Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
- Conditions
- Node-negative Breast CancerBreast CarcinomaBreast CancerHER2-negative Breast Cancer
- Interventions
- Registration Number
- NCT05150652
- Lead Sponsor
- Irada Ibrahim-zada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Neoadjuvant Endocrine Therapy Letrozole 2.5mg 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. Neoadjuvant Endocrine Therapy Anastrozole 1mg 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. Neoadjuvant Endocrine Therapy Exemestane 25 mg 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. Neoadjuvant Endocrine Therapy Tamoxifen 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.
- Primary Outcome Measures
Name Time Method Change in margin status 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 Outcome Measures
Name Time Method Residual cancer burden After neoadjuvant treatment and surgery (approximately 6 months from diagnosis) The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Pattern of response After neoadjuvant treatment and surgery (approximately 6 months from diagnosis) Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)
Change in satisfaction with cosmetic outcome After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery) The Breast-Q© is a patient reported outcome measure for breast surgery that measures patient reported satisfaction and quality of life (QOL) developed by Memorial Sloan Kettering Cancer Center. It is comprised of 10 scales that address: 1) psychosocial well-being, 2) sexual well-being, 3) satisfaction with breasts, 4) physical well-being, 5) adverse effects of radiation, 6) satisfaction with information - breast surgeon, 7) satisfaction with information - radiation oncologist, 8) satisfaction with surgeon, 9) satisfaction with medical team, 10) satisfaction with office staff. Each module is scored from 0-100 where higher scores reflect a better outcome.
Trial Locations
- Locations (1)
University of Kentucky Markey Cancer Center
🇺🇸Lexington, Kentucky, United States