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NCT02188745 · ClinicalTrials.gov registry record · Phase 2
ER Reactivation Therapy for Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 3
- Study locations
NCT02188745 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 19 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT02188745, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 3
- Study locations
Study Summary
Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems counterintuitive since anti-estrogens block ER function, while estrogens increase ER function, but these therapies are effective to similar extents for the treatment of metastatic ER+ breast cancer. Estrogen therapies are most effective against cancers that develop resistance to anti-estrogens, likely because such cancers have adapted to grow without ER function, and restoring ER function (with estrogen) is damaging to the cancer cells. In some patients with ER+ breast cancer that becomes resistant to anti-estrogens, treatment with the estrogen 17B-estradiol induces tumor response. Furthermore, when 17B-estradiol-sensitive tumors eventually become resistant to 17B-estradiol, switching back to anti-estrogen therapy is often effective. These observations suggest that cancers can alternate between anti-estrogen-sensitive and 17B-estradiol-sensitive states. The investigators hypothesize that treatment with alternating 17B-estradiol / anti-estrogen therapies on a defined 8-week / 16-week schedule will more effectively prevent cancer growth than continuous treatment with either type of therapy in patients with metastatic anti-estrogen-resistant ER+ breast cancer.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG 17B-estradiol
Study Locations (3)
Massachusetts
- Baystate Medical Center - Springfield
Minnesota
- Mayo Clinic Cancer Center - Rochester
New Hampshire
- Dartmouth Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-03-11 |
| Est. Completion | 2024-07-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02188745
The ClinicalTrials.gov registry entry for NCT02188745 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Anastrozole is the first listed.
NCT02188745 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Minnesota, New Hampshire.
Frequently Asked Questions
What is clinical trial NCT02188745 about?
NCT02188745 is a clinical study titled "ER Reactivation Therapy for Breast Cancer". Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor (ER)-positive breast cancer, high-dose estrogen therapies were used. This seems counterintuitive since anti-estrogens block ER function, while estrogens increase ER function, but these therapies are effective to simila...
What is the current status of trial NCT02188745?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2016-03-11. Estimated completion is 2024-07-05.
What conditions does trial NCT02188745 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT02188745?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), 17B-estradiol (DRUG).
Who is sponsoring clinical trial NCT02188745?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02188745 being conducted?
This trial has 3 study locations across Massachusetts, Minnesota, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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