Study on Atezolizumab, Cobimetinib, and Eribulin for Treating Chemotherapy-Resistant Metastatic Inflammatory Breast Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03202316

Provider View

This clinical trial is testing a combination of three drugs—atezolizumab, cobimetinib, and eribulin—to see if they can effectively treat inflammatory breast cancer that has spread and is resistant to chemotherapy. The study aims to find out if this combination can help the immune system fight cancer and stop tumor growth.

Patient Parameters

Program Overview

This study is exploring a new treatment for inflammatory breast cancer that has spread to other parts of the body and is resistant to chemotherapy. The treatment combines three drugs: atezolizumab, an immunotherapy that helps the immune system attack cancer cells; cobimetinib, which blocks enzymes needed for cancer cell growth; and eribulin, a chemotherapy drug that stops cancer cells from growing and spreading. Researchers want to see if this combination is more effective than current treatments.

Description

The main goal of this study is to determine how well the combination of atezolizumab, cobimetinib, and eribulin works in treating patients with metastatic inflammatory breast cancer. The study is divided into two groups:

  • Cohort I: Patients receive atezolizumab through an IV every two weeks, cobimetinib as a daily pill for three weeks with a one-week break, and eribulin through an IV on specific days of the treatment cycle. This cycle repeats every 21 days for the first four cycles, then every 28 days.
  • Cohort II: Patients receive atezolizumab through an IV every three weeks for the first six cycles, then every four weeks, and eribulin through an IV on specific days of the treatment cycle. This cycle repeats every 21 days for the first six cycles, then every 28 days.

The study will also look at the safety and side effects of these treatments, how long patients respond to the treatment, and overall survival rates. Researchers will also study changes in cancer-related markers in the blood and tissue samples to understand how the treatment affects the cancer environment.

After completing the treatment, patients will be monitored for three months and then every six months for two years to track their progress and health.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of inflammatory breast cancer.
  • Cancer must have spread or returned after standard treatments.
  • Must have at least one tumor that can be measured and one that can be biopsied.
  • Must have good overall health with a performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for at least five months after the last treatment.
  • Must not have any severe or uncontrolled medical conditions.

Exclusion Criteria

  • Cannot have received any other cancer treatment within two weeks before starting the study treatment.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have significant liver disease or active infections.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot have active autoimmune diseases or immune deficiencies, with some exceptions for well-controlled conditions.
  • Cannot have a history of lung diseases like pneumonitis.
  • Cannot have other serious medical conditions that could interfere with the study.
  • Cannot have received certain other treatments or medications within a specified time before the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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