Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

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.

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