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New trial aims to tailor breast cancer therapy using genetic tests

NCT ID NCT05837455

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether using specific genetic tests (Ki67 and Oncotype DX) can help doctors choose the best treatment before surgery for women with a common type of breast cancer (ER-positive, HER2-negative). The study includes 81 postmenopausal women with stage II or III disease and focuses on improving outcomes for Black patients. The goal is to see if this personalized approach can increase tumor shrinkage and identify women who may not need chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ki67 assay and Oncotype DX test (diagnostic devices to guide treatment choice)
What this could lead to
If successful, this approach could help personalize breast cancer treatment, potentially sparing some women from chemotherapy and improving response rates, especially for Black patients.
What could go wrong
This is a small, early-phase trial (81 participants) testing a strategy, not a new drug. The biomarker approach may not improve outcomes as hoped, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 81 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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