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New treatment option for Breast Cancer
Official title NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
ClinicalTrials.gov ID: NCT05837455
What this study is testing
What is Anastrozole?
Anastrozole is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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 how well it works assessments of the indexed breast cancer. In this event, review and approval by the study PI is...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.