Hormone Therapy for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must be taking: Anti-estrogen

Must not be taking: Strong CYP2D6 inhibitors

Disqualifiers: T4, N1-3, M1 breast cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

37 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a specific type of medication before surgery for patients with certain types of breast cancer. It aims to see how well the tumors respond by blocking estrogen, which helps some cancers grow. This approach helps doctors understand the treatment's effects better. A certain medication has shown to be effective in the treatment and prevention of breast cancer.

Research Team

Lubna N. Chaudhary

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for women over 18 with early-stage, node-negative breast cancer that's hormone receptor-positive and HER2-negative. They should be in good health with no other recent cancers (except certain types) or strong CYP2D6 inhibitors used. Participants must not be pregnant, have completed any prior breast cancer treatments two years ago, and agree to use contraception.

Inclusion Criteria

Your ALT and AST levels should be no more than three times the normal limit.

I am a woman aged 18 or older.

Your hemoglobin level is at least 9 grams per deciliter.

Exclusion Criteria

My breast cancer is advanced, affecting nearby lymph nodes or other parts of my body.

I am a man diagnosed with breast cancer.

I have no other cancers except for non-serious skin cancer or early-stage cervical cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Endocrine Therapy

Participants receive standard-of-care endocrine therapy preoperatively for four weeks to assess tumor response and molecular changes.

4 weeks

1 visit (in-person) for treatment initiation, followed by monitoring

Surgery

Participants undergo surgical resection of the tumor following the neoadjuvant endocrine therapy phase.

1 week

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery and treatment.

4 weeks

Treatment Details

Interventions

• Anastrozole
• Exemestane
• Letrozole
• Tamoxifen

Trial Overview The study tests the effects of starting standard anti-estrogen treatments like Anastrozole, Letrozole, Exemestane, or Tamoxifen before surgery. It's a preoperative intervention lasting four weeks to see how these drugs work when given earlier in treatment.

Participant Groups

Group I: Neoadjuvant endocrine therapy treatment (physician's choice) Experimental Treatment 4 Interventions

Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+