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Hormone Therapy
Hormone Therapy for Breast Cancer (POWER II Trial)
Phase 3
Recruiting
Led By Shayna L Showalter, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
Females, aged ≥ 65 years
Must not have
Prior use of SERMS or aromatase inhibitors
Bilateral synchronous breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to study the treatment of early-stage estrogen receptor positive breast cancer in women aged 65 and above. Participants will be randomly assigned to one of two groups: one group will receive 3
Who is the study for?
This trial is for women aged 65 or older with early stage estrogen receptor positive (ER+) breast cancer. Participants will either receive pre-operative endocrine therapy or follow standard care before surgery.
What is being tested?
The study compares the effects of taking Tamoxifen, Letrozole, Anastrozole, or Exemestane for three months before surgery versus proceeding directly to surgery without these drugs in women with ER+ breast cancer.
What are the potential side effects?
Potential side effects from the medications may include hot flashes, joint pain, fatigue, mood changes, and a small risk of blood clots. Side effects vary depending on the specific drug taken.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for hormone therapy for my cancer.
Select...
I am a woman aged 65 or older.
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I am eligible for and have chosen breast-conserving surgery.
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I can take pills and will follow hormone therapy for 3 months before surgery.
Select...
My breast cancer is ER positive, may or may not be PR positive, and is HER2 negative without spread to lymph nodes.
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I can take care of myself and am up and about more than half of the day.
Select...
I am eligible for radiation therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously used SERMS or aromatase inhibitors.
Select...
I have cancer in both breasts at the same time.
Select...
I have had radiation therapy on the same side breast before.
Select...
I am using or will use a strong medication that affects liver enzyme CYP2D6 and cannot switch to another therapy.
Select...
My cancer is present in multiple locations within the same organ.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET
Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)
Secondary study objectives
Assessing whether early side effects of ET correlate with patient treatment group within study arms
Assessing whether patient's final treatment correlates with their beliefs about breast cancer
Assessing whether treatment with pre-ET leads to improved Health Related Quality of Life compared to those treated with standard of care
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
90 days of pre-ET (endocrine therapy - tamoxifen or aromatase inhibitor) before Breast Cancer Surgery
Group II: Control ArmActive Control1 Intervention
Will proceed directly to Breast Cancer Surgery
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,092 Total Patients Enrolled
11 Trials studying Breast Cancer
2,142 Patients Enrolled for Breast Cancer
Shayna L Showalter, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
83 Total Patients Enrolled