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NeoTAILOR: Guiding Treatment for ER-positive, HER2-negative Breast Cancer

This study, called NeoTAILOR, is for women with newly diagnosed Stage II or III ER-positive (estrogen receptor positive, meaning the cancer grows in response to estrogen), HER2-negative breast cancer. It aims to find the best pre-surgery (neoadjuvant) treatment by looking at specific markers in your tumor. Researchers will use tests like the VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score, and PAM50-based Prosigna assay to help decide if you need chemotherapy or if hormone therapy like anastrozole alone might be enough. The goal is to improve how well treatment works and identify who might not need chemotherapy. The study is looking for about 81 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll about 81 women.
What's involved
You would have tests like the VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score, and PAM50-based Prosigna assay. You would also receive anastrozole and potentially combination anthracycline and/or taxane based treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, objective response rate, is measured through completion of treatment, estimated to be 6 months.

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NCT05837455

NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~81 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:VENTANA MIB-1 Ki67 assayOncotype DX® Recurrence ScorePAM50-based Prosigna breast cancer gene signature assayAnastrozoleCombination anthracycline and/or taxane based treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)
Measured over Through completion of treatment (estimated to be 6 months)

Conditions

Breast Cancer
Cancer of the Breast

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Nusayba Bagegni, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Nusayba A Bagegni, M.D.
[email protected]
314-273-3022
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Objective response rate (ORR) by breast MRI in the combined low-risk plus high-risk endocrine-sensitive groups (pooled endocrine therapy-responders)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.