NCT01023477

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

Preventing Invasive Breast Neoplasia With Chloroquine (PINC) Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2009-12-02
• Last updated: 2021-06-29
• Results posted: 2021-06-29

Locations

4 sites across 1 country: United States