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Study record managers: refer to the Data Element Definitions if submitting registration or information.

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This clinical trial was deed 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. Surgical findings at weeks post neoadjuvant endocrine therapy are such that:. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Talk with your doctor and family members or friends about deciding to a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. 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:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : July 20, Study Description.

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.

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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.

Show detailed description. Hide detailed description. Detailed Description:. Note that this objective will only be tested if the selected fulvestrant arm was shown to be superior to anastrozole in objective 1 or 2. To examine the differences in surgical outcome, clinical and radiological response rates, and safety profile between the fulvestrant arm and the anastrozole arm.

To examine the differences in surgical outcome, clinical and radiological response rates, and safety profile between patients randomized to fulvestrant in combination with anastrozole and those randomized to anastrozole. To examine the rate of pathologic complete response pCR of 12 weeks of neoadjuvant paclitaxel in patients with endocrine resistant disease following 4 weeks or 12 weeks of neoadjuvant endocrine therapy with either fulvestrant or anastrozole or the combination of fulvestrant and anastrozole.

MedlinePlus related topics: Breast Cancer. Drug Information available for: Anastrozole Fulvestrant. FDA Resources. Arms and Interventions. Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles followed by surgery. Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles followed by surgery. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Primary tumor must be: palpable its largest diameters is at least 2. Invasive breast cancer is estrogen receptor positive with an Allred score of 6, 7 or 8 by local institution standard protocol. Mammogram for the unaffected contralateral breast is required within 12 months prior to registration. An excisional biopsy of this breast cancer. Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.

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. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. J Clin Oncol. Epub Jan 3. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Drug: fulvestrant Drug: anastrozole. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :.

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Active Comparator: Arm I anastrozole Patients receive anastrozole daily for 6 cycles followed by surgery. Active Comparator: Arm II fulvestrant Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles followed by surgery. Active Comparator: Arm III anastrozole and fulvestrant Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles followed by surgery. Colorado Springs, Colorado, United States, Greenwood Village, Colorado, United States, Washington, District of Columbia, United States, Springfield, Massachusetts, United States, Farmington Hills, Michigan, United States, Sterling Heights, Michigan, United States, Heartland Hematology and Oncology Associates Incorporated.

Sainte Genevieve, Missouri, United States, Greenville, North Carolina, United States, Hendersonville, North Carolina, United States, Hillsborough, North Carolina, United States, Huntersville, North Carolina, United States, Jacksonville, North Carolina, United States, Kenansville, North Carolina, United States, Mooresville, North Carolina, United States, Statesville, North Carolina, United States, East Stroudsburg, Pennsylvania, United States, Hershey, Pennsylvania, United States, Murtha Regional Cancer Center. State College, Pennsylvania, United States, Wilkes-Barre, Pennsylvania, United States, Charleston, South Carolina, United States, Greenville, South Carolina, United States, Spartanburg, South Carolina, United States, University of Vermont and State Agricultural College.

Hematology Oncology Associates of Fredericksburg Inc. Spokane Valley, Washington, United States, Wisconsin Rapids, Wisconsin, United States, October 1, Key Record Dates.

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