Clinical trial · Interventional
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer
PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel added to a regimen of high-dose chemotherapy with cyclophosphamide and carboplatin followed by peripheral stem cell transplantation in treating women with 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| mesna | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically diagnosed, stage IV adenocarcinoma of the breast Previously untreated or prior adjuvant chemotherapy only CR or PR following 3-5 courses of induction chemotherapy for current diagnosis with one of the following: Cyclophosphamide/doxorubicin Cyclophosphamide/methotrexate/fluorouracil Cyclophosphamide/mitoxantrone No active CNS metastases on CT or MRI Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Women Menopausal status: Pre- or postmenopausal Performance status: ECOG 0-2 Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction greater than 50% on MUGA or echocardiogram No abnormal cardiac conduction on EKG, i.e.: No second- or third-degree heart block No bundle-branch block No arrhythmia except: Supraventricular sinus tachycardia Occasional premature atrial or ventricular contractions Pulmonary: DLCO greater than 60% of predicted Other: No preexisting peripheral neuropathy No HIV antibody No history of second malignancy within 5 years except: Nonmelanomatous skin cancer Cervical carcinoma in situ No pregnant or nursing women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Hematologically recovered from prior chemotherapy Endocrine therapy: Failure on 1 prior hormonal regimen required for ER-positive disease (greater than 10 femtomoles) unless visceral metastatic crisis requires immediate chemotherapy Radiotherapy: Not specified Surgery: Not specified
References
Publications (0)
Data not yet available