NOLAN: Naproxen or Loratadine and Neulasta
Condition: Bone Pain in Stage I - III Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Naproxen; Loratadine; Pegfilgrastim; Chemotherapy
Intervention description: Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.; The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Intervention MeSH terms: Loratadine; Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Breast cancer; Chemotherapy; Neulasta; Pegfilgrastim; Naproxen; Loratadine; Non-steroidal antiinflammatory drug (NSAID); Anti-histamine; Bone Pain

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.
    

Eligibility criteria:

        Age 18 years or over

          -  Eastern cooperative oncology group (ECOG) performance status 0-2

          -  Female with newly diagnosed, not previously treated with chemotherapy, stage I-III
             breast cancer

          -  Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy,
             pegfilgrastim, naproxen and loratadine as determined by the investigator

          -  Creatinine ≤ 1.5 X upper limit of normal (ULN)

          -  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

          -  Subject has provided informed consent

        Exclusion Criteria

          -  History of other malignancy within the past 5 years, with the following exceptions:

               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
                  of disease

               -  Adequately treated cervical carcinoma in situ without evidence of disease

          -  Planning to receive weekly chemotherapy

          -  Ongoing chronic pain, or other painful conditions requiring treatment (including
             immediate post-operative treatment of surgical or procedural-associated pain) as
             determined by the investigator

          -  Chronic oral steroid use. Premedication related to the administration of chemotherapy,
             and use of anti-emetics is allowed, per usual clinical practice

          -  Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral
             antihistamines outside of those dictated by the randomization groups outlined in the
             protocol, with the following exception:

             - Chronic oral aspirin use for cardiovascular-related indications

          -  Prior chemotherapy treatment for cancer within 5 years of current breast cancer
             diagnosis

          -  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

          -  History of clinically significant bleeding disorders, thromboembolism within 6 months
             prior to randomization

          -  Currently enrolled in, or less than 30 days since ending, another clinical trial which
             includes language directing G-CSF (filgrastim, pegfilgrastim, other) or
             granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use

          -  Currently enrolled in, or less than 30 days since ending, another interventional
             clinical trial which includes a blinded treatment or blinded treatment arm (whether or
             not the subject is randomized to the blinded arm)

          -  Currently enrolled in, or less than 30 days since ending, another interventional
             clinical trial which includes the use of any agent not currently considered to be
             standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast
             cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice
             Guidelines in Oncology for Breast Cancer

          -  Currently enrolled in, or less than 30 days since ending, any pain intervention study

          -  Female subjects who are pregnant or lactating or of reproductive potential not willing
             to employ an effective method of birth control during treatment and for 17 days after
             discontinuing study treatment

          -  History or evidence of any other clinically significant disorder, condition or disease
             (with the exception of those outlined above) that, in the opinion of the Investigator
             or Amgen, if consulted, would pose a risk to subject safety or interfere with the
             study evaluation, procedures or completion