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Monoclonal Antibodies

Atezolizumab + Trastuzumab Emtansine for Breast Cancer (Astefania Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)

Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%

Must not have

Any known active liver disease

Current grade >=2 peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of cycles 1 and 4 pre-infusion, day 1 of cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after cycle 1 day 1)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug to see if it can shrink breast tumors before surgery in people who have already had chemotherapy and a HER2-targeted therapy.

Who is the study for?

This trial is for individuals with HER2-positive breast cancer who've had preoperative chemotherapy and surgery but still have invasive disease. They should be in good health, with a life expectancy of at least 6 months, and must not have stage IV cancer or a history of certain other cancers within the last 5 years.

What is being tested?

The study tests if Atezolizumab (an immunotherapy drug) or placebo, combined with Trastuzumab Emtansine (a targeted therapy), can prevent cancer recurrence in patients post-surgery. Participants are randomly assigned to one of two groups and treatment efficacy and safety are compared.

What are the potential side effects?

Atezolizumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, liver issues, and infections. Trastuzumab Emtansine can lead to heart problems, liver issues, low blood cell counts causing increased infection risk or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I've completed chemotherapy including treatments with taxane and trastuzumab.

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My heart's pumping ability is within the normal range.

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My breast cancer has been confirmed by tissue analysis.

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My breast cancer is confirmed to be HER2-positive.

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My cancer is at a specific stage but not the earliest or with minimal invasion.

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My cancer was at an advanced stage before starting treatment, but it had not spread to distant parts of my body.

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I am fully active or can carry out light work.

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My cancer's PD-L1 and hormone receptor status have been confirmed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active liver disease.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I am currently taking or have taken drugs that affect my immune system.

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I have been treated with T-DM1, atezolizumab, or similar drugs.

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My breast cancer is at stage IV.

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I have heart or lung problems.

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I have a history of lung scarring or inflammation.

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I have been treated with anthracyclines before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of cycles 1 and 4 pre-infusion, day 1 of cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after cycle 1 day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of cycles 1 and 4 pre-infusion, day 1 of cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after cycle 1 day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of cycles 1 and 4 pre-infusion, day 1 of cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after cycle 1 day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)

Secondary study objectives

Cmax for DM1

IDFS in the PD-L1-positive and the PD-L1-negative Population

Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30

+2 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Atezolizumab + Trastuzumab EmtansineExperimental Treatment3 Interventions

Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Group II: Arm A: Placebo + Trastuzumab EmtansineActive Control3 Interventions

Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Trastuzumab

2014

Completed Phase 4

~5190