Carcinoma In Situ

Interventions

DRUG

Chloroquine Standard Dose (500mg/week)

Patients will receive chloroquine (500 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.

DRUG

Chloroquine Low Dose (250mg/week)

Patients will receive chloroquine (250 mg/once a week) for 1 month prior to surgical removal of the DCIS lesion.

PROCEDURE

Breast Biopsy

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.

Sponsors & Collaborators

• George Mason University

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• U.S. Army Medical Research and Development Command

  collaborator FED

• Inova Health Care Services

  lead OTHER

Principal Investigators

• Kirsten H Edmiston, MD, FACS · Inova Fairfax Hospital Cancer Center

• Priscilla McAuliffe, MD, PhD · Magee-Women's Hospital of UPMC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• United States

Study Locations