Breast Cancer, HER2-negative Breast Cancer, Node-negative Breast Cancer, Breast Carcinoma
Conditions
Keywords
Neoadjuvant endocrine therapy, Early stage
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.
Interventions
DRUGAnastrozole 1mg
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
DRUGLetrozole 2.5mg
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
DRUGExemestane 25 mg
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
DRUGTamoxifen
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
Sponsors
Irada Ibrahim-zada
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in largest caliper measurement | Baseline, 6-months after neoadjuvant treatment and surgery | Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor |
Countries
United States
Outcome results
None listed