Clinical trial · Interventional
3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer
A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer
NCT00095888CI-TRIAL-00008934terminatedPhase 2ClinicalTrials.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): Administratively complete.
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells
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 |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| triapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (triapine, gemcitabine hydrochloride)
- description
- Patients receive 3-AP (Triapine®) IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: triapine
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Confirmed response (complete or partial response)
- timeFrame
- Up to 6 months
- description
- Ninety five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer * Refractory metastatic disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have received 1, and only 1, prior chemotherapy regimen for metastatic disease * Patients overexpressing HER2/neu antigen must have received a prior trastuzumab (Herceptin®)-containing regimen * No known brain metastases * Hormone receptor status: * Not specified * Male or female * Performance status - ECOG 0-2 * At least 12 weeks * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance ≥ 60 mL/min * No uncontrolled congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No severe pulmonary disease requiring oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No glucose-6-phosphate dehydrogenase (G6PD) deficiency * No other uncontrolled illness * No active or ongoing infection * No history of allergic reaction attributed to compounds of similar chemical or biological composition to 3-AP (Triapine®) or other study agents * No psychiatric illness or social situation that would preclude study compliance * No other malignancy within the past 5 years * See Disease Characteristics * No concurrent immunotherapy * No concurrent routine colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * See Disease Characteristics * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior gemcitabine for metastatic disease * No other concurrent chemotherapy * More than 4 weeks since prior hormonal therapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy * Recovered from prior therapy * No concurrent antiretroviral therapy for HIV-positive patients * No other concurrent investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.