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CDK 4/6 Inhibitor

Immunotherapy Combinations for Breast Cancer (MORPHEUS HR+BC Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death from any cause (up to 6 years overall)

Awards & highlights

MORPHEUS HR+BC Trial Summary

This trial is testing different combinations of immunotherapy drugs to see which are the most effective at treating HR-positive, HER2-negative breast cancer that has progressed after treatment with a CDK4/6 inhibitor.

Who is the study for?

This trial is for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer that worsened after CDK4/6 inhibitor therapy. Participants should have measurable disease, a life expectancy over 3 months, and good organ function. They must not have severe recent illnesses, uncontrolled diseases, certain past cancers within 2 years (except low-risk types), or previous adverse reactions to the study drugs.Check my eligibility

What is being tested?

The trial tests combinations of immunotherapies and hormone therapies like Fulvestrant and Exemestane with targeted treatments such as Ipatasertib in women whose breast cancer has progressed on CDK4/6 inhibitors. It's split into two stages: initial randomization to control or combination treatment; then possible new triplet combos if needed due to progression or side effects.See study design

What are the potential side effects?

Potential side effects include immune-related inflammation in various organs, infusion reactions from antibody treatments like Atezolizumab, hormonal changes from drugs like Tamoxifen and Fulvestrant, liver issues from Ipatasertib, bleeding risks associated with Bevacizumab use, and general symptoms such as fatigue.

MORPHEUS HR+BC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My breast cancer is advanced, cannot be removed by surgery, is HR-positive and HER2-negative.

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I am postmenopausal according to the study's criteria.

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I am advised to undergo hormone therapy, and chemotherapy is not recommended for me now.

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My breast cancer has returned or worsened after the latest treatment.

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My condition worsened despite hormonal therapy for advanced cancer.

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I am able to care for myself and perform daily activities.

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My cancer progressed despite hormone therapy and CDK4/6 inhibitor treatment.

MORPHEUS HR+BC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death from any cause (up to 6 years overall)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death from any cause (up to 6 years overall)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause (up to 6 years overall) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Objective Response during Stage 1 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

Secondary outcome measures

Abemaciclib Plasma Concentration during Stage 1

Atezolizumab Serum Concentration during Stage 1

Atezolizumab Serum Concentration during Stage 2

+17 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

MORPHEUS HR+BC Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Stage 2: Atezolizumab + Bevacizumab + Endocrine TherapyExperimental Treatment5 Interventions

Those who progress or experience unacceptable toxicity during treatment in Stage 1 may be eligible to enter Stage 2. Participants will receive triplet combination therapy with atezolizumab plus bevacizumab plus one of three endocrine therapies (fulvestrant, exemestane, or tamoxifen) selected by the physician. Treatment in Stage 2 will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group II: Stage 1: Mandatory On-Treatment BiopsyExperimental Treatment5 Interventions

For experimental combination arms that demonstrate clinical activity during the preliminary phase, the Sponsor may open enrollment into a separate mandatory on-treatment biopsy cohort for that combination.

Group III: Stage 1: Atezolizumab + Ipatasertib + FulvestrantExperimental Treatment3 Interventions

Participants will receive triplet combination treatment with atezolizumab plus ipatasertib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.

Group IV: Stage 1: Atezolizumab + IpatasertibExperimental Treatment2 Interventions

Participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.

Group V: Stage 1: Atezolizumab + FulvestrantExperimental Treatment2 Interventions

Participants will receive doublet combination treatment with atezolizumab plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group VI: Stage 1: Atezolizumab + EntinostatExperimental Treatment2 Interventions

Participants will receive doublet combination treatment with atezolizumab plus entinostat until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group VII: Stage 1: Atezolizumab + Abemaciclib + FulvestrantExperimental Treatment3 Interventions

Participants will receive triplet combination treatment with atezolizumab plus abemaciclib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group VIII: Stage 1: FulvestrantActive Control1 Intervention

Participants will receive fulvestrant until unacceptable toxicity or disease progression according to RECIST v1.1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Exemestane

2003

Completed Phase 4

~7880

Ipatasertib

2011

Completed Phase 3

~2320

Entinostat

2017

Completed Phase 2

~1170

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody

2015

Completed Phase 2

~480

Bevacizumab

2013

Completed Phase 4

~5280

Tamoxifen

2005

Completed Phase 4

~29860

Abemaciclib

2019

Completed Phase 2

~1710

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,916 Total Patients Enrolled

160 Trials studying Breast Cancer

91,467 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,364 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK 4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03280563 — Phase 1 & 2

Breast Cancer Research Study Groups: Stage 1: Atezolizumab + Entinostat, Stage 2: Atezolizumab + Bevacizumab + Endocrine Therapy, Stage 1: Atezolizumab + Ipatasertib + Fulvestrant, Stage 1: Atezolizumab + Ipatasertib, Stage 1: Atezolizumab + Fulvestrant, Stage 1: Atezolizumab + Abemaciclib + Fulvestrant, Stage 1: Fulvestrant, Stage 1: Mandatory On-Treatment Biopsy

Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03280563 — Phase 1 & 2

Abemaciclib (CDK 4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03280563 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial happening in more than one country?

"Presently, there are 12 sites enrolling patients for this study. To name a few, these locations include Pittsburgh, Torrance and San Francisco. If you choose to enroll in the study, it may be helpful to select the site nearest to your location in order minimize travel demands."

Answered by AI

Can you please tell me if Abemaciclib has been used in research previously?

"The first recorded clinical trial for abemaciclib was in 1994 at Queen Mary University of London. As of now, a total of 1413 completed trials have been conducted. 955 studies are still active, with many taking place in Pittsburgh and California."

Answered by AI

How many people are included in this clinical trial?

"This particular research project is not taking any more volunteers at the moment. The listing was made on December 26th, 2017 and updated September 28th, 2022. There are 2373 trials searching for breast cancer patients and 955 trials searching for Abemaciclib patients that are still open."

Answered by AI

For what sorts of ailments is Abemaciclib usually prescribed?

"Abemaciclib is most commonly given to patients with estrogen receptors, but it can also be used as a treatment for other conditions like malignant neoplasms and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Is it possible to sign up for this experiment right now?

"As of now, this study is not looking for any more participants. It was first posted on December 26th, 2017 and was last updated on September 28th, 2022. However, there are 2373 other trials actively recruiting breast cancer patients and 955 studies involving Abemaciclib that are currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03280563.

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