Clinical trial · Interventional
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer
- 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 chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45% by MUGA No myocardial infarction within the past 6 months No ischemic heart disease requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2 or more No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer No active unresolved infection No history of hypersensitivity reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days since prior antibiotics No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent parenteral antibiotics
References
Publications (0)
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