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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 14-002616
    • Rochester, Minnesota: 14-002616
    NCT ID: NCT01953588
    Sponsor Protocol Number: A011106

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tina Hieken, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Tina Hieken, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions