Know Cancer

forgot password

Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Phase 2
18 Years
74 Years
Not Enrolling
Breast Neoplasms, Breast Cancer

Thank you

Trial Information

Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Inclusion Criteria:

- Female patients suspected of having invasive breast cancer, >1 cm in diameter, and in
whom there is an indication for a core or incision biopsy

- Age <75 years at time of diagnosis

- Patient willing and able to comply with the study prescriptions

- Patient able to give written informed consent before patient

- Pre- and post-menopausal patients are eligible

- Hormone receptor positive and negative patients are eligible

- A negative pregnancy test in pre-menopausal women

Exclusion Criteria:

- HIV, HBV or HCV positivity

- Known hypersensitivity to NSAIDs

- A history of upper gastro-intestinal bleeding

- Endoscopically proven upper gastro-intestinal ulceration

- Patients using NSAIDs, including salicyclic acid

- Systemic use of corticosteroids

- A history or the presence of any other malignancy excepting adequately treated
squamous cell skin cancer or in situ carcinoma of the cervix

- Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

whole-genome expression after celecoxib treatment

Outcome Description:

Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues

Safety Issue:


Principal Investigator

Pierre SJ Hupperets, MD; PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Centre


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MUMC MEC 04-038



Start Date:

February 2004

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Celecoxib
  • Clinical trial, Phase II
  • Oligonucleotide Array Sequence Analysis
  • Breast Neoplasms
  • Neoplasms