Breast CancerPhase 2NCT02476786
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
A Phase 2 study testing FACT-B, Goserelin and Anastrozole in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer of Breast, Breast Neoplasms
- What is being tested?
- FACT-B, Goserelin and Anastrozole
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 31 Jul 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.
- Disease must be ER+ and HER2-.
- Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
- 70 years of age or older.
- ECOG performance status ≤ 3
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Prior surgery for this cancer
- A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
- Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
- Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Rebecca L Aft, M.D., Ph.D., 314-747-0063, aftr@wustl.edu
Tracey Guthrie, 314-747-4404, guthriet@wustl.edu
About this study
Official title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.
- Being tested
- FACT-B, Goserelin, Anastrozole, Exemestane, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACT-BBehavioural
The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).
GoserelinDrug
Also called Goserelin acetate, Zoladex
AnastrozoleDrug
Also called Arimidex®
ExemestaneDrug
Also called Aromasin®
FulvestrantDrug
Also called Faslodex®
TamoxifenDrug
Also called Nolvadex®
Archived tissue collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Endocrine therapy alone | Experimental | * Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen
* Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment
* After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy
* Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire
* Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment) Receives: Behavioral: FACT-B; Drug: Goserelin; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Tamoxifen; Other: Archived tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
- Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
- In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores <18 indicating low risk.
Measured: 6 months
Secondary outcomes (4)
Breast cancer-specific survival
Measured: 6 months
Breast cancer-specific survival
Measured: 1 year
Breast cancer-specific survival
Measured: 2 years
Rate of overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start17 Jan 2017
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Responsible party
- Sponsor
- Investigators
- Rebecca L Aft, M.D, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476786
- Sponsor's protocol ID
- 201611010
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2015
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
- ClinicalTrials.gov ID
- NCT02476786
- Acronym / sponsor ID
- 201611010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- 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.
Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocrine therapy alone | Experimental | Behavioral: FACT-B, Drug: Goserelin, Drug: Anastrozole, Drug: Exemestane, Drug: Fulvestrant, Drug: Tamoxifen, Other: Archived tissue collection* Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen * Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment * After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy * Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire * Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment) |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.
- Disease must be ER+ and HER2-.
- Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
- 70 years of age or older.
Key exclusion criteria (6 listed)
- Prior surgery for this cancer
- A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
- Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
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 |
|---|---|---|
| FACT-BThe FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness). | Behavioural | Endocrine therapy alone |
| GoserelinAlso: Goserelin acetate, Zoladex | Drug | Endocrine therapy alone |
| AnastrozoleAlso: Arimidex® | Drug | Endocrine therapy alone |
| ExemestaneAlso: Aromasin® | Drug | Endocrine therapy alone |
| FulvestrantAlso: Faslodex® | Drug | Endocrine therapy alone |
| TamoxifenAlso: Nolvadex® | Drug | Endocrine therapy alone |
| Archived tissue collection | Other | Endocrine therapy alone |
Primary outcome
Response rate
Time frame: 6 months
* Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. * In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores <18 indicating low risk.
4 secondary outcomes
Breast cancer-specific survival
Time frame: 6 months
Breast cancer-specific survival
Time frame: 1 year
Breast cancer-specific survival
Time frame: 2 years
Rate of overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Rebecca L Aft, M.D, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FACT-B, Goserelin and Anastrozole in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca L Aft, M.D., Ph.D. (314-747-0063, aftr@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 6 months). 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 Jul 2026.