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Exemestane and Cyclophosphamide for Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01963481
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
This phase II trial studies how well exemestane and cyclophosphamide work in treating patients with estrogen receptor (ER) -positive, progesterone receptor (PR) -positive, and human epidermal growth factor receptor (HER)2-negative stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Beast Cancer Drug: Exemestane Drug: Cyclophosphamide Phase 2

Detailed Description:
Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells. Low dose cyclophosphamide may also stimulate the white blood cells, including natural killer cells, for instance by decreasing the suppressor (regulatory) T-cells. Giving exemestane with cyclophosphamide may be an effective treatment for estrogen receptor-positive, progesterone receptor-positive, and HER2-negative stage IV breast cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Exemestane With Immunomodulatory Cyclophosphamide in ER and/or PR-positive and HER2/Neu Negative Metastatic Breast Cancer
Study Start Date : September 2013
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exemestane and cyclophosphamide

A treatment cycle is defined as 4 weeks:

One tablet (25 mg) of exemestane and one tablet (50 mg) of cyclophosphamide given daily by mouth until disease progression or unacceptable adverse events.

Drug: Exemestane
Other Name: Aromasin

Drug: Cyclophosphamide
Other Names:
  • Cytoxan
  • CTX

Primary Outcome Measures :
  1. Progression-free survival (PFS) rate at 3 months [ Time Frame: 3 months ]
    PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study.

Secondary Outcome Measures :
  1. Response rate (complete response and partial response) [ Time Frame: 2 years ]
    Evaluation of response is based on RESIST guideline version 1.1. Response is assessed every 12 weeks.

  2. Clinical benefit rate [ Time Frame: 3 years ]
    Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks. Evaluation of response and disease progression is based on RESIST guideline version 1.1. Response and progression are assessed every 12 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically confirmed breast cancer that is ER positive and/or PR positive, and HER2/neu negative and have disease that is metastatic (stage IV)

    • HER2/neu negative disease determined using commercially available/approved assay in local institutional or reference laboratory, according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (IHC 0-1+ or 2+ with HER2/17 ratio on FISH <= 1.8).
    • ER/PR expression performed by standard immunohistochemical assay and classified as ER and/or PR-positive according to ASCO/CAP guidelines (1-100% expression)
    • Histologic and/or cytologic confirmation of metastatic disease is encouraged whenever feasible, furthermore, if feasible, the biopsy should confirm that the metastatic tumor is ER and/or PR positive and HER2/neu negative. For patients in whom histologic biopsy confirmation and/or assessment of ER/PR/HER2 of metastatic disease is not feasible, it is required that the primary tumor be ER and/or PR-positive and HER2/neu negative.
  • Measurable disease (RECIST 1.1) or non-measurable (assessable) disease
  • Patients must have had progressive disease during at least one line of endocrine therapy for metastatic disease or have recurrent disease while or within 12 months of receiving adjuvant endocrine therapy. Prior treatments accepted include a non-steroidal aromatase inhibitor, tamoxifen, fulvestrant or combinations.
  • Patients taking bisphosphonates for bone disease are permitted to enter the trial, but their bone lesions are not considered to be assessable for response, although they are assessable for progression.
  • Female or male subjects age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Patients must have normal organ and marrow function as defined below:

    • absolute neutrophil count >= 1,200/mcL
    • platelets >= 100,000/mcL
    • hemoglobin >= 9g/dl
    • total bilirubin <= 2 X upper limit of normal (ULN) [unless due to Gilbert's disease]
    • AST(SGOT) <= 2.5 X ULN
    • ALT(SGPT) <= 2.5 X ULN
    • creatinine <= 1.5 X ULN
  • Patients must be able to swallow and tolerate oral medications.
  • Postmenopausal status, defined as 60 years and older, being 45 years and older and having amenorrhea x 12 months or follicle stimulating hormone levels within postmenopausal range, OR having undergone a bilateral oophorectomy.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • Prior treatment for breast cancer with a steroidal aromatase inhibitor; with the exception of patients who were started on the combination of exemestane with everolimus less than 4 weeks prior to study entry and discontinued everolimus due to poor tolerability.
  • Presence of life threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread) or uncontrolled brain metastases.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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 identifier (NCT number): NCT01963481

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United States, New York
NYU Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
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Principal Investigator: Sylvia Adams, MD NYU Perlmutter Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: New York University School of Medicine Identifier: NCT01963481     History of Changes
Other Study ID Numbers: 13-00761
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
hormonal therapy

Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists