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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of starting hormone therapy before breast cancer surgery. It focuses on anti-estrogen treatments, which stop the growth of cancer cells that rely on estrogen. Medications such as Anastrozole, Exemestane, Letrozole, and Tamoxifen will be used, selected by a medical oncologist based on the patient's medical history. Women with early-stage, estrogen- or progesterone-receptor-positive breast cancer who have not recently received treatment may be eligible to participate. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot use strong CYP2D6 inhibitors. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that anastrozole, exemestane, letrozole, and tamoxifen are generally safe for patients.

Research shows that anastrozole significantly reduces the chance of breast cancer recurrence and is well-tolerated over time. It also lowers the risk of developing breast cancer in high-risk women.

Exemestane has proven effective and safe, with fewer side effects than tamoxifen. It also reduces the risk of developing invasive breast cancer in postmenopausal women.

Letrozole has demonstrated positive results in long-term safety studies, lowering the risk of new breast cancer cases. It is considered safe for extended use.

Tamoxifen significantly reduces the risk of breast cancer and has been used safely for many years, cutting the risk of developing invasive breast cancer by about half.

These treatments are standard options for breast cancer care, with a strong history of safety. Participants can feel confident that these treatments have been well-studied and are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the hormone therapies Anastrozole, Exemestane, Letrozole, and Tamoxifen because they offer a tailored approach to breast cancer treatment. These therapies are part of a neoadjuvant endocrine therapy strategy, allowing doctors to choose the most suitable option based on a patient's unique medical history and menstrual status. This personalized approach not only optimizes treatment effectiveness but also prepares patients for surgery by potentially shrinking tumors beforehand. By targeting hormone receptors specifically, these treatments can be more effective and have fewer side effects compared to traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that letrozole and anastrozole outperform tamoxifen in treating early breast cancer. Letrozole offers slightly better survival rates than anastrozole. Exemestane also proves more effective than tamoxifen for high-risk premenopausal women. In this trial, participants will receive neoadjuvant endocrine therapy, with the medical oncologist deciding the treatment—either aromatase inhibitors like letrozole, anastrozole, and exemestane, or tamoxifen. Aromatase inhibitors generally reduce the chance of cancer recurrence by about 30% compared to tamoxifen. While tamoxifen remains a viable option for some patients, aromatase inhibitors often yield better results. ^{1 6 7 8 9}

Who Is on the Research Team?

Lubna N. Chaudhary

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 bilirubin level in the blood is not too high.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2001225/

A decade of letrozole: FACE - PMC Conclusions. Letrozole and anastrozole have both demonstrated superior efficacy compared with tamoxifen as initial therapy for early breast cancer [3, 4].

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2802824

Efficacy of Alternative Dose Regimens of Exemestane in ... In the adjuvant-treatment setting, exemestane has shown greater efficacy than tamoxifen in high-risk premenopausal women in association with ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.69.2871

Comparative Efficacy and Safety of Adjuvant Letrozole ... The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2690973/

Long-term efficacy and safety of anastrozole for adjuvant ... The results of the Oxford meta-analyses3,4 have demonstrated significant reduction in both disease recurrence (41%) and breast cancer specific mortality (34%) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0140673615610741

Aromatase inhibitors versus tamoxifen in early breast cancer Aromatase inhibitors reduce recurrence rates by about 30% (proportionately) compared with tamoxifen while treatments differ, but not thereafter.

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(19)32955-1/fulltext

Use of anastrozole for breast cancer prevention (IBIS-II) Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase ...

7. news.cancerresearchuk.org news.cancerresearchuk.org/2023/11/07/anastrozole-licensed-prevent-breast-cancer-high-risk-women/

Thousands of women offered anastrozole to help prevent ... These results showed that 5-year treatment with anastrozole has continued long-term effect in preventing breast cancer in these high-risk groups ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.044750

Aromatase Inhibitors and the Risk of Cardiovascular ... These drugs have been associated with favorable clinical outcomes, including decreased risks of all-cause and breast cancer–related mortality, ...

9. breastcancer.org breastcancer.org/research-news/risk-reducing-effects-of-arimidex-last-years

Risk-Reducing Effects of Arimidex for High- ... The new results show that women who took Arimidex were 50% less likely to be diagnosed with breast cancer than women who didn't take Arimidex.