Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150652
• Other study ID #: MCC-21-BRE-54
• Status: Recruiting
• Phase: Phase 2
• Start date: February 18, 2022
• Est. completion date: October 2036

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: Yvonne E Taul, RN
• Phone: 859-323-2354
• Email: yvonne.taul[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2036
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• HER2-negative Breast Cancer
• Node-negative Breast Cancer

Intervention

Drug:
• Anastrozole 1mg
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
• Letrozole 2.5mg
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
• Exemestane 25 mg
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
• Tamoxifen
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.

Locations

Country	Name	City	State
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Veronica Morgan Jones

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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	After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Secondary	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)
Secondary	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)