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Hormone Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Lubna Chaudhary

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Female; age ≥18 years.

Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at four weeks.

Awards & highlights

Study Summary

This trial is testing a new way to give anti-estrogen treatment to women with breast cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from the anti-estrogen medications may include hot flashes, joint pain, fatigue, mood swings, decreased sex drive and bone density loss. Each drug has its own profile of possible side effects which can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged 18 or older.

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I have been diagnosed with early-stage breast cancer.

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My organ functions are within normal ranges.

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My tumor is positive for estrogen or progesterone.

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I am able to get out of my bed or chair and move around.

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My doctor has approved me for hormone therapy for cancer.

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I finished treatment for cancer in my other breast over two years ago.

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My cancer is HER2 negative according to tests.

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I haven't had cancer treatment in the last 2 years, except for certain skin cancers, cervical pre-cancer, or cancer in my other breast.

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My lymph nodes do not have cancer, confirmed by exams and imaging.

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I am not taking any strong medications that affect liver enzyme CYP2D6.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at four weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at four weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at four weeks. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.

Secondary outcome measures

Number of Subjects Who Achieve Complete Radiographic Response.

Number of Subjects Who Achieve a Partial Radiographic Response.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant endocrine therapy treatment (physician's choice)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

FDA approved

Letrozole

FDA approved

Exemestane

FDA approved

Tamoxifen

FDA approved

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

608 Previous Clinical Trials

1,162,460 Total Patients Enrolled

12 Trials studying Breast Cancer

409,206 Patients Enrolled for Breast Cancer

Lubna ChaudharyPrincipal InvestigatorMedical College of Wisconsin

Media Library

Breast Cancer Research Study Groups: Neoadjuvant endocrine therapy treatment (physician's choice)

Breast Cancer Clinical Trial 2023: Exemestane Highlights & Side Effects. Trial Name: NCT03219476 — Phase 2

Frequently Asked Questions

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

How many individuals are allowed to enroll in this clinical trial?

"This study is not presently enrolling patients. The listing was first created on February 5th, 2017 and updated September 22nd, 2020. For other active trials, there are currently 2700 clinical studies for breast cancer and 234 for Tamoxifen that are admitting new participants."

Answered by AI

What are the common benefits of Tamoxifen?

"malignant neoplasms is commonly treated with Tamoxifen. Tamoxifen is also effective at treating other conditions including ovarian cancer, breast cancer, and high risk."

Answered by AI

What is the typical patient experience with Tamoxifen?

"While Phase 2 trials don't have efficacy data, there is some safety evidence for Tamoxifen. Therefore, it received a score of 2."

Answered by AI

What are the goals that we hope to achieve with this experiment?

"The key metric that will be evaluated four weeks after treatment starts is the increase in HER protein levels. Other measures of success include the number of subjects who achieve partial or complete radiographic response, as defined by World Health Organization (WHO) criteria."

Answered by AI

Could you give me a rundown of other research done on Tamoxifen?

"Out of the 234 ongoing studies that involve Tamoxifen, 66 are in Phase 3. While some trials take place in Shanghai, there are 16109 different locations around the world where researchers are studying this medication."

Answered by AI

Can new patients still join this clinical trial?

"Unfortunately, this particular clinical trial is not presently enrolling patients. Although, there are 2934 other active trials that might be a better match for you. This study was first posted on February 5th, 2017 and was last updated on September 22nd, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer

Lubna Chaudhary 2017. "Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03219476.

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