Clinical trial · Interventional
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
NCT05150652CI-TRIAL-00124676completedPhase 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 goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.
Conditions
Conditions (4)
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 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Node-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole 1mg | Drug | Anastrozole | ALIAS |
| Exemestane 25 mg | Drug | Exemestane | ALIAS |
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Endocrine Therapy
- description
- Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.
- interventionNames
- Drug: Anastrozole 1mg
- Drug: Letrozole 2.5mg
- Drug: Exemestane 25 mg
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Change in margin status
- timeFrame
- Baseline, 6-months after neoadjuvant treatment and surgery
- description
- Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed invasive breast cancer, clinically stage I-II. * Clinically lymph node negative * Eligible for anti-endocrine treatment (per medical oncologist) * Postmenopausal women * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Progesterone receptor negativity * High grade tumor * Synchronous non-breast malignancy * Receiving any other investigational agents that could impact the efficacy of this trial regimen * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study * Uncontrolled intercurrent illness * Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements
References
Publications (1)
- DERIVEDMcDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3. PMID 36410913