Breast CancerPhase 2NCT05837455
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
A Phase 2 study testing VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score and PAM50-based Prosigna breast cancer gene signature assay in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score and PAM50-based Prosigna breast cancer gene signature assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 30 Nov 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed newly diagnosed clinical stage II or III (by AJCC 8th edition - at least T2, any N, M0 or if N1+ then any T) ER-positive (ER > 10%), any PR, and HER2-negative breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal.
- HER2 negative must be assessed by FISH or IHC staining 0 or 1+ according to ASCO/CAP guidelines.
- A palpable mass is not required; however, tumor size must be either:
- ≥2 cm in one dimension by clinical or radiographic examination (WHO criteria), if clinically axillary lymph node negative OR
- Measureable (≥10 mm) by modified RECIST v1.1 for breast MRI (see Section 9.0), if histologically confirmed resectable locoregional nodal involvement.
- ECOG performance status 0 or 1.
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- Eligible to receive neoadjuvant aromatase inhibitor, as per treating physician.
- Eligible to receive neoadjuvant standard of care anthracycline- and/or taxane-based chemotherapy regimen, as per treating physician.
- Able to tolerate breast MRI with intravenous contrast administration. Must be able to complete the applicable MRI screening evaluation form.
- Adequate bone marrow and organ function, as determined by the treating physician.
- Known history of hepatitis C virus (HCV) infection is permissible provided the patient has been treated and cured.
- At least 18 years of age.
- Postmenopausal status, defined as one of the following:
- Age ≥ 60 years
- Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more
- Status post bilateral oophorectomy, total hysterectomy
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable), and willing and able to comply with scheduled visits and treatment schedule.
Who cannot join
- Inflammatory breast cancer (cT4d disease as per AJCC 8th edition).
- Locally recurrent or metastatic disease (cM1 disease as per AJCC 8th edition).
- Bilateral breast cancer.
- Prior systemic therapy for the indexed breast cancer.
- Pre-existing Grade ≥2 neuropathy.
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
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- A history of other malignancy ≤5 years prior to the indexed breast cancer diagnosis with the following exceptions:
- Basal cell or squamous cell carcinoma of the skin which were treated with local resection only
- Adequately treated carcinoma in situ of the cervix.
- Prior or concurrent malignancy whose natural history or treatment will not interfere with the safety or efficacy assessments of the indexed breast cancer. In this event, review and approval by the study PI is required.
- Concurrent participation in any investigational therapeutic trial for treatment of breast cancer.
- Known HIV positivity that in the judgement of the treating physician would impact safety of chemotherapy receipt.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to anastrozole, taxanes (paclitaxel or nab-paclitaxel), anthracyclines (doxorubicin or epirubicin) or cyclophosphamide.
- Evidence of uncontrolled ongoing or active infection, requiring parenteral anti-bacterial, anti-viral, or anti-fungal therapy ≤ 7 days prior to administration of study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- Any uncontrolled medical condition that in the opinion of the Investigator would pose a risk to participant safety or interfere with study participation or interpretation of individual participant results.
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
Nusayba A Bagegni, M.D., 314-273-3022, nbagegni@wustl.edu
Nusayba A Bagegni, M.D.
About this study
Official title: NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy, with a primary focus on outcomes in Black patients.
Read the detailed description
Risk category is defined as follows:
- Low risk:
- Baseline Ki67 ≤ 10% (OR)
- Luminal A molecular intrinsic subtype by PAM50
- High risk:
- Non-Luminal A molecular intrinsic subtype by PAM50 (OR)
- In cases of non-diagnostic PAM50 molecular intrinsic subtype, patients will enroll in the high-risk group and undergo Week 4 tumor biopsy.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score, PAM50-based Prosigna breast cancer gene signature assay, Anastrozole, Combination anthracycline and/or taxane based treatment
- Keywords
- breast cancer, postmenopausal women, Ki67, PAM50 subtype, breast cancer disparities
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENTANA MIB-1 Ki67 assayDevice
Ki67 scoring determination (standard of care) utilizing the Ki67 MIB-1 assay (clone 30-9) (VENTANA) will be performed at baseline, Week 4 (+/- 14 days - high-risk group only), and at time of surgery in accordance with the International Ki67 in Breast Cancer Working Group guidelines.
Oncotype DX® Recurrence ScoreDevice
Oncotype DX® Recurrence Score (RS) testing - assessing expression of 21 genes including 16 cancer-related genes and 5 reference genes - will be performed as standard of care in a central laboratory (Exact Sciences) on RNA extracted from formalin-fixed paraffin-embedded core-biopsy samples.
PAM50-based Prosigna breast cancer gene signature assayDevice
This PAM50-based Prosigna breast cancer gene signature assay for intrinsic molecular subtype determination will be performed on formalin-fixed, paraffin-embedded (FFPE) core-biopsy samples.
