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
Overview
- Phase
- Phase 2
- Intervention
- Naproxen
- Conditions
- Bone Pain in Stage I - III Breast Cancer
- Sponsor
- Amgen
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Bone Pain (All Grades) in Cycle 1
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
Eligibility Criteria
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
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
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
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
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
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
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Intervention: Pegfilgrastim
No prophylactic treatment
Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Intervention: Chemotherapy
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))