Clinical trial · Interventional
A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy
- 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 researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.
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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood draw | Other | — | UNRESOLVED |
| core needle biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer
- description
- All study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI (anastrazole 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet Which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure.
- interventionNames
- Procedure: core needle biopsy
- Other: blood draw
Primary outcomes (1)
- measure
- assess the change in Ki67
- timeFrame
- baseline to at least 2 weeks of endocrine therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2- * Scheduled to undergo upfront surgery * Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only) Exclusion Criteria: * History of breast cancer * Receipt of ET for risk reduction in the previous 3 months * Stage IV disease at presentation * Scheduled to undergo neoadjuvant systemic chemotherapy * Pregnant
References
Publications (0)
Data not yet available