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

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ClinicalTrials.gov Identifier: NCT03238703
Recruitment Status : Withdrawn (Administrative closure based on sponsor recommendation, prior to subject enrollment)
First Posted : August 3, 2017
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
HER2/Neu Negative Invasive Breast Carcinoma Postmenopausal Stage 0 Breast Cancer Stage IA Breast Cancer Drug: Anastrozole Drug: Exemestane Other: Laboratory Biomarker Analysis Drug: Letrozole Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Tamoxifen Citrate Drug: Toremifene Citrate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 14, 2023
Estimated Study Completion Date : March 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Treatment (AI, SERM)
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.
Drug: Anastrozole
Given PO
Other Names:
  • Anastrazole
  • Arimidex
  • ICI D1033
  • ICI-D1033
  • ZD-1033

Drug: Exemestane
Given PO
Other Names:
  • Aromasin
  • FCE-24304

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Tamoxifen Citrate
Given PO
Other Names:
  • 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

Drug: Toremifene Citrate
Given PO
Other Names:
  • Acapodene
  • Fareston
  • FC-1157a
  • GTx-006




Primary Outcome Measures :
  1. Conversion from oral endocrine therapy for any reason to guideline-directed therapy [ Time Frame: Up to 5 years ]
    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 :
  1. Advanced imaging (if performed on any subset of patients) [ Time Frame: Up to 5 years ]
    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).

  2. 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 [ Time Frame: Up to 5 years ]
    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).

  3. Effect of age [ Time Frame: Up to 5 years ]
    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).

  4. Effect of comorbidity severity interaction [ Time Frame: Up to 5 years ]
    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).

  5. Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor) [ Time Frame: Up to 5 years ]
    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).

  6. Effects emanating from tertiary care [ Time Frame: Up to 5 years ]
    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).

  7. Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound) [ Time Frame: Up to 5 years ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238703


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Vijayakrishna Gadi Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03238703     History of Changes
Other Study ID Numbers: 9764
NCI-2017-00724 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9764 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Tamoxifen
Toremifene
Letrozole
Anastrozole
Exemestane
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs