Clinical trial · Interventional
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
NCT00496808CI-TRIAL-00047288completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Primary Objectives: * To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) * To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin (Trastuzumab) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Herceptin
- description
- 8 mg/kg intravenously (IV) Over 90 Minutes
- interventionNames
- Drug: Herceptin (Trastuzumab)
Primary outcomes (2)
- measure
- Percent Change in Proliferation as Measured by Ki-67
- timeFrame
- Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks
- description
- Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.
- measure
- Number of Participants Achieving Documented Change in Proliferation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+ positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification by fluorescence in situ hybridization (FISH) will be eligible for the study. 2. Patients must sign informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy. 3. Those patients with history of other contralateral non-invasive and invasive breast and non-breast malignancies are eligible to participate unless they have previously received a doxorubicin dose of more than 400 mg/m2. 4. All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of \> 1,500/mm3, and platelet count \> 100,000 mm3. Patients must have adequate liver function, with bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine \< 2.0 mg/dl. 5. Patients with intact primary tumors will be eligible for this study. Patients who have had their diagnostic biopsy at an outside facility but still have measurable disease on presentation will be eligible. 6. Patients with history of cardiac arrhythmia will be eligible for study after being seen by cardiology and deemed good candidates for participation. 7. Women of child bearing potential must have a negative urine or serum pregnancy test. Exclusion Criteria: 1. Patients with a current known invasive breast cancer are not eligible for this study. 2. All patients who are Her-2/neu negative will be ineligible for the study. 3. Patients with history of congestive heart failure will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.