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

Primary Purpose

Breast Cancer, HER2-negative Breast Cancer, Node-negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anastrozole 1mg
Letrozole 2.5mg
Exemestane 25 mg
Tamoxifen
Sponsored by
Erin Burke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Neoadjuvant endocrine therapy, Early stage

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky Markey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant Endocrine Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Pattern of response
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
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.

Full Information

First Posted
November 24, 2021
Last Updated
July 25, 2023
Sponsor
Erin Burke
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1. Study Identification

Unique Protocol Identification Number
NCT05150652
Brief Title
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Official Title
Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erin Burke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2-negative Breast Cancer, Node-negative Breast Cancer, Breast Carcinoma
Keywords
Neoadjuvant endocrine therapy, Early stage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Endocrine Therapy
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Anastrozole 1mg
Other Intervention Name(s)
Arimidex
Intervention Description
Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
Intervention Type
Drug
Intervention Name(s)
Letrozole 2.5mg
Other Intervention Name(s)
Femara
Intervention Description
Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
Intervention Type
Drug
Intervention Name(s)
Exemestane 25 mg
Other Intervention Name(s)
Aromasin
Intervention Description
Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Soltamox
Intervention Description
Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.
Primary Outcome Measure Information:
Title
Change in margin status
Description
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.
Time Frame
Baseline, 6-months after neoadjuvant treatment and surgery
Secondary Outcome Measure Information:
Title
Residual cancer burden
Description
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
Time Frame
After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Title
Pattern of response
Description
Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)
Time Frame
After neoadjuvant treatment and surgery (approximately 6 months from diagnosis)
Title
Change in satisfaction with cosmetic outcome
Description
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.
Time Frame
After neoadjuvant treatment and surgery (approximately 6 months and 12 months post-surgery)
Other Pre-specified Outcome Measures:
Title
Change in largest caliper measurement
Description
Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor
Time Frame
Baseline, 6-months after neoadjuvant treatment and surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin E Burke, MD
Phone
859-257-4490
Email
erin.burke@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin E Burke, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin E Burke, MD
Phone
859-323-2222
Email
erin.burke@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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