Clinical trial · Observational
Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer
Department of Breast Surgery And Department of Nuclear Medicine, Fudan University Shanghai Cancer Center,
NCT01814449CI-TRIAL-00009770unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 predict response of primary endocrine therapy in ER-positive breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hypoxia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18FMISO PET/CT scan | Other | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Hypoxic Group
- description
- Higher 18FMISO uptake (Target to background Ratio, TBR\>1.2) in Primary breast cancer by 18FMISO PET/CT scan.Primary endocrine therapy Letrozole was given to the patients.
- interventionNames
- Other: 18FMISO PET/CT scan
- Drug: Letrozole
- label
- Non-Hypoxic Group
- description
- Lower 18FMISO uptake (TBR\<1.2)in primary breast cancer by 18FMISO PET/CT scan.Primary endocrine therapy letrozole was given to the patients.
- interventionNames
- Other: 18FMISO PET/CT scan
- Drug: Letrozole
Primary outcomes (1)
- measure
- Clinical Objective Response
- timeFrame
- 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.