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Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole


N/A
N/A
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole


Inclusion Criteria:



- Postmenopausal female patients

- histological confirmed diagnosis of ER and/or PR positive breast cancer (Stage I-III)
who have completed local therapy

- Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months

- Willing to provide written informed consent to participate

- for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2

Exclusion Criteria:

- Known abnormal liver or renal function defined by:

1. Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or
Calculated Creatinine Clearance < 40 mL/min

2. Serum Bilirubin, AST or ALT > 1.5 times ULN

- Presence of persistent local or known metastatic cancer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Serum Estradiol at day 28

Outcome Time Frame:

baseline and day 28

Safety Issue:

No

Principal Investigator

Srikala Sridhar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai Hospital, New York

Authority:

Canada: Health Canada

Study ID:

AI Host Factors

NCT ID:

NCT01669343

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Aromatase Inhibitors
  • Breast Neoplasms
  • Neoplasms

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