NCT02344550

Brief Summary

The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

4.8 years

First QC Date

May 7, 2014

Last Update Submit

July 29, 2020

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancerHER2 negativehormone-receptor positive

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    At time disease progression

    Participants will be followed every 8 weeks , up to 12 Months

Secondary Outcomes (1)

  • Overall Response rate

    Participants will be followed every 8 weeks, up to 12 Months

Other Outcomes (3)

  • Clinical benefit rate (CBR)

    Participants will be followed every 8 weeks, up to 12 Months

  • Overall survival

    Participants will be followed every 8 weeks, up to 12 Months

  • Number of patients with adverse events

    Participants will be followed every 8 weeks, up to 12 Months

Study Arms (2)

Everolimus arm

EXPERIMENTAL

Everolimus 10mg p.o. daily Letrozole 2.5 mg p.o. daily Leuprorelin (Leuprolide) 3.75mg SC every 4 weeks

Drug: Everolimus(afinitor)Drug: LetrozoleDrug: Leuprolide(Lorelin Depot)

Control arm

ACTIVE COMPARATOR

Letrozole 2.5 mg p.o. daily Leuprorelin (Leuprolide) 3.75mg SC every 4 weeks

Drug: LetrozoleDrug: Leuprolide(Lorelin Depot)

Interventions

Everolimus(afinitor)DRUG

Everolimus 10mg p.o. daily

Also known as: Afinitor
Everolimus arm
LetrozoleDRUG

Letrozole 2.5 mg p.o. daily

Also known as: Femara
Control armEverolimus arm
Leuprolide(Lorelin Depot)DRUG

Leuprorelin (Lorelin Depot)3.75 mg SC in every 4 weeks

Also known as: Leuprorelin (Dongkook Pharm Co Ltd)
Control armEverolimus arm

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20 years
  • Histologically or cytologically confirmed, HER-2 negative breast cancer with recurrent or metastatic disease
  • No HER2 overexpressing breast cancer
  • Premenopausal status, defined as either
  • ER and/or PR positive
  • Progressive disease on tamoxifen treatment or sequential or combined treatment of tamoxifen and GnRH agonist as a palliative or an adjuvant endocrine treatment
  • Duration of tamoxifen treatment should be at least 3 months or more
  • No prior treatment with an aromatase inhibitor or inactivator or fulvestrant, or mTOR inhibitors
  • One line of chemotherapy in metastatic setting is permitted
  • ECOG performance status 0,1 or 2
  • At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease
  • Adequate hematologic, liver and kidney function

You may not qualify if:

  • Pregnant women or patients in lactation
  • More than one line of prior chemotherapy for metastatic breast cancer
  • GnRH agonist with tamoxifen treatment within 2 weeks.
  • Active malignancy other than breast cancer, in situ carcinoma of the cervix, controlled resected thyroid well differentiated carcinoma or non-melanomatous skin cancer in the past 5 years
  • Active cardiovascular disease such as angina, ventricular tachycardia, uncontrolled hypertension
  • Active uncontrolled infection
  • Symptomatic brain metastases
  • Lymphangitic carcinomatosis involving \>50% of the lungs
  • Evidence of metastases involving more than one third of the liver on sonogram or CT
  • Patients not able or unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

EverolimusLetrozoleLeuprolide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Sung-Bae Kim, M.D., Ph D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph D.

Study Record Dates

First Submitted

May 7, 2014

First Posted

January 26, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

KR(1)