Clinical trial · Interventional
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.
NCT00617968CI-TRIAL-00002596completedPhase 2ClinicalTrials.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)
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological 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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DOCETAXEL | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of clinical and radiological response evaluated according to RECIST criteria
- timeFrame
- During the study conduct
Secondary outcomes (1)
- measure
- Rate of histological response
- timeFrame
- During the study conduct
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status. * Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral * Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram) * Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers) * HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry * Histological grade I or II * Menopausal patients aged greater than or equal to 60 years * Patients with ECOG PS greater than or equal to 2 * Satisfactory hematological, hepatic and renal functions: * Hemoglobin greater than or equal to 10 g/dL * Platelet count greater than or equal to 100x109/L * Polynuclear neutrophil count greater than 1.5x109/L * Creatinine less than or equal to ≤ 1.5 ULN * AST/ALT less than or equal to 1.5 ULN * Alkaline phosphatases less than or equal to 2.5 ULN * Patients able to be followed throughout the study * Patient's consent obtained. Exclusion Criteria: * Inflammatory or T4 breast cancer * T1 tumor * Patients whose tumor is deemed by the doctor to be difficult to evaluate * Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset * RE and RP receptors negative or unknown * HER 2/neu positive at 3 + * Non-menopausal patients * Surgical biopsy and/or ganglion dissection before neoadjuvant treatment * Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months * Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results * Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated * Allergy to polysorbate 80 * Hypersensitivity to docetaxel * Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study * Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons
References
Publications (0)
Data not yet available
No reference posted for this study.