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NCT01953588 · ClinicalTrials.gov registry record · Phase 3
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
A Phase 3 study of HER2-Negative Breast Cancer and Stage II Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 1,473
- Enrollment target
- 20
- Study locations
NCT01953588 is a Phase 3 study of HER2-Negative Breast Cancer and Stage II Breast Cancer that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,473 participants, above the 225-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (555% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT01953588, a Phase 3 study of HER2-Negative Breast Cancer and Stage II Breast Cancer, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,473 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.
Conditions Studied
Interventions
- DRUG fulvestrant
- DRUG anastrozole
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- University of Arizona Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
- Yuma Cancer Center - Yuma
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,473 participants |
| Start Date | 2014-02-27 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01953588
The ClinicalTrials.gov registry entry for NCT01953588 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,473 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 225-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (555% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which fulvestrant is the first listed.
NCT01953588 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01953588 about?
NCT01953588 is a clinical study titled "Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery". The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the le...
What is the current status of trial NCT01953588?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,473 participants. The study started on 2014-02-27. Estimated completion is 2027-04-01.
What conditions does trial NCT01953588 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.
What interventions are being tested in trial NCT01953588?
The interventions under investigation include: fulvestrant (DRUG), anastrozole (DRUG).
Who is sponsoring clinical trial NCT01953588?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01953588 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.