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Hormone Therapy

Biomarker-Guided Neoadjuvant Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Nusayba Bagegni, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HER2 negative must be assessed by FISH or IHC staining 0 or 1+ according to ASCO/CAP guidelines

Histologically or cytologically confirmed newly diagnosed clinical stage II or III ER-positive, any PR, and HER2-negative breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of surgery (estimated to be 6 months)

Awards & highlights

Study Summary

This trial aims to improve breast cancer treatment for postmenopausal Black women and potentially reduce unnecessary chemo.

Who is the study for?

This trial is for postmenopausal women at least 18 years old with stage II/III ER-positive, HER2-negative breast cancer. Participants must have a tumor size ≥2 cm if lymph node negative, or any size with nodal involvement. They should be able to undergo MRI and tolerate neoadjuvant aromatase inhibitor therapy and chemotherapy.Check my eligibility

What is being tested?

The study tests a biomarker-driven approach using assays like VENTANA MIB-1 Ki67, Oncotype DX®, and PAM50 Prosigna to guide treatment selection in breast cancer patients. It compares the effectiveness of Anastrozole alone versus combined anthracycline/taxane treatments.See study design

What are the potential side effects?

Possible side effects include reactions related to hormone therapy such as hot flashes and joint pain from Anastrozole, and typical chemotherapy-related issues like nausea, fatigue, hair loss, increased infection risk from anthracycline/taxane.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is HER2 negative as confirmed by specific tests.

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My breast cancer is ER-positive, HER2-negative, and aims for surgery after initial treatment.

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I am fully active or can carry out light work.

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My tumor is at least 2 cm large and I don't have cancer in my lymph nodes.

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I am 18 years old or older.

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My cancer, which has spread to nearby lymph nodes, can be surgically removed.

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I can be treated with hormone therapy and standard chemotherapy before surgery.

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I can undergo a breast MRI with contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of surgery (estimated to be 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of surgery (estimated to be 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of surgery (estimated to be 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Breast conservation surgery (BCS) conversion rate by cohort and treatment assignment

Objective response rate (ORR) by breast MRI in the high-risk endocrine-resistant group

Objective response rate (ORR) by breast MRI in the high-risk endocrine-sensitive group

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low-risk groupExperimental Treatment4 Interventions

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.

Group II: High-risk endocrine-sensitive groupExperimental Treatment4 Interventions

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 biopsy 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.

Group III: High-risk endocrine-resistant groupExperimental Treatment4 Interventions

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 biopsy 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2019

Completed Phase 4

~10090

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,628 Total Patients Enrolled

46 Trials studying Breast Cancer

5,087 Patients Enrolled for Breast Cancer

The Foundation for Barnes-Jewish HospitalOTHER

37 Previous Clinical Trials

6,754 Total Patients Enrolled

6 Trials studying Breast Cancer

581 Patients Enrolled for Breast Cancer

Swim Across AmericaUNKNOWN

4 Previous Clinical Trials

104 Total Patients Enrolled

Media Library

Anastrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05837455 — Phase 2

Breast Cancer Research Study Groups: Low-risk group, High-risk endocrine-sensitive group, High-risk endocrine-resistant group

Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT05837455 — Phase 2

Anastrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837455 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for participants in this research study?

"According to clinicaltrials.gov, the recruitment phase of this trial has been concluded since April 18th 2023. However, there are presently 2,635 other studies actively looking for volunteers."

Answered by AI