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Completed

NCT Number: NCT00091832

Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

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Key information

Conditions

Breast Cancer Bone Metastases in Subjects With Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Histologically or cytologically confirmed breast adenocarcinoma

  • At least one bone metastasis

Treatment and study plan

Denosumab

Biological

Denosumab administered by subcutaneous injection

Other names: AMG 162

IV Bisphosphonates

Drug

Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

Primary outcomes

  1. Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)

    Time frame: Baseline and Week 13

    Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

Secondary outcomes

  1. Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

  2. Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13

    Time frame: Baseline and Week 13

    The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.

  3. Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25

    Time frame: Baseline and Week 25

    The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.

  4. Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline

    Time frame: Baseline to Week 57

    Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.

  5. Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)

    Time frame: Baseline and week 13

    Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

  6. Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

  7. Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)

    Time frame: Baseline and Week 13

    Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

  8. Percent Change From Baseline to Week 25 in P1NP

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.

  9. Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)

    Time frame: Baseline and Week 13

    Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

  10. Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

  11. Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)

    Time frame: Baseline and Week 13

    Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

  12. Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

  13. Percent Change From Baseline to Week 13 in Osteocalcin

    Time frame: Baseline and Week 13

    Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

  14. Percent Change From Baseline to Week 25 in Osteocalcin

    Time frame: Baseline and Week 25

    Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

  15. Time to First Skeletal Related Event

    Time frame: Day 1 to Week 25

    Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

  16. Number of Participants With Skeletal Related Events

    Time frame: From Day 1 to Week 25

    Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

  17. Number of Participants With Hypercalcemia

    Time frame: Day 1 to Week 57

    Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Sep 21, 2004
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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