NCT00908531

Brief Summary

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
123

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2009

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
terminated

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

May 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

4.6 years

First QC Date

May 26, 2009

Last Update Submit

April 25, 2019

Conditions

Operable Breast Neoplasms

Keywords

Breast neoplasmsRandomised trialAromatase InhibitorsPreoperative careAge 60 or olderHormone receptor positive tumorTumor lager than 2 cmNo distant metastasis

Outcome Measures

Primary Outcomes (2)

  • pCR

    Complete response rate

    At four months

  • Clinical tumor response

    Ultrasound

    At four months

Secondary Outcomes (1)

  • Overall survival

    At ten years

Study Arms (2)

Postoperative letrozole

ACTIVE COMPARATOR

Definitive surgery without preoperative AI treatment

Drug: letrozole (Femara)

Preoperative letrozole

EXPERIMENTAL

Treatment with letrozole for 4 months before definitive surgery.

Drug: letrozole (Femara)

Interventions

letrozole (Femara)DRUG

tablet 2.5 mg daily

Also known as: Femara
Postoperative letrozolePreoperative letrozole

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Age 60 years or older
  • Measurable non-metastatic and non-inflammatory breast cancer
  • Tumor of 2 cm or larger
  • ER and/or PgR positive tumor
  • Co-morbidity index 0 - 3, e.g., no other serious medical condition

You may not qualify if:

  • Prior medical therapy for a malignant disease, including aromatase inhibitors
  • Distant metastasis
  • Need for chemotherapy
  • Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
  • Treatment with a non-approved drug within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dept. of Breast Surgery; Aalborg Sygehus

Aalborg, DK-9000, Denmark

Location

Dept. of Surgery; Århus Sygehus

Aarhus, DK-8000, Denmark

Location

Dept. of Breast Surgery; Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Dept. of Surgery; Sydvestjysk Sygehus Esbjerg

Esbjerg, DK-6700, Denmark

Location

Dept. of Breast Surgery; Herlev Hospital

Herlev, DK-2730, Denmark

Location

Dept. of Oncology; Odense University Hospital

Odense, DK-5000, Denmark

Location

Depart. of Breast Surgery, Ringsted Sygehus

Ringsted, 4100, Denmark

Location

Dept. of Breast Surgery; Vejle Sygehus

Vejle, DK-7100, Denmark

Location

Dept. of Breast Surgery; Regionshospitalet Viborg

Viborg, DK-8800, Denmark

Location

Related Publications (2)

  • Skriver SK, Laenkholm AV, Rasmussen BB, Handler J, Grundtmann B, Tvedskov TF, Christiansen P, Knoop AS, Jensen MB, Ejlertsen B. Neoadjuvant letrozole for postmenopausal estrogen receptor-positive, HER2-negative breast cancer patients, a study from the Danish Breast Cancer Cooperative Group (DBCG). Acta Oncol. 2018 Jan;57(1):31-37. doi: 10.1080/0284186X.2017.1401228. Epub 2017 Nov 23.

    PMID: 29168427BACKGROUND

  • Skriver SK, Jensen MB, Knoop AS, Ejlertsen B, Laenkholm AV. Tumour-infiltrating lymphocytes and response to neoadjuvant letrozole in patients with early oestrogen receptor-positive breast cancer: analysis from a nationwide phase II DBCG trial. Breast Cancer Res. 2020 May 14;22(1):46. doi: 10.1186/s13058-020-01285-8.

    PMID: 32410705DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bent Ejlertsen, MD, PhD

    DBCG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

DK(9)