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Hormone Therapy

Pre-Surgery Endocrine Therapy for Breast Cancer

N/A

Recruiting

Led By Minna Lee, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo upfront surgery

Women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to at least 2 weeks of endocrine therapy

Awards & highlights

Study Summary

This trial looks at changes in Ki67 expression after endocrine therapy in ER+/HER2- breast cancer patients pre-surgery. Results will compare BRCA2 carriers with non-carriers.

Who is the study for?

This trial is for women over 18 with stage I-III ER+/HER2- invasive breast cancer, scheduled for surgery and eligible for genetic testing. It's not open to those with a history of breast cancer, recent endocrine therapy for risk reduction, stage IV disease at presentation, or if pregnant.Check my eligibility

What is being tested?

The study examines the effect of endocrine therapy before surgery on Ki67 expression in breast tissue. Researchers will compare changes between BRCA2 mutation carriers and noncarriers after at least two weeks of treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, typical side effects from endocrine therapies may include hot flashes, fatigue, joint pain, mood swings, decreased sex drive and vaginal dryness.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for an initial surgery soon.

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I am a woman over 18 with early to mid-stage breast cancer that is ER+ and HER2-.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to at least 2 weeks of endocrine therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to at least 2 weeks of endocrine therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to at least 2 weeks of endocrine therapy for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

assess the change in Ki67

Trial Design

1Treatment groups

Experimental Treatment

Group I: Breast CancerExperimental Treatment2 Interventions

All study patients will receive standard ET for at least 2 weeks, which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,856 Total Patients Enrolled

202 Trials studying Breast Cancer

81,061 Patients Enrolled for Breast Cancer

Minna Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

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

Are new participants still being accepted into this trial?

"This clinical trial is actively recruiting patients, with the posting date appearing on 11/6/2023 and the most recent update occurring on 11/9/2023."

Answered by AI

What is the recruitment quota for this research?

"Affirmative. Clinicaltrials.gov hosts information confirming that this clinical trial is actively recruiting participants after being originally posted on November 6th 2023 and updated as recently as November 9th of the same year. 42 individuals are required to be recruited from 1 medical centre for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery

2023. "A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06127979.