Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer

February 26, 2023 updated by: Yosra farghaly sayed mahmoud, Assiut University

Aromatase Inhibitors Plus Metronomic Capecitabine in Treatment of Patients With Recurrent or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

The study is designed to assess the treatment outcomes following treatment with letrozole plus metronomic capecitabine in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their recurrent /metastatic disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is recognized as the commonest cancer in females, and the second commonest malignant tumor, after lung cancer, in overall figures worldwide.

In 2021, an estimated 281,550 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 49,290 new cases of non-invasive (in situ) breast cancer.

About 43,600 women in the U.S. are expected to die in 2021 from breast cancer. Death rates have been steady in women under 50 since 2007, but have continued to drop in women over 50. The overall death rate from breast cancer decreased by 1% per year from 2013 to 2018. These decreases are thought to be the result of treatment advances and earlier detection through screening.

According to the World Health Organization, breast cancer became the most common cancer globally as of 2021, accounting for 12% of all new annual cancer cases worldwide.

Breast cancer is increasingly recognized as a heterogeneous disease exhibiting substantial differences concerning biological behavior and requiring distinct therapeutic interventions. There has been a continuous decline in mortality over recent years due to improvements in early diagnosis and the increased availability of more effective treatments. However, despite these improvements, The treatment of hormone receptor-positive metastatic breast cancer (MBC) who developed disease progression on first-line hormonal treatment that included aromatase inhibitors (AI) represents a challenge as those patients ultimately develop resistant disease unresponsive to standard lines of estrogen receptors (ER) blockade. Capecitabine is an oral chemotherapy that mimics continuous infusion of 5-FU with known activity in MBC. It might be preferred because of its tolerability and relatively lower toxicity than other chemotherapeutic agents. Metronomic chemotherapy is defined as the frequent (daily, many times a week, or weekly) or continuous administration of low dose chemotherapeutic agents, without prolonged drug-free intervals. This way of administration improves the antiangiogenic activity of chemotherapy. Another important advantage of this approach is the significant reduction in toxicity. Capecitabine's pharmacokinetics and high safety profile make it a suitable drug for metronomic administration. Many studies reported that the overall response rate can be improved by (15.8-21.7%) when metronomic chemotherapy is combined with aromatase inhibitors. This combination can also decrease the level of both the Ki-67 index and VEGF-A significantly in the tumor tissue. It was reported that the patients who received letrozole plus metronomic chemotherapy achieved a higher overall response rate (ORR) than those who received letrozole alone (87.7% vs 71.9% respectively.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients > 18 years old with loco regionally recurrent or metastatic disease not amenable to curative therapy
  • Confirmed diagnosis of hormonal receptor positive (HR+)/Her2-negative breast cancer
  • If the patient is pre-/peri- menopausal, a luteinizing hormone releasing hormone (LHRH) agonist will be given for at least 28 days before randomization or ovarian ablation or suppression by surgery or radiotherapy
  • Measurable disease defined by RECIST version 1.1,
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Adequate organ and marrow function

Exclusion Criteria:

  • Patients with advanced, symptomatic visceral spread (visceral crisis)
  • Patients diagnosed with central nervous system metastases
  • Second primary malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor response
Time Frame: 1 year
tumor response in form of change tumor size
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 1 year
decrease sites of metastasis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2023

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

June 6, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 26, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIs with chemotherapy in MBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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