NCT00738777

Brief Summary

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
250

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

4 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

13.9 years

First QC Date

August 19, 2008

Last Update Submit

January 20, 2021

Conditions

Breast Cancer

Keywords

pre-operativeendocrine treatmentdrug resistance

Outcome Measures

Primary Outcomes (1)

  • Decrease in tumor cell proliferation and induced apoptosis.

    At baseline and after 2-6 weeks of endocrine treatment

Secondary Outcomes (1)

  • Comparison of changes in gene expression after different endocrine treatment exposures

    At baseline and after endocrine treatment

Study Arms (4)

1

ACTIVE COMPARATOR

Anastrozole

Drug: Anastrozole

2

EXPERIMENTAL

Anastrozole + Fulvestrant

Drug: Anastrozole+Fulvestrant

3

ACTIVE COMPARATOR

Tamoxifen

Drug: Tamoxifen

4

OTHER

Tamoxifen (pre-menopausal and male patients)

Drug: Tamoxifen

Interventions

AnastrozoleDRUG

1 mg,QD,PO

1
Anastrozole+FulvestrantDRUG

Anastrozole; 1 mg, QD, PO Fulvestrant; 500 mg, IM, day 1, 15, 29 and monthly thereafter

2
TamoxifenDRUG

loading dose of 40 mg, TID, PO, during 7 days, Thereafter 20 mg, QD, PO

3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with proven invasive adenocarcinoma of the breast
  • Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer)
  • WHO-performance score 0 or 1
  • Written informed consent

You may not qualify if:

  • Clues of metastatic disease by clinical examination according to most recent NABON guidelines
  • Multicentric breast cancer
  • Inflammatory breast cancer
  • Hormone replacement during the last 12 months
  • Other systemic treatment during the waiting time till surgery
  • Already planned date for surgery within the next 2 weeks
  • Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
  • Patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment
  • NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medisch Centrum Haaglanden

The Hague, South Holland, Netherlands

Location

NKI-AVL

Amsterdam, 1066 CX, Netherlands

Location

St. Antonius ziekenhuis

Nieuwegein, Netherlands

Location

UMC St. Radboud

Nijmegen, Netherlands

Location

Related Publications (1)

  • Reinema FV, Sweep FCGJ, Adema GJ, Peeters WJM, Martens JWM, Bussink J, Span PN. Tamoxifen induces radioresistance through NRF2-mediated metabolic reprogramming in breast cancer. Cancer Metab. 2023 Feb 8;11(1):3. doi: 10.1186/s40170-023-00304-4.

    PMID: 36755288DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AnastrozoleTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Sabine C Linn, MD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2022

Study Completion

June 1, 2024

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

NL(4)