AnastrozoleDrug
Standard of care. All patients must start on anastrozole at time of enrollment but may switch to another aromatase inhibitor (letrozole or exemestane) due to toxicity or financial/other concerns at discretion of investigator after a discussion with the PI. Every effort to minimize interruption of aromatase inhibitor (AI) therapy is recommended.
Combination anthracycline and/or taxane based treatmentDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Low-risk group | Experimental | * Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50.
* An additional blood draw for research purposes at Week 4 (no breast tumor biopsy at this time point) and continue to receive 5 additional 28-day cycles of anastrozole.
* After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. Receives: Device: VENTANA MIB-1 Ki67 assay; Device: Oncotype DX® Recurrence Score; Device: PAM50-based Prosigna breast cancer gene signature assay; Drug: Anastrozole |
| High-risk endocrine-sensitive group | Experimental | * Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50.
* An additional blood draw and breast tumor tissue collection at Week 4 to assess Ki67. Patients with Week 4 Ki67 ≤10% (the high-risk endocrine-sensitive group) will continue to receive 5 additional 28-day cycles of anastrozole.
* After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. Receives: Device: VENTANA MIB-1 Ki67 assay; Device: Oncotype DX® Recurrence Score; Device: PAM50-based Prosigna breast cancer gene signature assay; Drug: Anastrozole |
| High-risk endocrine-resistant group | Experimental | * Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50.
* An additional blood draw and breast tumor tissue collection at Week 4 to assess Ki67. Patients with Week 4 Ki67 >10% (the high-risk endocrine-resistant group) will receive escalated therapy with ~5-6 additional months of standard of care chemotherapy (combination anthracycline- and/or taxane-based at the discretion of their physician).
* After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. Receives: Device: VENTANA MIB-1 Ki67 assay; Device: Oncotype DX® Recurrence Score; Device: PAM50-based Prosigna breast cancer gene signature assay; Drug: Combination anthracycline and/or taxane based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)
- ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1.
- Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions thought to be non-malignant should be further investigated before CR can be accepted.
- Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of treatment (estimated to be 6 months)
Secondary outcomes (4)
Breast conservation surgery (BCS) conversion rate by cohort and treatment assignment
Measured: Through completion of surgery (estimated to be 6 months)
Proportion of patients who will require oncoplastic breast reduction surgery before and after neoadjuvant treatment
Measured: Through completion of surgery (estimated to be 6 months)
Objective response rate (ORR) by breast MRI in the high-risk endocrine-sensitive group
- ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to modified RECIST v1.1.
- Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions thought to be non-malignant should be further investigated before CR can be accepted.
- Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of treatment (estimated to be 6 months)
Objective response rate (ORR) by breast MRI in the high-risk endocrine-resistant group (high risk patients with week 4 Ki67 > 10% post anastrozole)
- ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to modified RECIST v1.1.
- Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions thought to be non-malignant should be further investigated before CR can be accepted.
- Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
Measured: Through completion of treatment (estimated to be 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start30 May 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Swim Across America, The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Nusayba Bagegni, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837455
- Sponsor's protocol ID
- 202305007
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05837455
- Acronym / sponsor ID
- 202305007
- Conditions
- Breast Cancer, Cancer of the Breast
- Keywords
- breast cancer, postmenopausal women, Ki67, PAM50 subtype, breast cancer disparities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Swim Across America, The Foundation for Barnes-Jewish Hospital
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 1 May 2023 (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 study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy, with a primary focus on outcomes in Black patients.
Detailed description
Risk category is defined as follows:
- Low risk:
- Baseline Ki67 ≤ 10% (OR)
- Luminal A molecular intrinsic subtype by PAM50
- High risk:
- Non-Luminal A molecular intrinsic subtype by PAM50 (OR)
- In cases of non-diagnostic PAM50 molecular intrinsic subtype, patients will enroll in the high-risk group and undergo Week 4 tumor biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk group | Experimental | Device: VENTANA MIB-1 Ki67 assay, Device: Oncotype DX® Recurrence Score, Device: PAM50-based Prosigna breast cancer gene signature assay, Drug: Anastrozole* Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50. * An additional blood draw for research purposes at Week 4 (no breast tumor biopsy at this time point) and continue to receive 5 additional 28-day cycles of anastrozole. * After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. |
| High-risk endocrine-sensitive group | Experimental | Device: VENTANA MIB-1 Ki67 assay, Device: Oncotype DX® Recurrence Score, Device: PAM50-based Prosigna breast cancer gene signature assay, Drug: Anastrozole* Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50. * An additional blood draw and breast tumor tissue collection at Week 4 to assess Ki67. Patients with Week 4 Ki67 ≤10% (the high-risk endocrine-sensitive group) will continue to receive 5 additional 28-day cycles of anastrozole. * After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. |
| High-risk endocrine-resistant group | Experimental | Device: VENTANA MIB-1 Ki67 assay, Device: Oncotype DX® Recurrence Score, Device: PAM50-based Prosigna breast cancer gene signature assay, Drug: Combination anthracycline and/or taxane based treatment* Baseline breast MRI and research specimen collection prior to the start of treatment with standard of care anastrozole. All patients will have one 28-day cycle of anastrozole, followed by determination of breast cancer risk category by incorporating results from baseline Ki67, Oncotype DX RS, and molecular intrinsic subtype by PAM50. * An additional blood draw and breast tumor tissue collection at Week 4 to assess Ki67. Patients with Week 4 Ki67 >10% (the high-risk endocrine-resistant group) will receive escalated therapy with ~5-6 additional months of standard of care chemotherapy (combination anthracycline- and/or taxane-based at the discretion of their physician). * After completion of ~6 months of neoadjuvant treatment, will undergo post-treatment breast MRI followed by standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed newly diagnosed clinical stage II or III (by AJCC 8th edition - at least T2, any N, M0 or if N1+ then any T) ER-positive (ER > 10%), any PR, and HER2-negative breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal.
