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Hormone Therapy
ER Reactivation Therapy for Breast Cancer (POLLY Trial)
Phase 2
Waitlist Available
Led By Mary Chamberlin, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women ≥18 years of age with clinical stage IV ER+/HER2- breast cancer, or with locally recurrent ER+/HER2- disease not amenable to therapy for curative intent
HER2-negative status is defined as immunohistochemistry score of 0-1+, or with a FISH ratio of <2 if IHC is 2+ or if IHC has not been done (as per ASCO/CAP definitions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
POLLY Trial Summary
This trial is testing whether treatment with a combination of the estrogen 17B-estradiol and the anti-estrogen tamoxifen, given on an 8-week / 16-week schedule, is more effective than treatment with either 17B-estradiol or tamoxifen alone in preventing the growth of metastatic anti-estrogen-resistant ER+ breast cancer.
Who is the study for?
This trial is for post-menopausal women over 18 with advanced ER+/HER2- breast cancer resistant to anti-estrogens. They must have had prior anti-estrogen treatment, possibly one chemotherapy line, and a recurrence-free interval of at least 2 years if treated in the adjuvant setting. Participants need proper organ function and no CNS disease or other serious health issues.Check my eligibility
What is being tested?
The study tests alternating high-dose estrogen (17B-estradiol) with aromatase inhibitors (Anastrozole, Exemestane, Letrozole) against metastatic breast cancer that's become resistant to standard treatments. The hypothesis is that switching between these therapies will prevent cancer growth more effectively than continuous single therapy.See study design
What are the potential side effects?
Potential side effects include typical reactions to hormone therapies such as hot flashes, mood swings, vaginal dryness or bleeding, joint pain, osteoporosis risk increase; and from biopsies like pain or infection at the biopsy site.
POLLY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 with advanced ER+/HER2- breast cancer or local ER+/HER2- cancer that cannot be cured.
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My cancer is not HER2 positive based on specific tests.
Select...
I am eligible for treatment with estrogen and aromatase inhibitors.
Select...
My cancer did not return for at least 2 years after my last treatment.
Select...
My cancer is strongly estrogen receptor positive.
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I am post-menopausal, either through surgery or haven't had a period for over a year.
POLLY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit
Secondary outcome measures
Adverse event profiles
Objective response rate
Predictive tumor genetic lesions
+1 moreSide effects data
From 2013 Phase 2 trial • 643 Patients • NCT0011451720%
urinary tract infection
15%
arthralgia
15%
cervical dysplasia
14%
influenza
11%
fall
11%
back pain
8%
cough
8%
drug hypersensitivity
7%
sinusitis
7%
chest discomfort
6%
vulvovaginal pruritis
6%
road traffic accident
6%
non-cardiac chest pain
6%
bronchitis
5%
rash
5%
contusion
5%
depression
5%
vaginal discharge
3%
pain in extremity
2%
breast cancer
2%
breast cancer in situ
1%
pulmonary embolism
1%
unstable angina
1%
colorectal cancer
1%
uterine cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
17B-estradiol
POLLY Trial Design
1Treatment groups
Experimental Treatment
Group I: Alternating TherapyExperimental Treatment4 Interventions
Study will use an 8-week/16-week alternating regimen of 17B-estradiol/AI (aromatase inhibitor) therapy. Use of only one Aromatase inhibitor throughout the study is preferred.
17B-estradiol: One tablet containing 2 mg 17B-estradiol will be taken orally three times daily, for a total dose of 6 mg/day.
Letrozole: One tablet containing 2.5 mg letrozole will be taken orally once per day.
Anastrozole: One tablet containing 1 mg anastrozole will be taken orally once per day.
Exemestane: One tablet containing 25 mg exemestane will be taken orally once per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2019
Completed Phase 4
~10300
Exemestane
2003
Completed Phase 4
~7880
Letrozole
2002
Completed Phase 4
~3240
17B-estradiol
2004
Completed Phase 2
~650
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,320 Total Patients Enrolled
29 Trials studying Breast Cancer
2,352,830 Patients Enrolled for Breast Cancer
Mary Chamberlin, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
5 Previous Clinical Trials
209 Total Patients Enrolled
Gary N Schwartz, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
6 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide fresh tumor samples from a recent biopsy for research.Before starting the study treatment, your recent blood and organ function tests need to show certain levels: Hemoglobin should be higher than 9 g/dL, white blood cell count should be 2,000/uL or more, platelet count should be 75,000/uL or more, creatinine should be less than 1.5 times the upper limit of normal, total bilirubin should be less than 1.5 times the upper limit of normal, and ALT and AST should be less than 3 times the upper limit of normal (for patients with liver spread, less than 5 times the upper limit of normal).You need to have had specific imaging tests to see how far the cancer has spread.I have been treated with fulvestrant in the last 16 weeks.My breast cancer is ER positive and HER2 negative, confirmed by a biopsy in the last 4 months.I am not on any other cancer treatments during this study.I have been treated with anti-estrogen therapy for my cancer.I have had one round of chemotherapy for my advanced cancer.My cancer is not HER2 positive based on specific tests.I am eligible for treatment with estrogen and aromatase inhibitors.My last treatment for advanced cancer kept it from worsening for at least 3 months.I am a woman over 18 with advanced ER+/HER2- breast cancer or local ER+/HER2- cancer that cannot be cured.My brain condition has been stable for at least 3 months.I have breast cancer that has spread to my bones, and it was ER+ and HER2-.My cancer did not return for at least 2 years after my last treatment.I am willing and able to sign the consent form for this study.My cancer is strongly estrogen receptor positive.I have a history of serious heart issues, stroke, or cancer with high recurrence risk.I am post-menopausal, either through surgery or haven't had a period for over a year.My cancer matches the ER and HER2 criteria but can't be safely biopsied.I have had hormone therapy for my cancer, regardless of how many times.I am allowed to use medications for bone strength.I have extra tumor tissue samples available for research.You have taken any experimental cancer treatment in the past 3 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Alternating Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you inform me of any other research projects which have incorporated 17B-estradiol?
"As of now, 241 clinical trials involving 17B-estradiol are active with 61 in their third phase. Most of these research initiatives centre around Shanghai, but there are 15104 sites globally running investigations related to this medication."
Answered by AI
Is 17B-estradiol a safe hormone for human consumption?
"Although there is limited evidence on the efficacy of 17B-estradiol, prior clinical research provides sufficient data to rate its safety as a 2."
Answered by AI
How has 17B-estradiol been traditionally employed therapeutically?
"17B-estradiol is often prescribed for patients suffering from advanced androgen dependent prostate cancer. This medication can also be utilized to treat no menstrual period in previous 6 months, hypoestrogenism, as well as vasomotor symptoms associated with menopause."
Answered by AI
Is entry into this research study still available to individuals?
"At the present moment, this research project is not accepting patients. It was initially published on March 11th 2016 and last updated November 1st 2022. For those searching for alternatives, there are presently 2297 clinical trials recruiting individuals with breast cancer and 241 studies actively admitting people who need 17B-estradiol treatment."
Answered by AI
How many participants are being selected for this research project?
"This medical experiment has now closed its recruitment window. Initially posted on March 11th 2016, it was most recently updated on November 1st 2022. For other opportunities, there are presently 2297 trials for breast cancer and 241 studies involving 17B-estradiol actively recruiting patients."
Answered by AI
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