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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Nusayba A Bagegni, M.D.
nbagegni@wustl.edu
314-273-3022
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 81
Treatments
Experimental: Low-risk group
* 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.
Experimental: High-risk endocrine-sensitive group
* 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.
Experimental: High-risk endocrine-resistant group
* 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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital, Swim Across America

This content was sourced from clinicaltrials.gov