Clinical trial · Interventional
Neoadjuvant Herceptin in Patients With Breast Cancer
A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer
NCT00133796CI-TRIAL-00025826terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed to accrual 4/19/2006 / Study doesn't qualify for reporting.
Summary
Brief summary (as posted)
The purposes of this study are to better understand how Herceptin causes tumors to become smaller and to find out how effective Herceptin, together with chemotherapy, is in treating advanced breast cancer.
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 |
|---|---|---|---|
| BREAST CANCER | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Heceptin
- description
- Herceptin administered to enrolled subjects
- interventionNames
- Drug: Herceptin
Primary outcomes (1)
- measure
- The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer
- timeFrame
- 1 year
- description
- A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin
Secondary outcomes (1)
- measure
- To determine clinical response to therapy with Herceptin and Taxotere
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must be female. * Informed consent must be signed. * Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size \> 4 cm, and/or are deemed surgically inoperable. * Her2/neu overexpressing tumors defined as HercepTest score of 3+, or \>/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive. * Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential. * Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal. * Performance status (World Health Organization \[WHO\] scale) \< 2 and life expectancy \> 6 months. * Age \> 18. * No metastatic disease without concomitant primary breast cancer. * No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Exclusion Criteria: * Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. * Severe underlying chronic illness or disease. * Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) \< 50%. * Patients on other investigational drugs while on study. * Severe or uncontrolled hypertension defined as blood pressure (BP) \> 180/100 on three separate occasions. * History of congestive heart failure. * History of coronary arterial disease.
References
Publications (0)
Data not yet available
No reference posted for this study.