Clinical trial · Interventional
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer
NCT00191451CI-TRIAL-00002798completedPhase 2Results 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)
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Herceptin | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- HER2+
- description
- Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin.
- interventionNames
- Drug: Gemcitabine
- Drug: Carboplatin
- Drug: Herceptin
- type
- EXPERIMENTAL
- label
- HER2- (Taxane-)
- description
- Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients).
- interventionNames
- Drug: Gemcitabine
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- HER2- (Taxane+)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of metastatic breast cancer 2. Able to visit the doctor's office at least every 14 days during the actual treatment 3. Able to care for yourself, even if you cannot work or participate in other normal activities 4. Your blood results must be adequate for therapy. 5. If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug. Exclusion Criteria: 1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer. 2. Be pregnant or breastfeeding 3. Have cancer to the brain and has not been treated 4. Have another active cancer besides breast cancer 5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
References
Publications (0)
Data not yet available
No reference posted for this study.