Clinical trial · Interventional
Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer
Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients
NCT00429182CI-TRIAL-00009994completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this clinical research study is to learn the relationship of high-dose chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast cancer. The study also will investigate the role of CTCs in breast cancer.
Conditions
Conditions (3)
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 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-dose chemotherapy
- description
- Carboplatin + Cyclophosphamide + Thiotepa
- interventionNames
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Thiotepa
- Procedure: Stem Cell Transplant
Primary outcomes (1)
- measure
- Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
- timeFrame
- Baseline to 1 month post AHST
- description
- Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 55 years old 2. Metastatic breast carcinoma. 3. Histological confirmation of invasive breast carcinoma 4. Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed. 5. Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR). 6. Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy. 7. Zubrod performance status 0 or 1. 8. Patients must have adequate hematological parameters (White Blood Count/WBC \>= 3,000/mm3; platelet count \>= 100,000/mm3) 9. Adequate renal function (serum creatinine \<= 1.5mg/dl) 10. Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) \<= 2 times normal). 11. Adequate cardiac function (Left ventricular ejection fraction (LVEF)\>= 50%). 12. Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)\>= 50% of predicted value). 13. Females of childbearing (women who are post-menopausal \< 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception. 14. Patients must sign an informed consent. Exclusion Criteria: 1. Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting. 2. History or presence of brain/leptomeningeal metastasis. 3. History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ. 4. Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure. 5. Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections). 6. HIV infection. 7. Pregnant or lactating women. 8. Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
References
Publications (0)
Data not yet available
No reference posted for this study.