Clinical trial · Interventional
Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer
Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant (Pilot Phase II)
NCT00020722CI-TRIAL-00020939terminatedPhase 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): Lack of funding to continue study.
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 chemotherapy with peripheral stem cell transplantation plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy followed by peripheral stem cell transplantation plus biological therapy works in treating women with stage IV 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 |
|---|---|---|---|
| Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC) | Drug | — | UNRESOLVED |
| Ifosfamide, carboplatin, and etoposide (ICE) regimen | Drug | — | UNRESOLVED |
| Leukapheresis | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation (PBSCT) | Procedure | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- therapeutic autologous lymphocytes
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Drug: Ifosfamide, carboplatin, and etoposide (ICE) regimen
- Drug: Cyclophosphamide, Thiotepa, Carboplatin (CTC) or STAMP V (CTC)
- Procedure: Leukapheresis
- Procedure: peripheral blood stem cell transplantation (PBSCT)
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- Length of time from day of transplant until recurrence or relapse.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Length of time from day of transplant until death.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Women with histologically documented metastatic carcinoma of the breast * Bilateral disease allowed * Concurrent intraductal or lobular carcinoma in situ allowed * Measurable or evaluable recurrent metastatic disease (stage IV) documented by radiograph, CT scan, nuclear medicine scan, or physical exam * Biopsy of recurrent site(s) recommended but not required * Nonmeasurable disease allowed if tumor or metastatic disease has been previously removed or successfully treated * 0 to 3+ HER2 amplification, as determined by FISH * No clinical evidence of active brain metastases * Patients with treated brain metastases (i.e., those who have received definitive radiation, chemotherapy, and/or underwent surgery) and are stable are eligible * Hormone receptor status: * Estrogen or progesterone receptor positive or negative PATIENT CHARACTERISTICS: * Menopausal status not specified * Karnofsky performance status 70-100% OR ECOG performance status 0-2 * Life expectancy at least 3 months * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 50,000/mm\^3 * Hemoglobin greater than 8 g/dL * Bilirubin less than 1.5 times normal * AST, ALT, and alkaline phosphatase \< 5 times upper normal * Creatinine less than 1.8 mg/dL * Creatinine clearance at least 60 mL/min * BUN less than 1.5 times normal * No myocardial infarction (MI) within the past year * No history of MI (\> 1 year ago) with current coronary symptoms requiring medication * No current history of angina/coronary symptoms requiring medication * No clinical evidence of congestive heart failure requiring medical management * No significant congestive heart failure * No other uncontrolled or significant cardiovascular disease * Ejection fraction at least 45% at rest by MUGA * Systolic BP \< 130 mm Hg and diastolic BP \< 80 mm Hg * BP must be controlled to meet the standard by anti-hypertensive medications for at least 7 days prior to the first infusion * PFT-FEV\_1 at least 50% predicted * DLCO2 at least 50% predicted * FVC at least 50% predicted * No other malignancy within the past 3 years * No other serious medical or psychiatric illness that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior chemotherapy regimens allowed, including prior treatment on protocol WSU-2006-130 * Prior vaccine therapy on protocol WSU-2006-130 allowed * More than 4 weeks to leukapheresis since prior hormonal therapy * No radiation to the axial skeleton within 4 weeks of leukapheresis * No concurrent hormonal therapy for breast cancer * Hormones administered for non-disease-related condition (e.g. insulin for diabetes) allowed * Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed
References
Publications (0)
Data not yet available
No reference posted for this study.