Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer

NCT01814449 | Unknown DMC

• 1 other identifier: 20120224.1.1
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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 predict response of primary endocrine therapy in ER-positive breast cancer

Conditions

Breast Cancer; Hypoxia

Keywords

Breast cancer; Hypoxia; Hypoxia related gene; Endocrine therapy; Treatment resistance

Outcome Measures

Primary Outcomes (1)

• Clinical Objective Response

  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.

  4 months

Secondary Outcomes (2)

• Pathological Response

  4 months

• Depression of Ki67 score

  3 months

Other Outcomes (1)

• Disease free survival

  5 years

Study Arms (2)

Hypoxic Group

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.

Other: 18FMISO PET/CT scan; Drug: Letrozole

Non-Hypoxic Group

Lower 18FMISO uptake (TBR\<1.2)in primary breast cancer by 18FMISO PET/CT scan.Primary endocrine therapy letrozole was given to the patients.

Other: 18FMISO PET/CT scan; Drug: Letrozole

Interventions

18FMISO PET/CT scan OTHER

The baseline 18F-FMISO PET/CT scans were scheduled before initiation of endocrine therapy. All patients were injected intravenously with 370 MBq of 18F-FMISO and PET/CT static emission scans were conducted at 4 hours after injection.

Hypoxic Group; Non-Hypoxic Group

Letrozole DRUG

Patients were assigned to primary endocrine therapy with letrozole 2.5mg daily for at least 4 months.

Hypoxic Group; Non-Hypoxic Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women who had ER-a-positive breast cancer at stages II-IV and had never received prior endocrine therapy were considered eligible for this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Each patient underwent diagnostic core-needle biopsy on the primary site at baseline. A therapeutic surgery or a second core-needle biopsy on the primary site was planned in a subset of patients after at least 3 months of primary letrozole therapy. Both biopsy and surgical samples of primary tumors were routinely embedded in paraffin wax and cut to 3- to 5-mm thickness and dried overnight for immunohistochemistry testing.Immunohistochemistry staining for HIF-1-alpha and Ki67 were performed on 3- to 5-mm serial sections on coated slides.

MeSH Terms

Conditions

Breast Neoplasms; Hypoxia

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Guangyu Liu, M.D.

  Cancer Hospital/Institute,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangyu Liu, M.D.

CONTACT

86-21-64175590; liugy123@yahoo.com

Jingyi Cheng, M.D.

CONTACT

86-21-64175590; ququmail@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Department of Breast Surgery,Cancer Hopital & Institute

Study Record Dates

• First Submitted: March 16, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

CN (1)