Skip to main content

Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with metastatic HR-positive, HER2-negative breast cancer who have progressed during or following first-line metastatic treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.

Official Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer)

Keywords

Breast Neoplasms Bevacizumab Atezolizumab Fulvestrant Exemestane Tamoxifen Antibodies Antibodies, Monoclonal Hormones Estradiol

Eligibility

You can join if…

Open to females ages 18 years and up

for Both Stages:

  • Measureable disease per RECIST v1.1 with tumor accessible for biopsy
  • Adequate hematologic and end organ function

Inclusion Criteria for Stage 1:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer
  • Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry
  • Recurrence or progression following most recent systemic breast cancer therapy
  • Disease progression during or after CDK4/6 inhibitor treatment for metastatic disease
  • Postmenopausal according to protocol-defined criteria
  • Life expectancy >3 years
  • Available tumor specimen for determination of PD-L1 status

Inclusion Criteria for Stage 2:

  • ECOG performance status of 0-2
  • Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen

You CAN'T join if...

for Both Stages:

  • Significant or uncontrolled comorbid disease as specified in the protocol
  • Uncontrolled tumor-related pain
  • Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions
  • Positive human immunodeficiency virus or hepatitis B or C
  • Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death
  • History of or known hypersensitivity to study drug or excipients

Exclusion Criteria for Stage 1:

  • HER2-positive breast cancer
  • Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol
  • Unresolved AEs from prior anti-cancer therapy

Exclusion Criteria for Stage 2:

  • Unacceptable toxicity with atezolizumab during Stage 1
  • Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol
  • Significant abdominal or intestinal manifestations within 6 months prior to treatment
  • Proteinuria

Locations

  • UCSF Helen Diller Family CCC not yet accepting patients
    San Francisco, California, 94115, United States
  • Providence Cancer Center not yet accepting patients
    Portland, Oregon, 97231, United States
  • Northwest Medical Specialties, PLLC; Research Department not yet accepting patients
    Tacoma, Washington, 98405, United States
  • Sarah Cannon Research Institute accepting new patients
    Nashville, Tennessee, 37203, United States
  • University of Alabama at Birmingham not yet accepting patients
    Birmingham, Alabama, 35249, United States
  • University of Michigan withdrawn
    Ann Arbor, Michigan, 48109-0934, United States
  • Northwest Georgia Oncology Centers PC - Marietta not yet accepting patients
    Marietta, Georgia, 30060, United States
  • University of Pittsburgh Medical Center Health System; Dept. of Newborn Medicine not yet accepting patients
    Pittsburgh, Pennsylvania, 15213, United States
  • Levine Cancer Institute not yet accepting patients
    Charlotte, North Carolina, 28204, United States
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center not yet accepting patients
    Baltimore, Maryland, 21231, United States
  • Memorial Sloan Kettering Cancer Center not yet accepting patients
    New York, New York, 10065, United States
  • Yale University School Of Medicine; Yale Cancer Center not yet accepting patients
    Trumbull, Connecticut, 06611, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03280563
Phase
Phase 1/2
Study Type
Interventional
Last Updated
October 24, 2017
I’m interested in this study!