Clinical trial · Interventional
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin i.d. Day 1; Normal Saline i.d. Day 15 | Drug | — | UNRESOLVED |
| Carboplatin i.d. Days 1 & 15 | Drug | — | UNRESOLVED |
| Normal Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- description
- Carboplatin infused into DCIS-involved duct on Days 1 \& 15
- interventionNames
- Drug: Carboplatin i.d. Days 1 & 15
- type
- EXPERIMENTAL
- label
- B
- description
- Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15
- interventionNames
- Drug: Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
- type
- PLACEBO_COMPARATOR
- label
- C
- description
- Normal Saline infused into DCIS-involved duct Days 1 \& 15
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLove SM, Barsky SH. Anatomy of the nipple and breast ducts revisited. Cancer. 2004 Nov 1;101(9):1947-57. doi: 10.1002/cncr.20559. PMID 15382093
- BACKGROUNDLi CI, Daling JR, Malone KE. Age-specific incidence rates of in situ breast carcinomas by histologic type, 1980 to 2001. Cancer Epidemiol Biomarkers Prev. 2005 Apr;14(4):1008-11. doi: 10.1158/1055-9965.EPI-04-0849. PMID 15824180
- BACKGROUNDKhan SA, Wiley EL, Rodriguez N, Baird C, Ramakrishnan R, Nayar R, Bryk M, Bethke KB, Staradub VL, Wolfman J, Rademaker A, Ljung BM, Morrow M. Ductal lavage findings in women with known breast cancer undergoing mastectomy. J Natl Cancer Inst. 2004 Oct 20;96(20):1510-7. doi: 10.1093/jnci/djh283. PMID 15494601