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Selective Estrogen Receptor Downregulator

Fulvestrant vs Tamoxifen for Breast Cancer

N/A

Waitlist Available

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

Postmenopausal female patients

Renal criteria: Creatinine ≤ 2.0 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing two drugs to see which is better at treating postmenopausal women with breast cancer.

Who is the study for?

This trial is for postmenopausal women with a specific type of breast cancer called ductal carcinoma in situ (DCIS), who haven't had previous treatments and are planning to have surgery. They must be generally healthy, with recent mammography, normal blood counts, kidney and liver function within certain limits, no severe medical or psychiatric conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing two hormone therapies: fulvestrant and tamoxifen. These drugs may block estrogen which can help breast cancer grow. The goal is to see how well these drugs work when given before surgery to treat DCIS in postmenopausal women.See study design

What are the potential side effects?

Fulvestrant and tamoxifen might cause side effects like hot flashes, joint pain, nausea, fatigue, mood swings, vaginal dryness or discharge. Rarely they can lead to more serious issues such as blood clots or changes in vision.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman who has gone through menopause.

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My creatinine level is 2.0 mg/dL or lower.

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I have never had a pulmonary embolism.

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I do not have severe numbness or pain in my hands or feet.

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My breast cancer is confirmed as DCIS.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver function tests are within acceptable limits.

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My disease was recently confirmed with a small tissue sample.

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I have never had a deep vein thrombosis.

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I have biopsy tissue available for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

Secondary outcome measures

Mammographic breast density as measured by the Madena method at 3 weeks

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,757 Total Patients Enrolled

16 Trials studying Breast Cancer

2,024 Patients Enrolled for Breast Cancer

Agustin Garcia, MDStudy ChairCedars-Sinai Medical Center

11 Previous Clinical Trials

199 Total Patients Enrolled

2 Trials studying Breast Cancer

80 Patients Enrolled for Breast Cancer

Media Library

Frequently Asked Questions

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

Are new participants being enrolled in this experiment?

"According to the data found on clinicaltrials.gov, this medical research is no longer actively enrolling patients as its last update was November 5th 2013. Nonetheless, there are currently 3888 other studies that remain open for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast

2004. "Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00126464.

All > Basal Cell Carcinoma > Breast