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Chloroquine Standard Dose · 1 trial · 3 indications
One of the primary outcomes of this study was to measure the impact of weekly chloroquine on the amount of DCIS seen on MRI.The tumor response was evaluated by RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR The longest diameter of the target lesion or primary area of non-mass enhancement was measured by digital calipers. For one patient, the longest diameter was difficult to measure due to the presence of a significant post biopsy resolving hematoma at the biopsy site. Further correlation was made based on the extent of the pre-treatment microcalcifications and post treatment areas of non-mass enhancement.
| Arm | Type | Description |
|---|---|---|
| Chloroquine Standard Dose (500mg/week) | EXPERIMENTAL | Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month standard dose chloroquine (500 mg/week). |
| Chloroquine Low Dose (250mg/week) | EXPERIMENTAL | Patients with ER+ or ER- DCIS regardless of histologic grade will be randomly assigned to receive one month low dose chloroquine (250mg/week). |
| Name | Type | Description |
|---|---|---|
| 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 Biopsy | PROCEDURE | 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. |
Inclusion Criteria: * Patients must have a tissue diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion. * Patients with ductal carcinoma in situ undergoing either lumpectomy/radiation or mastectomy. * Patients must be female at least 1...
Chloroquine Standard Dose is being studied for the treatment of ductal carcinoma in situ (DCIS), a noninvasive form of breast cancer. It is an investigational small molecule in Phase 1 clinical development for this oncology indication.
Chloroquine Standard Dose is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR.
Chloroquine Standard Dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.
Chloroquine Standard Dose has one completed clinical trial, NCT01023477, titled 'Study of the Efficacy of Chloroquine in the Treatment of Ductal Carcinoma in Situ (The PINC Trial)'. This Phase 1 study enrolled 12 female participants in the United States.
Chloroquine Standard Dose is a specific formulation or dosing regimen of chloroquine, an established antimalarial drug. In this context, it is being repurposed as an investigational treatment for ductal carcinoma in situ.