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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study
 
Region Sponsors
California - Northern
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
CN-15-2267-C
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Women with Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Cancer; Stage II, IIIA, IIIB, IIIC Breast Cancer
 
Purpose
This randomized phase III trial has several primary objectives. One primary objective is to compare the efficacy of 3 different endocrine therapies, the estrogen receptor down regulator fulvestrant and the aromatase inhibitor anastrozole, either alone or in combination, in reducing cancer growth before surgery (neoadjuvant) in postmenopausal women with clinical stage II-III estrogen receptor positive and HER2 negative breast cancer. Another primary objective is to evaluate whether patients who achieved a modified PEPI (Preoperative Endocrine Prognostic Index) score of 0, defined by tumor size <5 cm, N0, Ki67<2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy predict excellent long term outcome, for whom chemotherapy is unnecessary.
 
Detailed Description
Patients will be randomized to one of three treatment groups: anastrozole, fulvestrant or the combination of anastrozole and fulvestrant. Each cycle is 28 days for a total of 6 cycles. Surgery must be performed between days 15-28 of Cycle 6 in each treatment arm. Patients who are determined to have an endocrine resistant tumor at week 4 or week 12 will discontinue endocrine protocol therapy. It is recommended that patients be switched to neoadjuvant treatment. After completion of surgery, those with a modified preoperative endocrine prognostic index (PEPI) score of 0 will continue assigned endocrine treatment for 4.5 years and those with a non-zero PEPI score will receive adjuvant chemotherapy +/- endocrine therapy chosen by treating physician.
 
Gender Age Limit
Female 18 years & older
 
Inclusion Criteria
  • 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. The extent of disease is a solitary lesion where the lesion is: palpable, its size can be measured bidimensional by tape, ruler or caliper technique, and its largest tumor diameter is at least 2.0 cm (that is considered measurable by the WHO criteria)
  • 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) negative defined as 0 or 1+ by immunohistochemistry (IHC) or with a fluorescence in situ hybridization (FISH) ratio (HER2 gene copy/chromosome 17) < 2 if IHC 2+ by local institution standard protocol.
 
Exclusion Criteria
  • 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. Patients who have previously had implants removed within 6 weeks prior to registration are eligible
  • 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.

 
Keywords and/or Specific Medical Conditions
  • Females - Postmenopausal
  • Estrogen Receptor Modulators
  • Fulvestrant
  • Estrogens
  • A011106
  • Hormone Antagonists
  • Adenocarcinoma
  • Hormones
  • Anastrozole
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Antineoplastic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents, Hormonal
  • Neoplasms
  • Aromatase Inhibitors
  • Neoplasms by Histologic Type
  • Breast Diseases
  • Neoplasms by Site
  • Breast Neoplasms
  • Neoplasms, Ductal, Lobular, and Medullary
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Carcinoma, Ductal
  • Pharmacologic Actions
  • Carcinoma, Ductal, Breast
  • Physiological Effects of Drugs
  • Carcinoma, Lobular
  • Skin Diseases
  • Enzyme Inhibitors
  • Therapeutic Uses
  • Estradiol
  • Oncology (Adult)
  • Estrogen Antagonists
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Antioch
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- Desiree Goldstein
-desiree.goldstein@kp.org
-Vallejo Medical Center


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