Clinical trial · Interventional
Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
Herceptin and Paclitaxel in Locally Advanced Breast Cancer With Her-2 Overexpression
- 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)
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may be an effective treatment for locally advanced breast cancer. PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus paclitaxel followed by surgery and combination chemotherapy in treating women who have locally 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Palpable primary breast cancer at least 3 cm (T2 at least 3 cm, T3-T4, any N) No distant metastasis (M0) HER2 overexpression of 2+ or 3+ by immunohistochemistry performed on core biopsy specimen using the Dako Hercep Test Hormone receptor status: Status known PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Premenopausal or postmenopausal Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Ejection fraction normal by MUGA No history of congestive heart failure, myocardial infarction, arrhythmia, or ischemic heart disease Other: No other prior malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective barrier contraception during and for 2 months after study No pre-existing clinically significant peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
References
Publications (0)
Data not yet available