Trial record 2 of 17 for:    denosumab AND breast cancer

Denosumab for Breast Cancer With Bone Mets

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01952054
First received: September 20, 2013
Last updated: May 11, 2015
Last verified: May 2015
  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.


Condition Intervention Phase
Breast Cancer
Drug: Denosumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Denosumab to Define the Role of Bone Related Biomarkers in Breast Cancer Bone Metastasis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Reduction of Circulating Tumor Cells (CTCs) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary endpoint is percentage of patients that have low circulating tumor cells (CTC), defined as less than 5 CTCs and also including CTC 0 in 7.5 ml whole blood. For the primary endpoint, McNemar's test will be applied to test the change of percentage of patients that are low CTCs over 4 weeks.


Estimated Enrollment: 35
Study Start Date: February 2015
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denosumab
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.
Drug: Denosumab
120 mg subcutaneously on Day 1 of every 28 day cycle.
Other Names:
  • AMG 162
  • Prolia

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 Cycle 2, you will also begin taking a hormonal drug every day. 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 Cycle 2:

  • 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 hvae soft tissue involvement (Lymph node and skin) and/or oligo-metastatic lesion 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.
  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: NCT01952054

Contacts
Contact: Naoto Ueno, MD, PHD 713-792-2817

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
Principal Investigator: Naoto Ueno, MD,PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01952054     History of Changes
Other Study ID Numbers: 2013-0007, NCI-2014-01273
Study First Received: September 20, 2013
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Breast carcinoma
Bone metastasis
Cancer that has spread to the bone
Denosumab
AMG 162
Prolia
Hormonal agent

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2015