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Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients


Inclusion Criteria:



- Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive
breast cancer who are eligible for and planning on starting treatment with an AI
within one month of signing consent.

- Postmenopausal, defined as at least one of the following: a) amenorrhea for at least
12 months b) prior bilateral oophorectomy at least 2 years prior to trial
registration.

Exclusion Criteria:

- History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus,
or other autoimmune conditions affecting joints.

- Treatment with steroid (for any condition, except for chemotherapy premedication)
within 30 days of trial registration.

- Prior treatment with an AI (patients previously or currently on tamoxifen are
eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood
draw)

- Active or ongoing infection

- Known metastatic disease

- Known history of HIV or hepatitis infections

- Ongoing radiation therapy (radiation must have been completed 2 weeks prior to
starting treatment with an AI)

- Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)

- Pregnant or lactating

- Unable to speak, read, and write in English

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.

Outcome Time Frame:

Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor

Safety Issue:

No

Principal Investigator

Sara Hurvitz, M D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

09-09-058

NCT ID:

NCT01051609

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Post Menopausal
  • Breast Cancer
  • Breast Neoplasms

Name

Location

UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California  90095