HER2/Neu NegativePhase 4NCT03238703
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
A Phase 4 study testing Anastrozole, Exemestane and Laboratory Biomarker Analysis in people with HER2/Neu Negative and Invasive Breast Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal
- What is being tested?
- Anastrozole, Exemestane and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 14 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage 0 Breast Cancer, Stage IA Breast Cancer
- Being tested
- Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Anastrazole, Arimidex, ICI D1033, ICI-D1033
Given PO
ExemestaneDrug
Also called Aromasin, FCE-24304
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
LetrozoleDrug
Also called CGS 20267, Femara
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Tamoxifen CitrateDrug
Also called Apo-Tamox, Clonoxifen, Dignotamoxi, Ebefen
Given PO
Toremifene CitrateDrug
Also called Acapodene, Fareston, FC-1157a, GTx-006
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (AI, SERM) | Experimental | 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. Receives: Drug: Anastrozole; Drug: Exemestane; Other: Laboratory Biomarker Analysis; Drug: Letrozole; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Tamoxifen Citrate; Drug: Toremifene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 5 years
Secondary outcomes (7)
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Sep 2018 (estimated)
- Primary completion14 Mar 2023 (estimated)
- Study completion14 Mar 2025 (estimated)
Why it stopped: Administrative closure based on sponsor recommendation, prior to subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2/Neu NegativeStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vijayakrishna Gadi, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238703
- Sponsor's protocol ID
- 9764
- Other IDs
- NCI-2017-00724, 9764, P30CA015704
- Status last verified
- Dec 2018
- First submitted
- 31 Jul 2017
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
- ClinicalTrials.gov ID
- NCT03238703
- Acronym / sponsor ID
- 9764
- Conditions
- HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage 0 Breast Cancer, Stage IA Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative closure based on sponsor recommendation, prior to subject enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 14 Mar 2023 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (AI, SERM) | Experimental | Drug: Anastrozole, Drug: Exemestane, Other: Laboratory Biomarker Analysis, Drug: Letrozole, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Tamoxifen Citrate, Drug: Toremifene CitratePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Able to provide written informed consent
- A diagnosis of invasive breast cancer, with or without an in situ component, that is:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAlso: Anastrazole, Arimidex, ICI D1033, ICI-D1033Given PO | Drug | Treatment (AI, SERM) |
| ExemestaneAlso: Aromasin, FCE-24304Given PO | Drug | Treatment (AI, SERM) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (AI, SERM) |
| LetrozoleAlso: CGS 20267, FemaraGiven PO | Drug | Treatment (AI, SERM) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (AI, SERM) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (AI, SERM) |
| Tamoxifen CitrateAlso: Apo-Tamox, Clonoxifen, Dignotamoxi, EbefenGiven PO | Drug | Treatment (AI, SERM) |
| Toremifene CitrateAlso: Acapodene, Fareston, FC-1157a, GTx-006Given PO | Drug | Treatment (AI, SERM) |
Primary outcome
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).
7 secondary outcomes
Advanced imaging (if performed on any subset of patients)
Time frame: Up to 5 years
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
Effect of age
Time frame: Up to 5 years
Effect of comorbidity severity interaction
Time frame: Up to 5 years
Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
Time frame: Up to 5 years
Effects emanating from tertiary care
Time frame: Up to 5 years
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijayakrishna Gadi principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anastrozole, Exemestane and Laboratory Biomarker Analysis in people with HER2/Neu Negative and Invasive Breast Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion from oral endocrine therapy for any reason to guideline-directed therapy (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.