Clinical Trials /

Denosumab for Breast Cancer With Bone Mets

NCT01952054

Description:

The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone. The safety of this combination will also be studied. This is an investigational study. Denosumab is FDA approved and commercially available to prevent bone-related events caused by breast cancer that has spread to the bone. Using denosumab to lower CTCs in patients with breast cancer that has spread to the bone is investigational. You may have the option of continuing denosumab after the study ends. Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Denosumab for <span class="go-doc-concept go-doc-disease">Breast Cancer</span> With Bone Mets

Title

  • Brief Title: Denosumab for Breast Cancer With Bone Mets
  • Official Title: Phase II Study of Denosumab to Define the Role of Bone Related Biomarkers in Breast Cancer Bone Metastasis
  • Clinical Trial IDs

    NCT ID: NCT01952054

    ORG ID: 2013-0007

    NCI ID: NCI-2014-01273

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Denosumab AMG 162, Prolia Denosumab

    Trial Purpose

    The goal of this clinical research study is to learn if denosumab in combination with a
    hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with
    breast cancer that has spread to the bone. The safety of this combination will also be
    studied.

    Detailed Description

    Study Drug Administration:

    If you are found to be eligible to take part in this study, you will receive denosumab
    through a needle under your skin on Day 1 of each 28-day study cycle.

    Starting on Day 1 of week 4, you will also begin taking a hormonal drug. The study doctor
    will choose the hormonal drug you receive based on your previous hormonal therapy for breast
    cancer. The study doctor will give you instructions for taking your hormonal drug.

    Study Visits:

    On Day 1 of week 4:

    - You will have a physical exam

    - Blood (about 3 tablespoons) will be drawn for routine tests

    - Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune
    system.

    - Urine will be collected to test for a biomarker that is used to measure the rate of
    bone breakdown.

    - If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an
    MRI to check the status of the disease.

    On Day 1 of Cycle 2 and Cycle 3, blood (about 1 teaspoon) will be drawn for routine tests.

    Length of Study:

    You may receive the denosumab and hormonal therapy combination for up to 13 weeks. You will
    be taken off study if the disease gets worse or intolerable side effects occur.

    End of Study Visit:

    After your last dose of the study drug, the following tests and procedures will be
    performed:

    - You will have a physical exam.

    - Blood (about 3 tablespoons) will be drawn for routine tests.

    - Blood (about 5 teaspoons) will be drawn for CTC testing and to check your immune
    system.

    - Urine will be collected to test for a biomarker that is used to measure the rate of
    bone breakdown.

    - If the study doctor thinks it is needed, you will have a PET scan, a bone scan, or an
    MRI to check the status of the disease.

    This is an investigational study. Denosumab is FDA approved and commercially available to
    prevent bone-related events caused by breast cancer that has spread to the bone. Using
    denosumab to lower CTCs in patients with breast cancer that has spread to the bone is
    investigational.

    Up to 35 patients will take part in this study. All will be enrolled at MD Anderson.

    Trial Arms

    Name Type Description Interventions
    Denosumab Experimental Participants receive a single subcutaneous (SC) administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, in addition to receiving Denosumab every 4 weeks, participants receive a hormonal agent. Each physician can choose hormonal agent, but exclude the agent that the participants received at adjuvant therapy setting. Denosumab

    Eligibility Criteria

    Inclusion Criteria:

    1. Patients have histological confirmation of breast carcinoma.

    2. Patients have metastatic disease with predominantly bone metastasis with 2 or more
    lesions and have not been treated. Patients can have soft tissue involvement (Lymph
    node and skin) and/or metastatic lesions at major organ sites (i.e. lung, liver,
    etc).

    3. Patients have positive ER expression in the primary tumor site by IHC (defined as
    >/=10%) (PR status is not required)

    4. Adequate hematologic function: 1)Absolute neutrophil count (ANC) >/= 1.0 x 10^9/L, 2)
    Platelet count >/= 50 x 10^9/L, 3) Hemoglobin >/= 9.0 g/dL

    5. Adequate cardiac function (LVEF >/= 45%)

    6. Adequate Renal function: Calculated creatinine clearance >30 ml/min

    7. Adequate Hepatic function: 1) Aspartate aminotransferase (AST) </= 2.5 x ULN; 2)
    Alanine aminotransferase (ALT) </= 2.5 x ULN; 3) Alkaline phosphatase (Alp) </= 2.5 x
    ULN; 4) Total bilirubin </= 2.0 x ULN

    8. Serum calcium or albumin-adjusted serum calcium >/=2.0mmol/L (8.0mg/dL) and </= 2.9
    mmol/L (11.5mg/dL)

    9. Patients have ability and willingness to sign written informed consent.

    10. Patients are 18 years of age or older.

    11. Female patients of childbearing potential (A female not free from menses > 2 years or
    not surgically sterilized) must be willing to use highly effective contraception to
    prevent pregnancy or agree to abstain from heterosexual activity throughout the
    study. Highly effective contraception, defined as male condom with spermicide,
    diaphragm with spermicide, intra-uterine device. Highly effective contraception must
    be used by both sexes during the study and must be continued for 5 months after the
    last dose of denosumab.

    12. Female patients of childbearing potential must have negative serum pregnancy test </=
    21 days prior to starting study treatment.

    13. Patients have CTC >/=3.

    Exclusion Criteria:

    1. Patients have known sensitivity to any of the products to be administered during the
    study (e.g., mammalian derived products, calcium, or vitamin D).

    2. Patients receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy,
    radiation therapy and biological therapy) while taking study medication. However,
    patients receiving CDK4 inhibitor while on study is permitted.

    3. Patients with metastatic sites that requires chemotherapy and/or non-hormonal
    targeted therapy.

    4. Patients with active infection and requiring IV or oral antibiotics.

    5. Patients with concurrent disease or condition that would make them inappropriate for
    study participation, or any serious medical disorder that would interfere with
    patients' safety.

    6. Patients have HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene
    amplification by FISH)

    7. Patient is pregnant or breast feeding, or planning to become pregnant within 5 months
    after the end of treatment.

    8. Patient is of child bearing potential and is not willing to use, in combination with
    her partner, two highly effective methods of contraception or abstinence during
    treatment and for 5 months after the end of treatment.

    9. Male patients.

    10. Patients have prior history or current evidence of osteonecrosis/osteomyelitis of the
    jaw.

    11. Patients have active dental or jaw condition which requires oral surgery, including
    tooth extraction.

    12. Patients have non healed dental/oral surgery, including tooth extraction.

    13. Patients planned invasive dental procedures.

    14. Patients experiencing a visceral crisis including severe organ dysfunction as
    assessed by > Gr 2 symptomatic toxicities, laboratory studies, and/ or rapid
    progression of disease originating from visceral metastasis.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Reduction of Circulating Tumor Cells (CTCs)

    Secondary Outcome Measures

    Trial Keywords

    Breast cancer

    Breast carcinoma

    Bone metastasis

    Cancer that has spread to the bone

    Denosumab

    AMG 162

    Prolia

    Hormonal agent