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Clinical Trials in Mexico / NCT01953588
Active, not recruiting Phase 3

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

NCT01953588 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2014-02-27
Last updated
2026-06-05

Condition(s) studied

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

Investigational drug(s) / intervention(s)

fulvestrant →anastrozole →

fulvestrant: Fulvestrant 500 mg IM

anastrozole: Anastrozole 1 mg oral tablet

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.

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)

Trial sites (860)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT01953588 on ClinicalTrials.gov ↗ ← All trials in Mexico