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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
Must not have
Prior allogeneic stem cell or solid organ transplantation
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.
Select...
My breast cancer is advanced, cannot be removed by surgery, is HR-positive and HER2-negative.
Select...
I am postmenopausal according to the study's criteria.
Select...
I am advised to undergo hormone therapy, and chemotherapy is not recommended for me now.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a previous transplant of stem cells or an organ.
Select...
I have recovered from side effects of immunotherapy to my normal health or almost.
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I have received specific treatments for metastatic breast cancer as outlined in the protocol.
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I still have side effects from previous cancer treatments.
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I do not have uncontrolled heart disease or blood clotting disorders.
Select...
I had severe side effects from atezolizumab in Stage 1.
Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I have active tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3890
Exemestane
2003
Completed Phase 4
~7510
Ipatasertib
2017
Completed Phase 3
~3490
Entinostat
2017
Completed Phase 2
~1210
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
2015
Completed Phase 2
~480
Bevacizumab
2013
Completed Phase 4
~5540
Tamoxifen
2005
Completed Phase 4
~30110
Abemaciclib
2019
Completed Phase 2
~1990

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,095,346 Total Patients Enrolled
159 Trials studying Breast Cancer
90,650 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,253 Total Patients Enrolled
137 Trials studying Breast Cancer
71,304 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 2: Atezolizumab + Bevacizumab + Endocrine Therapy, Stage 1: Atezolizumab + Entinostat, 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
~18 spots leftby Oct 2025
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