Clinical trial · Interventional
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer
Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy Decisions In Older Women With Early-Stage Breast Cancer
NCT04272801CI-TRIAL-00096741POWERactive not recruitingPhase 2Results postedClinicalTrials.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)
This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-operative endocrine therapy (pre-ET) with assessment of tolerance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).
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 Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient reported outcomes | Behavioral | — | UNRESOLVED |
| tamoxifen, letrozole, anastrozole, or exemestane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-operative endocrine therapy
- description
- All participants enrolled to the study will receive 3 months of pre-operative endocrine therapy (e.g. tamoxifen or aromatase inhibitors (AIs) such as letrozole, anastrozole, or exemestane). The choice and dose of endocrine therapy will be at the discretion of the treating medical oncologist.
- interventionNames
- Drug: tamoxifen, letrozole, anastrozole, or exemestane
- Behavioral: Patient reported outcomes
Primary outcomes (2)
- measure
- Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
- timeFrame
- up to 6 months
- description
- Change in participant response to question regarding preference for adjuvant radiation treatment
- measure
- Change in Surgeon Preference for Adjuvant Radiation Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria (Summary): * ECOG performance status 0-2 * Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled * Tumor size ≤ 2 cm * Patient has elected BCS as surgical choice * Eligible to receive tamoxifen or an aromatase inhibitor * Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS Exclusion Criteria (Summary): * Prior or current use of endocrine therapy for breast cancer * History of ipsilateral breast radiation * Pregnancy or lactation * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway
References
Publications (0)
Data not yet available
No reference posted for this study.