Trial record 1 of 1 for:    A011106
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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01953588
First received: September 25, 2013
Last updated: June 10, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Lobular Breast Carcinoma
Recurrent Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: fulvestrant
Drug: anastrozole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Rate of endocrine resistant disease-(First Phase) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Pathologic complete response rate-(pCR rate) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Recurrence-free survival (RFS)-(Second Phase) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2820
Study Start Date: December 2013
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (anastrozole)
Patients receive anastrozole daily for 6 cycles followed by surgery. 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.
Drug: anastrozole
Anastrozole 1 mg oral tablet
Other Name: Arimidex®
Active Comparator: Arm II (fulvestrant)
Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. 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.
Drug: fulvestrant
Fulvestrant 500 mg IM
Other Name: Faslodex®
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 2-6 followed by surgery. 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.
Drug: fulvestrant
Fulvestrant 500 mg IM
Other Name: Faslodex®
Drug: anastrozole
Anastrozole 1 mg oral tablet
Other Name: Arimidex®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join 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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953588

Contacts
Contact: Cynthia Ma, MD, PhD 314-362-9383

  Show 509 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Cynthia Ma, MD, PhD Washington University School of Medicine
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01953588     History of Changes
Other Study ID Numbers: A011106  NCI-2013-01340  U10CA031946 
Study First Received: September 25, 2013
Last Updated: June 10, 2016
Health Authority: United States: NCI Central Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Fulvestrant
Anastrozole
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016