Study on Avelumab with Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin for Treating Advanced or Recurrent Triple Negative Breast Cancer

Sponsor: Hope Rugo, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03971409

Provider View

This clinical trial is exploring how well different combinations of treatments work for patients with advanced or recurrent triple negative breast cancer that cannot be removed by surgery. The study involves using avelumab, an immunotherapy drug, with other medications to see if they can help control the cancer.

Patient Parameters

Program Overview

This study is testing different combinations of treatments for patients with stage IV or recurrent triple negative breast cancer that cannot be surgically removed. The treatments include avelumab, an immunotherapy drug that helps the immune system fight cancer, combined with either liposomal doxorubicin, binimetinib, or sacituzumab govitecan. The goal is to see if these combinations can better control the cancer. The study includes a two-week period where medications are given to stimulate the immune system, hoping to improve the response to avelumab.

Description

In this study, patients are randomly assigned to one of three treatment groups:

  • Group A: Patients take binimetinib pills twice a day for 15 days to start. Then, they continue taking binimetinib daily, receive avelumab through an IV on days 1 and 15, and get liposomal doxorubicin through an IV on day 1. This cycle repeats every 28 days if the cancer does not worsen and side effects are manageable.

  • Group B: Patients receive sacituzumab govitecan through an IV on days -15 and -8 to start. Then, they continue receiving sacituzumab govitecan on days 1 and 8, and avelumab through an IV on days 1 and 15. This cycle repeats every 28 days if the cancer does not worsen and side effects are manageable.

  • Group C: Patients receive liposomal doxorubicin through an IV on day -15 to start. Then, they continue receiving liposomal doxorubicin on day 15 and every 4 weeks, along with avelumab through an IV on days 1 and 15. This cycle repeats every 28 days if the cancer does not worsen and side effects are manageable.

After finishing the study treatment, patients will have follow-up visits 30 days later, then every 6 months for at least a year. The study aims to evaluate the effectiveness of avelumab combined with different drugs, monitor safety and side effects, and assess patient-reported outcomes.

Eligibility Criteria

Inclusion Criteria

  • Signed and dated written informed consent
  • Age 18 or older
  • Good overall health with an ECOG performance status of 0 or 1
  • Have stage IV or unresectable recurrent triple negative breast cancer
    • Cancer must be estrogen/progesterone receptor-negative and HER2-negative
    • Must have measurable disease that can be tracked by scans or other methods
    • Must be able to have a biopsy at the start of the study
    • Known PD-L1 status of the tumor/immune cells
  • Adequate organ function, including:
    • Normal heart function
    • Sufficient blood cell counts
    • Normal liver and kidney function
  • Agree to use effective contraception during the study and for 30 days after the last dose
  • Patients who cannot read/write in English can participate but will not complete certain questionnaires
  • Patients who previously failed screening can re-enroll if they meet criteria and have not received new cancer treatment since initial screening

Exclusion Criteria

  • More than 2 lines of chemotherapy for metastatic cancer
  • More than 1 prior line of checkpoint inhibitor therapy for metastatic cancer
  • Previous treatment with sacituzumab govitecan
  • Currently receiving other cancer treatments
  • Recent major surgery or radiation
  • Use of certain medications like corticosteroids or immunosuppressants
  • Other cancers within the last 5 years, except for certain skin or cervical cancers
  • Untreated or unstable brain metastases
  • History of organ transplantation
  • Significant infections or autoimmune diseases
  • Lung disease that may interfere with treatment
  • Uncontrolled asthma or heart conditions
  • History of pancreatitis or eye conditions like retinal vein occlusion
  • Need for certain blood thinners
  • Severe allergies to study drugs
  • Recent vaccinations
  • Pregnant or breastfeeding women
  • Current alcohol or drug abuse
  • Incarcerated individuals or those unable to consent or comply with study requirements

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