Clinical trial · Interventional
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies
NCT02470819CI-TRIAL-00035668withdrawnN/AClinicalTrials.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): Investigator elected to end the study
Summary
Brief summary (as posted)
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
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 |
|---|---|---|---|
| Advanced Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
| Breast Tumor | Breast Neoplasm | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic profiling | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targeted Therapy
- description
- Those who will receive targeted therapy based on their genetic profiling
- interventionNames
- Genetic: Genetic profiling
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 4 months
- description
- Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.
Secondary outcomes (1)
- measure
- Tumor assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy of \>3 months * Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease * Age greater than or equal to 18 years * ECOG performance status of 0-1 * Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional * Have failed or unable to tolerate previous treatment regimen * Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy) Exclusion Criteria: * Metastatic lesions that are not accessible to biopsy * Symptomatic CNS metastasis * Previous history of another malignancy within 5 years of study entry * Uncontrolled concurrent illness * Known HIV, HBB, and/or HCV infection * Pregnant or breast feeding or childbearing potential and not using adequate birth control
References
Publications (0)
Data not yet available
No reference posted for this study.