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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Endocrine Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole 1mg | Drug | Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in margin status | 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. | Baseline, 6-months after neoadjuvant treatment and surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Residual cancer burden | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in largest caliper measurement | Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor | Baseline, 6-months after neoadjuvant treatment and surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irada Ibrahim-zada, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36410913 | Derived | McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3. |
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| Letrozole 2.5mg | Drug | Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days. |
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| Exemestane 25 mg | Drug | Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days. |
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| Tamoxifen | Drug | Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days. |
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| After neoadjuvant treatment and surgery (approximately 6 months from diagnosis) |
| Pattern of response | Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response) | After neoadjuvant treatment and surgery (approximately 6 months from diagnosis) |
| Change in satisfaction with cosmetic outcome | 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. | After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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