A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:September 30, 2017
End Date:October 5, 2022
Contact:Reference Study ID Number: CO39611 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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)

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several
immunotherapy-based combination treatments in participants with locally advanced or
metastatic HR-positive, HER2-negative breast cancer who have progressed during or following
treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line
setting, 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.


Inclusion Criteria for Both Stages:

- Measureable disease per RECIST v1.1

- Adequate hematologic and end organ function

- Disease progression during or after first- or second-line hormonal therapy with CDK4/6
inhibitor

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 first- or second-line hormonal therapy for locally
advanced or metastatic disease

- Postmenopausal according to protocol-defined criteria

- Life expectancy >3 months

- 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

Exclusion Criteria 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 test

- Active hepatitis B or C

- Active tuberculosis

- 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

- For patients entering Stage 2, recovery from all immunotherapy-related adverse events
to Grade 1 or better or to baseline at the time of consent

Exclusion Criteria for Stage 1:

- 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

- Eligibility only for the control arm

- Prior treatment with inhibitors as specified in the protocol

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

- Grade 2 or higher proteinuria
We found this trial at
19
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Charlotte, North Carolina 28211
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Columbus, OH
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6560 Fannin Street
Houston, Texas 77030
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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300 Halket Street
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97213
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1 Emek HaEla Street
Ramat Gan,
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1600 Divisadero Street
San Francisco, California 94115
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1624 South I Street
Tacoma, Washington 98405
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5520 Park Avenue
Trumbull, Connecticut 06611
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West Hills, California 91307
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West Hills, CA
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