Clinical trial · Interventional
Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer
NCT00118053CI-TRIAL-00012694terminatedPhase 2Results postedClinicalTrials.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): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
| herceptin | Biological | Trastuzumab | ALIAS |
| radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel, Carboplatin and Trastuzumab
- description
- A total of six cycles of TCH \[(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)\] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.
- interventionNames
- Biological: herceptin
- Drug: carboplatin
- Drug: docetaxel
- Procedure: conventional surgery
- Procedure: radiation therapy
Primary outcomes (1)
- measure
- Antitumor Activity as Measured by Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer, meeting 1 of the following stage criteria: * Stage IIB (T3, N0) * Stage IIIA (N0-N2) * Stage IIIB (T4, N0-2) * Stage IIIC * Inflammatory breast cancer * HER2/neu-positive disease by fluorescence in situ hybridization * Biopsy-accessible tumor * Measurable disease by physical examination or x-ray * No stage IV 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 * At least 8 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Meets 1 of the following criteria: * SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal * SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN * Bilirubin normal Renal * Creatinine normal * No pre-existing clinically significant renal disease that is not related to the malignancy Cardiovascular * Ejection fraction ≥ 50% by MUGA * No pre-existing clinically significant cardiac disease that is not related to the malignancy * No history of congestive heart failure Pulmonary * No pre-existing clinically significant pulmonary disease that is not related to the malignancy Gastrointestinal * No severe malnutrition * No intractable emesis Neurologic * No pre-existing clinically significant neurologic disease that is not related to the malignancy * No peripheral neuropathy ≥ grade 2 * No nerve damage from diabetes Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective non-hormonal contraception during and for 4 weeks after completion of study treatment * No known allergic reaction to study drugs * No active infection * No other malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other pre-existing clinically significant disease that is not related to the malignancy * No other serious or significant medical condition that would preclude study participation * No other contraindication to study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy Chemotherapy * No prior chemotherapy for the malignancy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for the malignancy Radiotherapy * No concurrent radiotherapy Surgery * No concurrent surgery for the malignancy Other * More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing products * No other concurrent investigational or commercial agents or therapies for the malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.