Status:

UNKNOWN

Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer

Lead Sponsor:

Fudan University

Conditions:

Breast Cancer

Hypoxia

Eligibility:

FEMALE

60-90 years

Brief Summary

The aim of our current study was to analyze whether 18F-labeled Fluoromisonidazole (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane \[18F-FMISO\]) PET/CT and expression of HIF-1-alpha could predic...

Detailed Description

Approximately 30% of ER-positive breast cancer will unfortunately display primary resistance to hormonal therapy, and some may develop acquired resistance to the therapy after initial treatment. Hypox...

Eligibility Criteria

Inclusion

  • Postmenopausal female
  • With primary invasive ER positive breast cancer pathologically approved by core needle biopsy
  • The target lesion must be measurable and maximum diameter should be over 2cm.
  • Require and accept Endocrine therapy
  • Never treated with endocrine therapy before
  • Patients must have an ECOG performance status of 0 to 2
  • Leucocyte count must be ≥ 3.0\*10\^9/L and platelet count must be ≥ 40\*10\^9/L; AST/SGOT or ALT/AGPT must be \< 2 times the ULN; serum creatinine must be \< 2 times the ULN

Exclusion

  • Patients with brain and liver metastasis
  • Previous history of severe heart dysfunction (above Class III), infection, osteoporosis, bone related event or disease in endocrine system
  • Combination of other anticancer therapy, with the exception of biphosphonate

Key Trial Info

Start Date :

March 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2014

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT01814449

Start Date

March 1 2012

End Date

May 1 2014

Last Update

March 20 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, China, 200032