Clinical trial · Interventional
Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.
- 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)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.
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 (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral letrozole once daily for 16 weeks.
- interventionNames
- Drug: letrozole
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral tamoxifen citrate once daily for 16 weeks.
- interventionNames
- Drug: tamoxifen citrate
Primary outcomes (1)
- measure
- Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
- timeFrame
- up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast adenocarcinoma
* Clinically T2 tumor and/or \> 1 cm by echography
* Estrogen receptor (ER)-positive and \> 10% of the tumor cells positive
* No ER-negative disease
* No prior breast cancer
* No metastatic or inflammatory breast adenocarcinoma
PATIENT CHARACTERISTICS:
* Postmenopausal
* No cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
* No prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
* No mental incapacitation that would preclude consent
* No contraindication to tamoxifen citrate or letrozole
PRIOR CONCURRENT THERAPY:
* More than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
* No concurrent therapy that would modify the expression of the genes regulated by estrogen
* No concurrent participation in another clinical studyReferences
Publications (0)
Data not yet available