ALTernate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
ALTernate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant TrEatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
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.
This clinical trial was designed to examine the pathologic outcomes of patients whose neoadjuvant treatment course is determined using an early marker of endocrine resistance (namely, Ki67 after 4 or 12 weeks of neoadjuvant therapy) as well as assessing clinical outcome of patients whose disease burden after completing neoadjuvant endocrine therapy is classified as Modified PEPI 0.
The primary and secondary objectives for the study are described below.
Primary Objectives:
Secondary Objectives:
Inclusion Criteria:
Female ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Postmenopausal, verified by:
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:
Note:
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:
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):
Tissue acquisition: Patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies.
Exclusion Criteria:
Jonesboro, Arkansas 72401, United States
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Pleasant Hill, California 94523, United States
Roseville, California 95661, United States
San Pablo, California 94806, United States
Vacaville, California 95687, United States
Englewood, Colorado 80113, United States
Highland Park, Illinois 60035, United States
Pekin, Illinois 61554, United States
Baltimore, Maryland 21237, United States
East China, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Macomb, Michigan 48044, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
Columbus, Mississippi 39705, United States
New Albany, Mississippi 38652, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Huntersville, North Carolina 28078, United States
Mooresville, North Carolina 28117, United States
Wpafb, Ohio 45433-5529, United States
Charleston, South Carolina 29414, United States
Lancaster, South Carolina 29720, United States
Spartanburg, South Carolina 29307, United States
Houston, Texas 77030, United States
Berlin Corners, Vermont 05602, United States
Yakima, Washington 98902, United States
Summit, Wisconsin 53066, United States