81 Participants Needed

Biomarker-Guided Neoadjuvant Therapy for Breast Cancer

Nusayba Bagegni, M.D. profile photo
Overseen ByNusayba Bagegni, M.D.
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
Must be taking: Aromatase inhibitors
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is anastrozole generally safe for humans?

Anastrozole, also known as Arimidex, has been shown to be generally well-tolerated and safe for postmenopausal women with breast cancer, with fewer gynecologic side effects compared to tamoxifen.12345

How is the drug Anastrozole combined with anthracycline and taxane different from other breast cancer treatments?

This treatment is unique because it combines Anastrozole, a drug that lowers estrogen levels, with chemotherapy drugs like anthracyclines and taxanes, which attack cancer cells directly. This combination targets hormone-sensitive breast cancer more effectively by using both hormonal and chemotherapy approaches, potentially improving outcomes compared to using these treatments separately.46789

What data supports the effectiveness of the drug Anastrozole for breast cancer treatment?

Research shows that Anastrozole is more effective than Tamoxifen in improving disease-free survival and reducing the risk of tumor recurrence in postmenopausal women with early-stage breast cancer. It also has a better safety profile, with fewer side effects like vaginal bleeding and hot flushes.347910

Who Is on the Research Team?

Nusayba A. Bagegni, MD - Washington ...

Nusayba Bagegni, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My cancer is HER2 negative as confirmed by specific tests.
My breast cancer is ER-positive, HER2-negative, and aims for surgery after initial treatment.
I am fully active or can carry out light work.
See 8 more

Exclusion Criteria

Uncontrolled intercurrent illness that would limit compliance with study requirements
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
My cancer has returned or spread to other parts of my body.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant treatment with anastrozole for approximately 6 months, with risk category assessment and potential escalation to chemotherapy for high-risk endocrine-resistant group

6 months
Baseline MRI, Week 4 assessment, post-treatment MRI

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Anastrozole
  • Combination anthracycline and/or taxane based treatment
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Low-risk groupExperimental Treatment4 Interventions
Group II: High-risk endocrine-sensitive groupExperimental Treatment4 Interventions
Group III: High-risk endocrine-resistant groupExperimental Treatment4 Interventions

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Arimidex for:
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Approved in United States as Arimidex for:
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Approved in Canada as Arimidex for:
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Approved in Japan as Arimidex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Swim Across America

Collaborator

Trials
11
Recruited
410+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials
43
Recruited
6,600+

Swim Across America

Collaborator

Trials
8
Recruited
290+

Published Research Related to This Trial

In a study of 6241 postmenopausal women with early-stage breast cancer, anastrozole was found to have significantly fewer treatment-related adverse events compared to tamoxifen, indicating better tolerability.
Anastrozole also demonstrated a more favorable risk-benefit profile, with lower rates of serious adverse events and recurrence compared to tamoxifen, making it a preferable option for adjuvant treatment.
Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial.Buzdar, A., Howell, A., Cuzick, J., et al.[2022]
In a study of 97 postmenopausal women with hormone receptor-positive breast cancer, neoadjuvant anastrozole showed a significantly higher histopathological response rate (35.4%) compared to tamoxifen (12.2%), indicating greater effectiveness in shrinking tumors before surgery.
The study also found that anastrozole led to more changes in estrogen and progesterone receptor status, with 5 out of 40 patients becoming ER-negative and 16 out of 17 becoming PgR-negative, suggesting a stronger impact on hormone receptor activity compared to tamoxifen.
Histopathological assessment of anastrozole and tamoxifen as preoperative (neoadjuvant) treatment in postmenopausal Japanese women with hormone receptor-positive breast cancer in the PROACT trial.Kurosumi, M., Takatsuka, Y., Watanabe, T., et al.[2022]
Anastrozole is a potent and selective third-line aromatase inhibitor that offers a significant advancement in the treatment of hormone-sensitive breast cancer, particularly for postmenopausal women.
This review highlights anastrozole's biochemical properties and clinical efficacy, indicating its widespread use as a first- and second-line treatment option, potentially providing better outcomes and safety compared to traditional therapies like tamoxifen.
Anastrozole: pharmacological and clinical profile in postmenopausal women with breast cancer.Köberle, D., Thürlimann, B.[2018]

Citations

Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. [2022]
Histopathological assessment of anastrozole and tamoxifen as preoperative (neoadjuvant) treatment in postmenopausal Japanese women with hormone receptor-positive breast cancer in the PROACT trial. [2022]
Anastrozole: pharmacological and clinical profile in postmenopausal women with breast cancer. [2018]
Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: results of a North American multicenter randomized trial. Arimidex Study Group. [2022]
Anastrozole: in early breast cancer. [2018]
A lower incidence of gynecologic adverse events and interventions with anastrozole than with tamoxifen in the ATAC trial. [2018]
Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the Tamoxifen or Arimidex Randomized Group Efficacy and Tolerability study. [2022]
Role of anastrozole in adjuvant therapy for postmenopausal patients. [2019]
Concurrent administration of chemo-endocrine therapy for postmenopausal breast cancer patients. [2018]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Comparison of neoadjuvant adriamycin and docetaxel versus adriamycin, cyclophosphamide followed by paclitaxel in patients with operable breast cancer. [2021]
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