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Department of Breast Surgery And Department of Nuclear Medicine, Fudan University Shanghai Cancer Center,

60 Years
90 Years
Open (Enrolling)
Breast Cancer, Hypoxia

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Trial Information

Department of Breast Surgery And Department of Nuclear Medicine, Fudan University Shanghai Cancer Center,

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. Hypoxia is a normal phenomenon in solid tumors that arises, in part, from
uncontrolled proliferation and immature blood vessels. Previous studies have demonstrated
hypoxia significantly reduced both the growth-promoting effects of estradiol (E2) and the
growth-inhibitory effects of an antiestrogen on ER-positive breast cancer cell lines. A
recent study comparing neoadjuvant letrozole with letrozole plus metronomic cyclophosphamide
found that increased levels of HIF-1a were significantly associated with resistance to
treatment. Taken together, these data indicate that hypoxia might be associated with
endocrine resistance in breast cancer.

With PET/CT, radiolabeled hypoxia-avid compounds can be applied to evaluate oxygenation
status in experimental or human tumors. 18F-labeled fluoromisonidazole (1-[2-nitro-
1-imidazolyl]-2-hydroxy-3-fluoropropane [18F-FMISO]) PET/CT is the most widely used one in
the clinic. Studies have demonstrated an excellent correlation between the 18F-FMISO uptake
and oxygenation status of several cancers including breast cancer.

The major aim of our study was to analyze uptake of 18FFMISO as well as the IHC expression
of HIF-1-alpha in ER-positive breast cancers, and to predict the clinical, pathological and
biological response of primary endocrine therapy.

Inclusion Criteria:

1. Postmenopausal female

2. With primary invasive ER positive breast cancer pathologically approved by core
needle biopsy

3. The target lesion must be measurable and maximum diameter should be over 2cm.

4. Require and accept Endocrine therapy

5. Never treated with endocrine therapy before

6. Patients must have an ECOG performance status of 0 to 2

7. 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 Criteria:

1. Patients with brain and liver metastasis

2. Previous history of severe heart dysfunction (above Class III), infection,
osteoporosis, bone related event or disease in endocrine system

3. Combination of other anticancer therapy, with the exception of biphosphonate

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Clinical Objective Response

Outcome Description:

Tumor response was evaluated according to the criteria of the World Health Organization. Clinical tumor progression (PD) was defined as an increase of at least 25% in tumor size; stable disease (SD) as an increase of less than 25% or a reduction of less than 50%; partial response (cPR) as a tumor shrinkage greater than 50%; and complete response (cCR) as the complete disappearance of all clinical signs of disease.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Guangyu Liu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital/Institute,Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Hypoxia
  • Breast cancer
  • Hypoxia
  • Hypoxia related gene
  • Endocrine therapy
  • Treatment resistance
  • Breast Neoplasms
  • Anoxia