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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04942899
Collaborator
(none)
70
45

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Phase II Trial of Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Hormone Receptor _ Positive ,HER2 _ Negative Breast Cancer
Anticipated Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
May 31, 2025

Outcome Measures

Primary Outcome Measures

  1. tumor response [1 year]

    tumor response in form of change tumor size

Secondary Outcome Measures

  1. progression free survival [1 year]

    decrease sites of metastasis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Confirmed diagnosis of hormonal receptor-positive (HR+)/Her2-negative breast cancer

  • No prior systemic anti-cancer therapy for advanced HR+ disease except tamoxifen treatment in adjuvant sitting

  • 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) 0-1

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yosra farghaly sayed mahmoud, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04942899
Other Study ID Numbers:
  • AIs with chemotherapy in MBC
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Yosra farghaly sayed mahmoud, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021