CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Chloroquine Standard Dose (500mg/week) +2 moredrug
Likely dose
Chloroquine Standard Dose (500mg/week)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01023477
NCT01023477Phase 2Completed

Preventing Invasive Breast Neoplasia With Chloroquine (PINC) Trial

Inova Health Care Services·interventional·Posted Dec 2, 2009·Updated Jun 29, 2021

In Brief

A Phase 2 clinical trial evaluating Chloroquine Standard Dose (500mg/week), Chloroquine Low Dose (250mg/week), and 1 other intervention for Carcinoma, Intraductal, Noninfiltrating and 2 related conditions. Completed, enrolled 12 participants across 4 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2009
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.6 years ago

Interventions

Chloroquine Standard Dose (500mg/week)drug

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

Chloroquine Low Dose (250mg/week)drug

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

Breast Biopsyprocedure

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.