Trial record 1 of 1 for:    NCT01953588
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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 March 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01953588
First received: September 25, 2013
Last updated: March 5, 2014
Last verified: March 2014
  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.


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: Factorial 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 - (Neo-adjuvant Phase) [ Time Frame: 7 years from study opening ] [ Designated as safety issue: No ]
  • Recurrence-free survival (RFS) - (Post surgery Phase) [ Time Frame: 8.5 to 11 years from study opening ] [ Designated as safety issue: No ]
  • Pathologic complete response rate - (pCR rate) [ Time Frame: 7 years from study opening ] [ Designated as safety issue: No ]

Estimated Enrollment: 2820
Study Start Date: December 2013
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (anastrozole)
Patients receive anastrozole 1 mg daily by mouth, Days 1-28, every 4 weeks for 6 cycles
Drug: anastrozole
Anastrozole 1 mg oral tablet
Other Name: Arimidex®
Active Comparator: Arm II (fulvestrant)
Patients receive fulvestrant 500 mg IM, Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-6, every 4 weeks for 6 cycles
Drug: fulvestrant
Fulvestrant 500 mg IM
Other Name: Faslodex®
Active Comparator: Arm III (anastrozole and fulvestrant)
Patients receive anastrozole 1 mg daily by mouth, Days 1-28, every 4 weeks for 6 cycles and fulvestrant 500 mg IM, Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-6, every 4 weeks for 6 cycles.
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
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. 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.
  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/mm3
    2. Platelet Count > 100,000/mm3
    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.
  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

  Show 138 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Cynthia Ma, M.D., Ph.D. Washington University School of Medicine
  More Information

No publications provided

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: March 5, 2014
Health Authority: United States: Food and Drug Administration
United States: NCI Central Institutional Review Board

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

ClinicalTrials.gov processed this record on October 28, 2014