- A palpable mass is not required; however, tumor size must be either:
- ECOG performance status 0 or 1.
- Eligible to receive neoadjuvant aromatase inhibitor, as per treating physician.
- Eligible to receive neoadjuvant standard of care anthracycline- and/or taxane-based chemotherapy regimen, as per treating physician.
Key exclusion criteria (15 listed)
- Inflammatory breast cancer (cT4d disease as per AJCC 8th edition).
- Locally recurrent or metastatic disease (cM1 disease as per AJCC 8th edition).
- Bilateral breast cancer.
- Prior systemic therapy for the indexed breast cancer.
- Pre-existing Grade ≥2 neuropathy.
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 |
|---|---|---|
| VENTANA MIB-1 Ki67 assayKi67 scoring determination (standard of care) utilizing the Ki67 MIB-1 assay (clone 30-9) (VENTANA) will be performed at baseline, Week 4 (+/- 14 days - high-risk group only), and at time of surgery in accordance with the International Ki67 in Breast Cancer Working Group guidelines. | Device | High-risk endocrine-resistant group, High-risk endocrine-sensitive group, Low-risk group |
| Oncotype DX® Recurrence ScoreOncotype DX® Recurrence Score (RS) testing - assessing expression of 21 genes including 16 cancer-related genes and 5 reference genes - will be performed as standard of care in a central laboratory (Exact Sciences) on RNA extracted from formalin-fixed paraffin-embedded core-biopsy samples. | Device | High-risk endocrine-resistant group, High-risk endocrine-sensitive group, Low-risk group |
| PAM50-based Prosigna breast cancer gene signature assayThis PAM50-based Prosigna breast cancer gene signature assay for intrinsic molecular subtype determination will be performed on formalin-fixed, paraffin-embedded (FFPE) core-biopsy samples. | Device | High-risk endocrine-resistant group, High-risk endocrine-sensitive group, Low-risk group |
| AnastrozoleStandard of care. All patients must start on anastrozole at time of enrollment but may switch to another aromatase inhibitor (letrozole or exemestane) due to toxicity or financial/other concerns at discretion of investigator after a discussion with the PI. Every effort to minimize interruption of aromatase inhibitor (AI) therapy is recommended. | Drug | High-risk endocrine-sensitive group, Low-risk group |
| Combination anthracycline and/or taxane based treatmentStandard of care | Drug | High-risk endocrine-resistant group |
Primary outcome
Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)
Time frame: Through completion of treatment (estimated to be 6 months)
* ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1. * Complete Response (CR): disappearance of all target and non-target lesions. Residual lesions thought to be non-malignant should be further investigated before CR can be accepted. * Partial Response (PR): ≥30% decrease in the sum of measures of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD.
4 secondary outcomes
Breast conservation surgery (BCS) conversion rate by cohort and treatment assignment
Time frame: Through completion of surgery (estimated to be 6 months)
Proportion of patients who will require oncoplastic breast reduction surgery before and after neoadjuvant treatment
Time frame: Through completion of surgery (estimated to be 6 months)
Objective response rate (ORR) by breast MRI in the high-risk endocrine-sensitive group
Time frame: Through completion of treatment (estimated to be 6 months)
Objective response rate (ORR) by breast MRI in the high-risk endocrine-resistant group (high risk patients with week 4 Ki67 > 10% post anastrozole)
Time frame: Through completion of treatment (estimated to be 6 months)
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 13 Apr 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.
Nusayba Bagegni, M.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 VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score and PAM50-based Prosigna breast cancer gene signature assay in people with Breast Cancer and Cancer of the 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 17 inclusion and 15 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 13 Apr 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 Nusayba A Bagegni, M.D. (314-273-3022, nbagegni@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders) (time frame: Through completion of treatment (estimated to be 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 13 Apr 2026.