๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-04

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery (NCT01953588)

ALTernate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Alliance for Clinical Trials in Oncology

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham Cancer Center โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (860 Sites)

Showing the first 25 of 860 sites.

  • University of Alabama at Birmingham Cancer Center โ€” Birmingham, Alabama
  • University of South Alabama Mitchell Cancer Institute โ€” Mobile, Alabama
  • Anchorage Associates in Radiation Medicine โ€” Anchorage, Alaska
  • Anchorage Radiation Therapy Center โ€” Anchorage, Alaska
  • Alaska Breast Care and Surgery LLC โ€” Anchorage, Alaska
  • Alaska Oncology and Hematology LLC โ€” Anchorage, Alaska
  • Alaska Regional Hospital โ€” Anchorage, Alaska
  • Alaska Women's Cancer Care โ€” Anchorage, Alaska
  • Anchorage Oncology Centre โ€” Anchorage, Alaska
  • Katmai Oncology Group โ€” Anchorage, Alaska
  • Providence Alaska Medical Center โ€” Anchorage, Alaska
  • University of Arizona Cancer Center at Saint Joseph's โ€” Phoenix, Arizona
  • Mayo Clinic Hospital โ€” Phoenix, Arizona
  • Mayo Clinic in Arizona โ€” Scottsdale, Arizona
  • Banner University Medical Center - Tucson โ€” Tucson, Arizona
  • University of Arizona Cancer Center-North Campus โ€” Tucson, Arizona
  • Yuma Cancer Center โ€” Yuma, Arizona
  • Mercy Hospital Fort Smith โ€” Fort Smith, Arkansas
  • CHI Saint Vincent Cancer Center Hot Springs โ€” Hot Springs, Arkansas
  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro โ€” Jonesboro, Arkansas
  • Highlands Oncology Group-Rogers โ€” Rogers, Arkansas
  • Kaiser Permanente-Deer Valley Medical Center โ€” Antioch, California
  • PCR Oncology โ€” Arroyo Grande, California
  • Sutter Auburn Faith Hospital โ€” Auburn, California
  • Sutter Cancer Centers Radiation Oncology Services-Auburn โ€” Auburn, California

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Estrogen Receptor-positive Breast Cancer

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—