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

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01953588 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:


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.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Daniel Morganstern, MD, Faulkner Hospital

Site-responsible Investigators:
Steven Come, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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. 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) Note: - Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible. - Patients with multifocal/multi-lesional breast cancer are not eligible if more than one lesion is invasive breast cancer in the same breast. 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) 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. 8. Documentation of mammogram and ultrasound (including ductal carcinoma in situ (DCIS) and invasive cancer) of the diseased breast performed within 42 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 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. Patients who have previously had implants removed within 6 weeks prior to registration are eligible. 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.
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