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NCT06507618RECRUITINGIRB Ready

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

(POWER II)

Sponsored by University of Virginia

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 354 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a Phase III, multisite exploratory study for women โ‰ฅ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups: Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.

Who Can Participate

Inclusion Criteria

Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
ECOG performance status 0-2
Females, aged โ‰ฅ 65 years
Patient is eligible for BCS and opted for BCS
Patient is a candidate for radiation therapy
Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Bilateral synchronous breast cancer
Multicentric disease
Prior use of SERMS or aromatase inhibitors
History of ipsilateral breast radiation therapy
Has a known additional malignancy that is progressing and/or requires activ

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

354 participants

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Gender

FEMALE

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Sponsor

University of Virginia

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Charlottesville

Virginia

Location available
View Charlottesville location page
RECRUITING

Fairfax

Virginia

Location available
View Fairfax location page
RECRUITING

Richmond

Virginia

Location available
View Richmond location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Breast Cancer Treatment in Charlottesville?

Join others in Virginia exploring innovative treatment options through clinical research

Breast Cancer Treatment Options in Charlottesville, Virginia

If you're searching for Breast Cancer treatment in Charlottesville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Charlottesville, Fairfax, Richmond and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Breast Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Virginia
Now Enrolling
Up to 354 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Breast Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Breast Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Breast Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06507618. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.