Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Study Overview
Brief Summary
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
Detailed Description
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.
Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Naproxen (Drug)
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Pegfilgrastim (Biological)
Prophylactic naproxen
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Chemotherapy (Drug)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Loratadine (Drug)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Pegfilgrastim (Biological)
Prophylactic loratadine
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
Intervention: Chemotherapy (Drug)
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Intervention: Pegfilgrastim (Biological)
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Bone Pain (All Grades) in Cycle 1
Time Frame: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)
Bone pain data were captured as part of standard adverse event (AE) reporting.
Secondary Outcomes
- Maximum Patient-reported Bone Pain by Cycle and Across Cycles(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))
- Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles(Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval))
- Area Under the Curve (AUC) for Patient-reported Bone Pain(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))
- Number of Participants With Adverse Events (AEs)(From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.)
- Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles(Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval))
- Mean Patient-reported Bone Pain by Cycle and Across Cycles(Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle))