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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: Active Phase 3 study of HER2-Negative Breast Cancer and Stage II Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT01953588 still lists
NCT01953588 is an interventional study that assigns participants to a tested intervention. Its 1,473 participants enrollment target places it among the larger protocols in the corpus, above the 225-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (555% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01953588's enrollment target sits among peer trials
1,473 2nd of 49 the highest of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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