Clinical trial · Interventional
Neoadjuvant Endocrine Therapy in Breast Cancer
Letrozole as Neoadjuvant Treatment in Postmenopausal and Premenopausal Patients With Highly Endocrine Responsive Operable Breast Cancer
NCT03397537CI-TRIAL-00031208completedPhase 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)
The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma.
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 |
|---|---|---|---|
| Highly Endocrine Responsive Operable Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH analogue | Drug | — | UNRESOLVED |
| Letrozole 2.5Mg Tablet | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- the postmenopausal
- description
- 2.5 mg letrozole every day for six months
- interventionNames
- Drug: Letrozole 2.5Mg Tablet
- type
- EXPERIMENTAL
- label
- the premenopausal
- description
- 2.5 mg letrozole daily along with a GnRH analogue for ovarian suppression, which was administered as an intramuscular injection of 3.75 mg triptorelin every 28 days for 6 months.
- interventionNames
- Drug: Letrozole 2.5Mg Tablet
- Drug: GnRH analogue
Primary outcomes (1)
- measure
- ORR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females ≥18 years 2. ER-positive (≥50%), PgR-positive (≥50% ), HER2-negative, and previously untreated, non-metastatic primary invasive BC. 3. The tumour size had to be \>1 cm. Exclusion Criteria: 1. male patients; 2. patients with inflammatory breast cancer or distant metastasis; 3. patients who were previously treatment treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; 4. patients with a second concomitant neoplasm; 5. patients who could not meet the eligibility criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.