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Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

Primary Purpose

HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anastrozole
Exemestane
Laboratory Biomarker Analysis
Letrozole
Quality-of-Life Assessment
Questionnaire Administration
Tamoxifen Citrate
Toremifene Citrate
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2/Neu Negative

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to provide written informed consent

  • A diagnosis of invasive breast cancer, with or without an in situ component, that is:

    • Originally identified by screening mammography
    • Characterized by standard diagnostic mammography +/- breast ultrasound
    • Clinically node negative
    • Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=< 2 cm, node negative, unifocal invasive)
    • Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each > 5/8
    • Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
    • ki-67 proliferation scored, < 20%
    • Clinical Nottingham grade 1 or 2
    • Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk
  • Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range
  • Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM)
  • Willing to undergo routine surveillance with breast ultrasound and/or mammography

Exclusion Criteria:

  • Known contraindication to aromatase inhibitor or SERM therapy
  • Pregnant at time of or within prior year of diagnosis
  • Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla
  • Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
  • Prior use of aromatase inhibitor therapy apart from assisted reproduction
  • Prior use of SERM
  • Unmanaged/uncontrolled mental health disorder
  • Life expectancy < 6 months (m) for any cause
  • Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive
  • DCIS with focal invasion

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (AI, SERM)

Arm Description

Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Conversion from oral endocrine therapy for any reason to guideline-directed therapy
Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).

Secondary Outcome Measures

Advanced imaging (if performed on any subset of patients)
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services
Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early-stage breast cancer. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Effect of age
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Effect of comorbidity severity interaction
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Effects emanating from tertiary care
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)
Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).

Full Information

First Posted
July 31, 2017
Last Updated
December 26, 2018
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03238703
Brief Title
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
Official Title
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative closure based on sponsor recommendation, prior to subject enrollment
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
March 14, 2023 (Anticipated)
Study Completion Date
March 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the conversion rate from a standard low-toxicity approach to guideline-directed therapy which includes surgery +/- radiation therapy as a result of progression of disease or patient/provider choice. II. To examine factors that might differ between those who convert from the low-toxicity approach to the guideline-directed therapy and those do not convert. SECONDARY OBJECTIVES: I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a prolonged neoadjuvant fashion. II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and QALY gains. III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of systemic endocrine therapy alone. OUTLINE: Patients receive exemestane orally (PO) once daily (QD), anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage 0 Breast Cancer, Stage IA Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (AI, SERM)
Arm Type
Experimental
Arm Description
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Anastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
Aromasin, FCE-24304
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
CGS 20267, Femara
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Tamoxifen Citrate
Other Intervention Name(s)
Apo-Tamox, Clonoxifen, Dignotamoxi, Ebefen, Emblon, Estroxyn, Fentamox, Gen-Tamoxifen, Genox, ICI 46,474, ICI-46474, Jenoxifen, Kessar, Ledertam, Lesporene, Nolgen, Noltam, Nolvadex, Nolvadex-D, Nourytam, Novo-Tamoxifen, Novofen, Noxitem, Oestrifen, Oncotam, PMS-Tamoxifen, Soltamox, TAM, Tamax, Tamaxin, Tamifen, Tamizam, Tamofen, Tamoxasta, Tamoxifeni Citras, Zemide
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Toremifene Citrate
Other Intervention Name(s)
Acapodene, Fareston, FC-1157a, GTx-006
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Conversion from oral endocrine therapy for any reason to guideline-directed therapy
Description
Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Advanced imaging (if performed on any subset of patients)
Description
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services
Description
Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early-stage breast cancer. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Effect of age
Description
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Effect of comorbidity severity interaction
Description
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
Description
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Effects emanating from tertiary care
Description
Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years
Title
Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)
Description
Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent A diagnosis of invasive breast cancer, with or without an in situ component, that is: Originally identified by screening mammography Characterized by standard diagnostic mammography +/- breast ultrasound Clinically node negative Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=< 2 cm, node negative, unifocal invasive) Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each > 5/8 Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines ki-67 proliferation scored, < 20% Clinical Nottingham grade 1 or 2 Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM) Willing to undergo routine surveillance with breast ultrasound and/or mammography Exclusion Criteria: Known contraindication to aromatase inhibitor or SERM therapy Pregnant at time of or within prior year of diagnosis Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS) Prior use of aromatase inhibitor therapy apart from assisted reproduction Prior use of SERM Unmanaged/uncontrolled mental health disorder Life expectancy < 6 months (m) for any cause Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive DCIS with focal invasion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijayakrishna Gadi
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

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