Neoadjuvant endocrine therapy for early stage breast cancer
Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
This study is testing if taking hormone therapy before surgery can help postmenopausal women with early-stage breast cancer have better surgery results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05150652 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neoadjuvant endocrine therapy in treating early-stage estrogen receptor-positive, HER2-negative breast cancer. The goal is to determine if this treatment approach can lead to higher rates of margin negativity in lumpectomy specimens. Participants will receive medications such as Anastrozole, Letrozole, Exemestane, or Tamoxifen prior to surgery. The study focuses on postmenopausal women with clinically node-negative invasive breast cancer.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with pathologically confirmed invasive breast cancer that is clinically stage I-II and lymph node negative.
Not a fit: Patients with progesterone receptor negativity or high-grade tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce the likelihood of cancer recurrence in patients with early-stage breast cancer.
How similar studies have performed: Other studies have shown promise with neoadjuvant endocrine therapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Irada Ibrahim-zada, MD — University of Kentucky
- Study coordinator: Yvonne E Taul, RN
- Email: yvonne.taul@uky.edu
- Phone: 859-323-2354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.