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

Running, not enrolling · Phase 3

Conditions studied: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Recurrent Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

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.

Key facts

Study ID: NCT01953588
Run by: Alliance for Clinical Trials in Oncology
People needed: 1473
Starts: 2014-02-27
Expected to finish: 2027-04-01
Last updated by the study team: 2026-06-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Postmenopausal, verified by:
post bilateral surgical oophorectomy or
no spontaneous menses ≥ 1 year or
no menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
Clinical T2-T4c, any N, M0 invasive breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node. Primary tumor must be:
palpable
its largest diameters is at least 2.0 cm by physical examination or by radiological assessment
Note:
Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible.
Patients with multi-centric breast cancer (defined as more than one lesion is invasive breast cancer in the same breast separated by ≥ 2 cm of normal breast tissue are not eligible.
Invasive breast cancer is estrogen receptor positive with an Allred score of 6, 7 or 8 by local institution standard protocol. If an Allred Score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible. If ER positivity is ≤ 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred Score to determine eligibility.
Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2)- A patient is considered to have HER2 negative breast cancer if one of the following applies:
0 or 1+ by immunohistochemistry (IHC) and ISH not done
0 or 1+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
Documentation of mammogram and ultrasound (including ductal carcinoma in situ (DCIS) and invasive cancer) of the diseased breast performed within 56 days prior to registration. Mammogram for the unaffected contralateral breast is required within 12 months prior to registration.
Laboratory values (≤ 14 days prior to registration):
Absolute Neutrophil Count (ANC) > 1000/mm\^3
Platelet Count > 100,000/mm\^3
Total Bilirubin < 1.5 x upper limits of normal (ULN)
Creatinine < 1.5 x ULN
Serum alanine transaminase (ALT) < 2.5 x ULN

You may not qualify if…

Premenopausal status
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d' orange without erythema).
An excisional biopsy of this breast cancer.
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
Tumor estrogen receptor (ER) Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0.
Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
Clinical or radiographic evidence of metastatic disease. Metastatic workup is not required, but is recommended for patients with clinical stage III disease. Note: Isolated ipsilateral supraclavicular node involvement is permitted.
Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion.
Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
History of invasive breast cancer or contralateral DCIS.

Where it is running

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

Full record on ClinicalTrials.gov

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