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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Bone Pain in Stage I - III Breast Cancer

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bone pain (all grade) in cycle 1

Outcome Description:

To estimate the difference in cycle 1 bone pain (all grade) between treatment groups (naproxen, loratadine, or no therapy) captured as part of adverse event (AE) reporting

Outcome Time Frame:

Will be assessed 30 days after all subjects complete chemotherapy

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20110147

NCT ID:

NCT01712009

Start Date:

November 2012

Completion Date:

August 2014

Related Keywords:

  • Bone Pain in Stage I - III Breast Cancer
  • Breast cancer
  • Chemotherapy
  • Neulasta
  • Pegfilgrastim
  • Naproxen
  • Loratadine
  • Non-steroidal antiinflammatory drug (NSAID)
  • Anti-histamine
  • Bone Pain
  • Breast Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteHooksett, New Hampshire  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBend, Oregon  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin