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

Key

Inclusion Criteria:

- Age 18 years or older

- ECOG performance status 0-2

- Female with newly diagnosed, chemo-naive stage I-III breast cancer

- Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy,
pegfilgrastim, naproxen and loratadine as determined by investigator

- Creatinine ≤ 1.5 X upper limit of normal

- Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy

- Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and
continuing throughout each chemotherapy cycle of the treatment period

- Other criteria may apply

Key Exclusion Criteria:

- History of other malignancy within past 5 years

- History of clinically significant bleeding disorders, thromboembolism within 6 months

- Currently enrolled in another investigational device or drug study

- Planning to receive weekly chemotherapy

- Ongoing chronic pain, or other painful conditions requiring treatment

- Chronic steroid use

- Chronic use of (NSAIDs) or anti-histamines outside of those dictated by randomization
groups

- Prior use of granulocyte-colony stimulating factor (G-CSF)

- History of clinically significant gastrointestinal (GI) bleeding, history of GI
ulcers or active GI bleeding within 6 months prior to randomization

- Other criteria may apply