Clinical trial · Observational
CPR Prediction After Neoadjuvant Using Excisional Biopsy By Radiofrequency In Breast Cancer From II-III UICC Stages.
Complete Pathological Response Prediction After Neoadjuvant Treatment Using Excisional Biopsy By Radiofrequency In Breast Cancer From II-III UICC Stages.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment was very low.
Summary
Brief summary (as posted)
This project aims to determine whether biopsy using radiofrequency is a procedure suitable for this patient selection. Findings from biopsy will be correlated with the conventional surgery ones. If the technique is validated to predict the presence or absence of residual tumor, breast surgery could be avoided in cases of absence of tumor.
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, HER2+, Luminal B Breast Tumors (Stages II-III)in Female Patients | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast tumors sensitive to neoadjuvant
- description
- Treated patients as usual clinical practice with unicentered tumors in stages II or III and good response determined by MR after 6 cycles of treatment (less than 2 cm apparent residual injury) will be consecutively subjected to radiofrequency biopsy and the surgery previously established for each case (Tumorectomy or mastectomy). Before surgery, the sentinel node will be biopsied in order to define the surgical treatment on the axilla (none in case of negative sentinel node, axillary lymphadenectomy if positive). The tumor samples obtained by percutaneous radiofrequency and mastectomy-Tumorectomy biopsy will be studied thoroughly to define the correlation between the two.
Primary outcomes (1)
- measure
- determination of the negative predictive value (NPV) of the excisional biopsy technique
- timeFrame
- up to 15 months
- description
- Proportion of biopsies which PCR, are really PCR in the surgical specimen.
Secondary outcomes (1)
- measure
- Evaluation of sensitivity and specificity of the excisional biopsy by radiofrequency technique
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent Form signed * Adequate Performance status (ECOG 0-1) * Female patients with unifocal breast tumors (stages II-III, TN, HER2+ or Luminal B) very sensitive to neoadjuvant medical treatment (5 to 6 months in accordance with the current standard) * Patients who submit clinical-radiologic greater response to the treatment administered (equal to or less than 1.5 cm in NMR residual tumor) Exclusion Criteria: * Ki67\<14% * Excisional biopsy Contraindications
References
Publications (0)
Data not yet available