Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in margin status
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Neoadjuvant Endocrine Therapy
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.
Intervention: Tamoxifen (Drug)
Neoadjuvant Endocrine Therapy
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.
Intervention: Anastrozole 1mg (Drug)
Neoadjuvant Endocrine Therapy
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.
Intervention: Letrozole 2.5mg (Drug)
Neoadjuvant Endocrine Therapy
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.
Intervention: Exemestane 25 mg (Drug)
Outcomes
Primary Outcomes
Change in margin status
Time Frame: Baseline, 6-months after neoadjuvant treatment and surgery
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
- Residual cancer burden(After neoadjuvant treatment and surgery (approximately 6 months from diagnosis))
- Pattern of response(After neoadjuvant treatment and surgery (approximately 6 months from diagnosis))
- Change in satisfaction with cosmetic outcome(After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery))
Investigators
Irada Ibrahim-zada
Assistant Professor
University of Kentucky