← Back to Search

Hormone Therapy

Biomarker-Guided Neoadjuvant Therapy for Breast Cancer

Phase 2

Recruiting

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

Must not have

Locally recurrent or metastatic disease

Inflammatory breast cancer

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

My cancer is HER2 negative as confirmed by specific tests.

Select...

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

Select...

I am fully active or can carry out light work.

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I can undergo a breast MRI with contrast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has returned or spread to other parts of my body.

Select...

My condition is inflammatory breast cancer.

Select...

I have cancer in both of my breasts.

Select...

I have moderate to severe nerve damage.

Select...

I have received systemic therapy for my current breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Objective response rate (ORR) by breast MRI in the high-risk endocrine-resistant group (high risk patients with week 4 Ki67 > 10% post anastrozole)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 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.

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 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2016

Completed Phase 4

~5550

0 / 13Eligibility criteria met