Trial Title:
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
NCT ID:
NCT05837455
Condition:
Breast Cancer
Cancer of the Breast
Conditions: Official terms:
Breast Neoplasms
Anastrozole
Taxane
Conditions: Keywords:
breast cancer
postmenopausal women
Ki67
PAM50 subtype
breast cancer disparities
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
VENTANA MIB-1 Ki67 assay
Description:
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.
Arm group label:
High-risk endocrine-resistant group
Arm group label:
High-risk endocrine-sensitive group
Arm group label:
Low-risk group
Intervention type:
Device
Intervention name:
Oncotype DX® Recurrence Score
Description:
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.
Arm group label:
High-risk endocrine-resistant group
Arm group label:
High-risk endocrine-sensitive group
Arm group label:
Low-risk group
Intervention type:
Device
Intervention name:
PAM50-based Prosigna breast cancer gene signature assay
Description:
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.
Arm group label:
High-risk endocrine-resistant group
Arm group label:
High-risk endocrine-sensitive group
Arm group label:
Low-risk group
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
Standard of care
Arm group label:
High-risk endocrine-sensitive group
Arm group label:
Low-risk group
Intervention type:
Drug
Intervention name:
Combination anthracycline and/or taxane based treatment
Description:
Standard of care
Arm group label:
High-risk endocrine-resistant group
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 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.
Criteria for eligibility:
Criteria:
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.
- Tumor size ≥2 cm in one dimension by clinical or radiographic examination (WHO
criteria), if clinically axillary lymph node negative. Patients with histologically
confirmed resectable locoregional nodal involvement may enroll regardless of tumor
size. A palpable mass is not required as long as the mass is at least 2 cm in one
dimension by radiographic exam.
- 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 exception of basal cell or squamous cell carcinoma of the skin which were
treated with local resection only or adequately treated carcinoma in situ of the
cervix.
- Concurrent participation in any investigational therapeutic trial for treatment of
breast cancer.
- Contraindication to breast MRI, such as:
- Prior allergic reaction to gadolinium-based MR contrast agents.
- Renal insufficiency (glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2)
measured within the past 60 days which precludes safe administration of the
contrast agent.
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nusayba A Bagegni, M.D.
Phone:
314-273-3022
Email:
nbagegni@wustl.edu
Investigator:
Last name:
Nusayba A Bagegni, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Cynthia X Ma, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Emily L Podany, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Weilbaecher, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Debbie L Bennett, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
John Olson, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Glover-Collins, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Fouad Boulos, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ian Hagemann, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jingqin (Rosy) Luo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Carolina Salvador, M.D.
Email:
Sub-Investigator
Start date:
May 30, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Swim Across America
Agency class:
Other
Collaborator:
Agency:
The Foundation for Barnes-Jewish Hospital
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05837455
http://www.siteman.wustl.edu
