NCT04571437

Brief Summary

A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

September 25, 2020

Last Update Submit

September 25, 2020

Conditions

Breast CancerEstrogen Receptor-positive Breast CancerMetastatic Breast Cancer

Keywords

Advanced breast cancerchemo-hormonalhormone positivemetronomic capecitabine

Outcome Measures

Primary Outcomes (1)

  • 6 months Progression free survival rate

    Percentage of patients alive and progression-free at 6 months

    6 months from the start of treatment

Secondary Outcomes (8)

  • Overall response rate

    6 months from the start of treatment

  • Adverse events rates in both groups

    6 months from the start of treatment

  • Quality of life assessment using FACIT-B questionnare

    6 months

  • Median progression free survival

    18 months

  • Time to treatment failure

    18 months

  • +3 more secondary outcomes

Study Arms (2)

Chemo endocrine treatment (A)

ACTIVE COMPARATOR

Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously

Drug: CapecitabineDrug: Letrozole 2.5mg

Endocrine treatment only (B)

ACTIVE COMPARATOR

Letrozole 2.5mg PO daily

Drug: Letrozole 2.5mg

Interventions

CapecitabineDRUG

Capecitabine metronomic combined with Letrozole

Also known as: Xeloda
Chemo endocrine treatment (A)
Letrozole 2.5mgDRUG

Letrozole daily alone

Also known as: Femara
Chemo endocrine treatment (A)Endocrine treatment only (B)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female sex
  • Age 18-70
  • ECOG-PS 0-II.
  • Histopathological proof of breast cancer
  • ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
  • Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
  • Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
  • Adequate organ function.
  • Signed informed consent

You may not qualify if:

  • Inadequate organ functions.
  • Disease progression while on prior aromatase inhibitor therapy.
  • Primary endocrine resistance.
  • Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
  • Refusal to sign consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Azim HA, Saleh MA, Essam Eldin P, Abdelhafeez AAM, Hassan M, Kassem L. Combination of metronomic capecitabine and letrozole in metastatic hormone receptor positive, HER2 negative breast cancer: a randomized phase II trial. J Chemother. 2025 Apr;37(2):159-167. doi: 10.1080/1120009X.2024.2342741. Epub 2024 May 20.

    PMID: 38764430DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CapecitabineLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesNitrilesOrganic ChemicalsTriazolesAzoles

Study Officials

  • Mariam Saleh, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Saleh, M.D

CONTACT

+201003677227mariamsaleh309@gmail.com

Loay Kassem, M.D

CONTACT

+201003022907loay.kassem@cairocure.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

March 1, 2020

Primary Completion

October 31, 2021

Study Completion

April 30, 2022

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)