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Monoclonal Antibodies

T-DM1 for Breast Cancer

Phase 2

Waitlist Available

Led By Sara Tolaney, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing

HER2-positive Stage I histologically confirmed invasive carcinoma of the breast

Must not have

Active cardiac disease

History of prior chemotherapy in the past 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median follow-up was 3.9 years. the ae data cutoff date is 21 april 2020.

Awards & highlights

No Placebo-Only Group

Summary

This trialis testing a drug to see if it works to treat a specific cancer. It has been used in other studies but not yet approved by the FDA. It's being compared to existing treatments to see if it has less side effects and better long-term benefits.

Who is the study for?

This trial is for individuals with HER2-positive Stage I breast cancer, who have had recent surgery and may have started hormonal therapy. They must not be pregnant or breastfeeding, free from certain other cancers for 5 years, without active infections or liver disease, and agree to use effective contraception.

What is being tested?

The ATEMPT trial is testing the effectiveness of T-DM1 (an investigational drug) against the standard treatment combination of paclitaxel and trastuzumab in preventing breast cancer recurrence. It's a Phase II study comparing side effects and long-term benefits.

What are the potential side effects?

T-DM1 can cause liver issues, fatigue, bleeding problems, low blood cell counts leading to increased infection risk. Paclitaxel/Trastuzumab may lead to allergic reactions, nerve damage, heart problems, muscle pain.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor sample large enough to make 15 slides for testing.

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My breast cancer is HER2-positive and at Stage I.

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My cancer is HER2 positive based on specific test results.

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I had surgery to remove my breast tumor and check the nearby lymph nodes.

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I agree to use effective nonhormonal birth control during and for 7 months after the study.

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I am having a lumpectomy and can safely receive radiation therapy.

Exclusion Criteria

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

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I have a heart condition that is currently causing symptoms.

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I have had chemotherapy within the last 5 years.

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I have previously been treated with trastuzumab or paclitaxel.

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I have an active liver condition.

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I currently have an infection that is not getting better.

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I am not taking strong CYP3A4 inhibitor medications during the study.

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My cancer was advanced but confined to one area when diagnosed.

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I have had breast cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median follow-up was 3.9 years. the ae data cutoff date is 21 april 2020.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median follow-up was 3.9 years. the ae data cutoff date is 21 april 2020.

This trial's timeline: 3 weeks for screening, Varies for treatment, and median follow-up was 3.9 years. the ae data cutoff date is 21 april 2020. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ado-trastuzumab emtansine

Number of Participants of Clinically Relevant Toxicities (CRT)

Secondary study objectives

3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status

Gene Mutation Assessed Using High-throughput Mutation Profiling System (Oncomap)

Incidence Rate of Grade 3-4 Treatment-Related Toxicity

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Paclitaxel + TrastuzumabActive Control2 Interventions

paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

Group II: Trastuzumab emtansine (T-DM1)Active Control1 Intervention

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

0 / 14Eligibility criteria met