Study on Sarilumab and Capecitabine for Treating Advanced and High-Risk Breast Cancer

Sponsor: University of Southern California

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04333706

Provider View

This clinical trial is exploring a new treatment combination of Sarilumab and Capecitabine to improve outcomes for patients with advanced or high-risk breast cancer. The study aims to find the best dose and assess the effectiveness of this combination in reducing cancer that remains after initial treatments.

Patient Parameters

Program Overview

This study is testing a new approach to treat triple negative breast cancer (TNBC) that remains after initial treatments. TNBC is a type of breast cancer that is more aggressive and has fewer treatment options. The study aims to improve survival and increase the cure rate by using a combination of Sarilumab and Capecitabine. Patients with advanced TNBC are at high risk of the cancer spreading within two years, especially if the cancer is not completely gone after initial chemotherapy and surgery.

Description

The study has two parts: Phase I and Phase II.

In Phase I, patients with advanced TNBC that is HER2/neu-negative and resistant to hormone therapy will receive Sarilumab and Capecitabine. Sarilumab will be given in increasing doses to find the safest and most effective dose. Blood samples will be collected during treatment, and bone marrow samples are optional.

In Phase II, patients with Stage I to III TNBC who still have some cancer after initial treatment will receive Sarilumab and Capecitabine. This phase will compare the new combination treatment to past treatments with Capecitabine alone. Blood samples will be collected during treatment, and bone marrow samples are optional.

A separate study will run alongside both phases to collect more information on how Capecitabine works in patients with TNBC who have some cancer remaining after initial treatment. Blood samples will be collected, and bone marrow samples are optional.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and be able to follow study procedures.
  • Open to both men and women aged 18 and older.
  • Must have a confirmed diagnosis of metastatic triple negative or hormone-resistant, HER2/neu-negative breast cancer.
  • Must have a life expectancy of at least 6 months (Phase I only).
  • Must have completed any previous chemotherapy at least 3 weeks before starting the study. Prior Capecitabine is allowed if not used immediately before this study (Phase I only).
  • Must have a confirmed diagnosis of TNBC with some cancer remaining after initial treatment (Phase II and Parallel Baseline Arm only).
  • Must not have received prior systemic treatment for breast cancer, except for initial treatment, which must not have included Capecitabine or Sarilumab (Phase II and Parallel Baseline Arm only).
  • Must have a performance status score of 2 or less, indicating good overall health.
  • Must have adequate organ function based on specific blood tests.
  • Women of childbearing potential must use effective contraception during the study and for 24 weeks after the last dose.
  • Men with partners of childbearing potential must agree to use contraception during the study and for 24 weeks after the last dose.

Exclusion Criteria

  • Women or men of childbearing potential who are not willing to use contraception during the study and for 24 weeks after the last dose.
  • Women who are pregnant or breastfeeding.
  • Any other medical condition that could interfere with the study or increase the risk of complications.
  • Hepatitis B infection, except for those vaccinated (Phase I and II only).
  • History of tuberculosis or diverticulitis (Phase I and II only).
  • Use of live vaccines within 30 days before starting the study (Phase I and II only).
  • History of another cancer with a higher risk of recurrence or death than the study-related cancer.
  • Prisoners or those involuntarily incarcerated.
  • Individuals detained for psychiatric or physical illness.
  • Inability to comply with study procedures.

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