Clinical trial · Observational
Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
- 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)
This is a multicenter translational study to understand therapeutic resistance in patients undergoing standard chemotherapy for triple negative breast cancer. In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and banked before the start of chemotherapy and after the completion of the treatment (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples from metastatic lesions will be collected and banked before the start of chemotherapy and at the time of tumor progression. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment. All samples will be stored in the Biological Resource Repository.
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 |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle core biopsies | Procedure | — | UNRESOLVED |
| Needle core biopsies of metastatic lesion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neoadjuvant setting
- interventionNames
- Procedure: Needle core biopsies
- label
- Metastatic setting
- interventionNames
- Procedure: Needle core biopsies of metastatic lesion
Primary outcomes (1)
- measure
- Biomarkers changes in patients that have been exposed to chemotherapy
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- Create a unique bank of biospecimens from patients with triple negative breast tumors comprising tumor material and plasma collected in a specific and well defined clinical context.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Neoadjuvant setting 1. Histologically confirmed diagnosis of adenocarcinoma of the breast 2. Patient candidate for neoadjuvant chemotherapy (taxane-based) 3. Triple negative (ERnegative, PRnegative and Her2negative as defined by local standards) 4. Normal coagulation profile; including INR/ PTT ≤ 1.5 x ULN. 5. ECOG 0,1 or 2 6. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained. 7. Able to adhere to the study visit schedule and other protocol requirements. Metastatic setting 1. Patients with histologically confirmed primary adenocarcinoma of the breast 2. Metastatic (stage IV) disease at initial diagnosis or following previous diagnosis of primary breast cancer 3. At least one metastatic site accessible for biopsy. 4. ER-negative, PgR negative and HER2 negative as per local standards 5. Scheduled to receive chemotherapy for triple negative metastatic breast cancer. 6. Measurable disease (at least one unidimensionally measurable lesion) 7. Normal coagulation profile; including INR/ PTT ≤ 1.5 x ULN. 8. ECOG 0,1 or 2 9. Life expectancy of 12 or more weeks. 10. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained. 11. Able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Neoadjuvant setting 1. Positive for ER, PR or Her2 as defined by local standards 2. Clinical or radiological evidence of metastatic disease 3. Inadequate or unusable tissue as the only tissue available for biopsy 4. Other non-malignant systemic disease to preclude treatment with chemotherapy regimen or prevent follow-up 5. Diagnosis of inflammatory breast cancer 6. Known infection with HIV or hepatitis Metastatic setting 1. Patients with ER+, PR+ or HER2+ tumors demonstrated by local standards 2. Inadequate or unusable tissue as the only tissue available for biopsy 3. Other non-malignant systemic disease to preclude treatment with standard chemotherapy regimen or prevent follow-up 4. Abnormal coagulation profile 5. The planned concurrent administration of therapies (e.g. palliative radiotherapy) that target metastatic sites accessible for biopsy 6. Known infection with HIV or hepatitis
References
Publications (0)
Data not yet available