Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Amgen255 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

255

Conditions

Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer

Interventions

DenosumabBIOLOGICAL

Denosumab administered by subcutaneous injection

IV BisphosphonatesDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma * At least one bone metastasis

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and Week 13

Secondary Outcomes

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

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

Time frame: Baseline and Week 25

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

Time frame: Baseline and Week 13

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

Time frame: Baseline and Week 25

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

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.

Time frame: Baseline to Week 57

Data from ClinicalTrials.gov

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

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.

Time frame: Baseline and week 13

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

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

Time frame: Baseline and Week 25

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

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

Time frame: Baseline and Week 13

Percent Change From Baseline to Week 25 in P1NP

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.

Time frame: Baseline and Week 25

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

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

Time frame: Baseline and Week 13

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

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

Time frame: Baseline and Week 25

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

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

Time frame: Baseline and Week 13

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

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

Time frame: Baseline and Week 25

Percent Change From Baseline to Week 13 in Osteocalcin

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

Time frame: Baseline and Week 13

Percent Change From Baseline to Week 25 in Osteocalcin

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

Time frame: Baseline and Week 25

Time to First Skeletal Related Event

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).

Time frame: Day 1 to Week 25

Number of Participants With Skeletal Related Events

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).

Time frame: From Day 1 to Week 25

Number of Participants With Hypercalcemia

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.

Time frame: Day 1 to Week 57