Clinical trial · Observational
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
NCT00897702CI-TRIAL-00101795completedClinicalTrials.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 purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy stops working. However, we do not know if the same molecules change in patients. This study is being done to see if they do change. If we learn more about how patients become resistant, we may be able to offer better treatment in the future.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| Blood draw | Other | — | UNRESOLVED |
| histopathologic examination | Procedure | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To look for mutations in druggable oncogenic pathways in tumors progressing on anti-HER2 therapy or hormonal therapy
- timeFrame
- 3 years
- measure
- To characterize the activity of the PI3K signaling pathway in progressive breast tumors using proteomic methods
- timeFrame
- 3 years
- measure
- To develop new laboratory models of treatment refractory breast cancer from human tumor specimens
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- To look for mutations in druggable oncogenic pathways in tumor progressing on breast cancer targeted therapies
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: All patients: * Diagnosed with breast cancer. * Patient must be able to consent to a biopsy * Patient must be able to safely undergo a secondary biopsy, if needed. Cohort 1 * Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced. * Evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis). * Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (\>1.9 gene copy number) or IHC 3+. Cohort 2 * Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression. Cohort 3 * Patients not eligible for Cohorts 1 or 2. Exclusion Criteria: * Patients who are unable to consent to a biopsy. * Patients for whom a repeat biopsy would be medically unsafe
References
Publications (0)
Data not yet available
No reference posted for this study.