Ductal Carcinoma In Situ
Conditions
Keywords
Ductal Carcinoma In Situ, DCIS, Breast Cancer, Carboplatin, Intraductal
Brief summary
The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.
Detailed description
This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core biopsy will receive intraductal administration of either carboplatin or normal saline (NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm) will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1 and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from diagnosis). The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the resection specimen will be assessed. Venous blood samples will be collected for carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following intraductal infusions on Days 1 and 15.
Interventions
DRUGCarboplatin i.d. Days 1 & 15
Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 & 15
DRUGCarboplatin i.d. Day 1; Normal Saline i.d. Day 15
Carboplatin 10 mg/ml, 10 ml (100 mg) i.d. DCIS duct on Day 1 Normal Saline, 10 ml i.d. DCIS duct on Day 15
DRUGNormal Saline
Normal Saline, 10 ml, i.d. on Days 1 and 15
Sponsors
Windy Hill Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 18 years of age or older * Scheduled to undergo surgical resection in 2 weeks or longer * Pathological diagnosis of DCIS requiring surgical resection * DCIS diagnosed with core biopsy * Mammogram within 6 weeks of diagnosis * Adequate organ function as defined by the following criteria: Absolute neutrophil count (ANC) ≥ 1500/μl, Platelets ≥ 140,000/μl,Hemoglobin ≥ 12.0 g/dl, Creatinine \< 2.0 mg/dl \- Able to sign informed consent
Exclusion criteria
* Current diagnosis of invasive or inflammatory breast carcinoma * DCIS with microinvasion on histology on core needle biopsy * Palpable mass * Mass on mammography * Concurrent anti-cancer therapy * Prior exposure to carboplatin (related to current or past diagnosis) * Prior radiation to the breast or chest wall * Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple * Presence of breast implants * Presence of ulcerating or fungal skin lesions or infection of the breasts * Pregnant or lactating * Impaired cardiac function or history of cardiac problems * Poor nutritional state (as determined by clinician) * Presence of serious infection * Scheduled for intraoperative radiation of breast or chest wall * Allergies to lidocaine or marcaine * Allergies to imaging dyes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion | 2 to 4 weeks following the Day 15 intraductal infusion |
Secondary
| Measure | Time frame |
|---|---|
| characterize i.d. carboplatin pharmacokinetics | 4 -8 weeks |
| characterize clinical extent of disease on MRI and/or mammogram | 2 - 4 weeks |
| characterize the histopathological assessment of DCIS | 4 - 10 weeks |
| Biomarker measurement of Ki-67, TUNEL and G-actin | 4 - 8 weeks |
Countries
United States
Contacts
Primary ContactJane Doerr, RN, MSN
Backup ContactAndy Dorr, MD
Outcome results
None listed