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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 10 years
Awards & highlights

Astefania 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.Check my eligibility
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.See study design
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.

Astefania Trial 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.
Select...
My breast cancer is confirmed to be HER2-positive.
Select...
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.

Astefania Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-free Survival (IDFS)
Secondary outcome measures
Cmax for DM1
Cmax for Total Trastuzumab
Cmax for Trastuzumab Emtansine
+12 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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Astefania 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
2017
Completed Phase 3
~5860
Trastuzumab
2014
Completed Phase 4
~5190
Trastuzumab Emtansine
2016
Completed Phase 3
~5630

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,088,523 Total Patients Enrolled
159 Trials studying Breast Cancer
89,742 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,240 Total Patients Enrolled
137 Trials studying Breast Cancer
70,396 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04873362 — Phase 3
Breast Cancer Research Study Groups: Arm B: Atezolizumab + Trastuzumab Emtansine, Arm A: Placebo + Trastuzumab Emtansine
Breast Cancer Clinical Trial 2023: Trastuzumab Highlights & Side Effects. Trial Name: NCT04873362 — Phase 3
Trastuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873362 — Phase 3

Frequently Asked Questions

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

Does Trastuzumab have a previous history of being studied?

"Trastuzumab was first studied in 1999. As of right now, there have been 18703 completed studies and 559 active studies. The majority of the ongoing trials are based in Newport News, Virginia."

Answered by AI

What are the most common maladies that Trastuzumab is used to fight?

"Trastuzumab is frequently used to treat brca1 gene. However, it can also be an effective form of pharmacotherapy for inflammatory breast cancer (ibc) and small cell lung cancer (sclc)."

Answered by AI

Will this research project be enrolling new participants soon?

"That is accurate, the online information does show that the trial is ongoing and that they are looking for 1700 individuals from 50 different centres. According to the website, the trial was first posted on May 4th, 2021 and was last updated on November 4th, 2022."

Answered by AI

Are there any short-term or long-term risks to Trastuzumab use?

"As this is a Phase 3 trial, there is both evidence of efficacy and multiple rounds of data supporting safety, thus our team rates the safety of Trastuzumab to be a 3."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
2021. "A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04873362.
All > Breast Cancer High Point
~697 spots leftby Jun 2026
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