Clinical trial · Observational
Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
NCT01514565CI-TRIAL-00017159unknownClinicalTrials.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)
This is a prospective observational study aimed to validate biomarkers that predict response.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Histological status of retinoblastoma tumour suppressor (RB)
- timeFrame
- Nine weeks
- description
- The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.
Secondary outcomes (2)
- measure
- Correlation of RB and other biomarkers
- timeFrame
- Nine weeks
- description
- 1. Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR 2. Correlation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)
- measure
- Determine the utility of an RB molecular test
- timeFrame
- Assessed within 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * Histologically-confirmed triple negative invasive breast carcinoma * Any type of ductal or lobular invasive carcinoma * Patients with or without BRCA-1 and BRCA-2 mutations are eligible to participate * Life expectancy \> 6 months * Pre-, Peri- or Postmenopausal * Clinical Stage T2-4, N0-3, M0 (Stage II-III) * Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial * Adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. However, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario. Exclusion Criteria: * Prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM) * Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician). * Only ductal/lobular carcinoma in situ but not invasive component * Any sort of confirmed metastatic disease (AJCC Stage IV at diagnosis) * Any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy * Pregnant or lactating, in case this precludes the subject to receive chemotherapy. * Impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. This will be exclusively decided by the treating oncologists.
References
Publications (0)
Data not yet available
No reference posted for this study.