Estrogen Receptor-positive Breast CancerHER2-negative Breast CancerInvasive Ductal Breast CarcinomaInvasive Lobular Breast CarcinomaRecurrent Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Female ≥18 years of age
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. 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
4. Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
5. 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.
6. 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.
7. 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
8. 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.
9. Laboratory values (≤ 14 days prior to registration):
1. Absolute Neutrophil Count (ANC) \> 1000/mm\^3
2. Platelet Count \> 100,000/mm\^3
3. Total Bilirubin \< 1.5 x upper limits of normal (ULN)
4. Creatinine \< 1.5 x ULN
5. Serum alanine transaminase (ALT) \< 2.5 x ULN
10. 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:
1. Premenopausal status
2. 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).
3. An excisional biopsy of this breast cancer.
4. Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
5. Tumor estrogen receptor (ER) Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH \> 2.0.
6. Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
7. 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.
8. Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion.
9. Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
10. History of invasive breast cancer or contralateral DCIS.
Primary outcome measure(s)
Rate of endocrine resistant disease-(First Phase) — Up to 24 weeks
Recurrence-free survival (RFS)-(Second Phase) — Up to 5 years
Trial sites (860)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
University of South Alabama Mitchell Cancer Institute
Mobile
Alabama
Anchorage Associates in Radiation Medicine
Anchorage
Alaska
Anchorage Radiation Therapy Center
Anchorage
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Alaska Regional Hospital
Anchorage
Alaska
Alaska Women's Cancer Care
Anchorage
Alaska
Anchorage Oncology Centre
Anchorage
Alaska
Katmai Oncology Group
Anchorage
Alaska
Providence Alaska Medical Center
Anchorage
Alaska
University of Arizona Cancer Center at Saint Joseph's
Phoenix
Arizona
Mayo Clinic Hospital
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Yuma Cancer Center
Yuma
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
Highlands Oncology Group-Rogers
Rogers
Arkansas
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
East Bay Radiation Oncology Center
Castro Valley
California
Eden Hospital Medical Center
Castro Valley
California
Valley Medical Oncology Consultants-Castro Valley
Castro Valley
California
Community Cancer Institute
Clovis
California
University Oncology Associates
Clovis
California
Sutter Davis Hospital
Davis
California
Epic Care-Dublin
Dublin
California
Bay Area Breast Surgeons Inc
Emeryville
California
Epic Care Partners in Cancer Care
Emeryville
California
Kaiser Permanente-Fremont
Fremont
California
Palo Alto Medical Foundation-Fremont
Fremont
California
+ 820 more sites — see the full list on the official registry below.
More Alliance for Clinical Trials in Oncology trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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