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Anti-tumor antibiotic

T-DM1 vs TH for Breast Cancer

Phase 2

Recruiting

Led By Sara Tolaney, MD, PhD

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

All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy with clear margins

Patients with a micrometastasis found by sentinel node evaluation are eligible

Must not have

Patients with a history of previous invasive breast cancer

Patients with active liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to end of treatment up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two different combination of HER2-directed therapies to see how well they work in treating patients with newly diagnosed breast cancer.

Who is the study for?

This trial is for adults with HER2-positive, Stage I breast cancer that's been surgically removed and has no lymph node involvement or only micrometastases. Participants must have good liver and bone marrow function, clear surgical margins, an ECOG status of 0 or 1, and a heart ejection fraction ≥50%. It excludes those with prior chemotherapy within 5 years, certain other cancers, active severe illnesses, pregnant/nursing women, or those not using contraception.

What is being tested?

The ATEMPT 2.0 study compares two post-surgery treatments for early-stage HER2-positive breast cancer: Trastuzumab-emtansine (T-DM1) versus a combination of Subcutaneous Trastuzumab (Herceptin Hylecta) and Paclitaxel. The goal is to see which therapy better prevents cancer recurrence.

What are the potential side effects?

Possible side effects include fatigue; nausea; muscle pain; bleeding issues; liver problems from T-DM1; infusion reactions from Herceptin Hylecta like chills or fever; neuropathy (nerve damage), hair loss, allergic reactions from Paclitaxel.

Eligibility Criteria

Inclusion Criteria

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

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My tumor was completely removed with surgery and the edges were cancer-free.

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My cancer has spread to nearby lymph nodes, as found by a sentinel node test.

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My cancer is confirmed HER2 positive by a central lab.

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My cancer's hormone receptor status was tested.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am premenopausal and have a negative pregnancy test.

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My breast cancer is HER2-positive, early stage, and has not spread to lymph nodes or only has tiny cancer cells in them.

Exclusion Criteria

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

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I have had breast cancer before.

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I have an active liver condition.

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I have had chemotherapy or paclitaxel therapy in the last 5 years.

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My cancer was advanced but localized when diagnosed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to end of treatment up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to end of treatment up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of treatment up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease Free Survival (DFS)

Incidence of clinically relevant toxicities (CRT)

Secondary study objectives

Effect of alopecia on patients

Therapeutic procedure

Evaluation of gene predictors of trastuzumab-emtansine-induced grade 2-4

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC aloneExperimental Treatment2 Interventions

Randomized participants will receive weekly intravenous Paclitaxel for 12 weeks (4 cycles) and Trastuzumab SC (subcutaneous) every 3 weeks for 17 cycles. The first 4 doses Trastuzumab SC are given with Paclitaxel.

Group II: Arm A. T-DM1 followed by Trastuzumab SCExperimental Treatment2 Interventions

Randomized participants will receive intravenous T-DM1 every 3 weeks for 6 cycles (18 weeks) and then Trastuzumab SC (subcutaneous) every 3 weeks for 11 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Trastuzumab SC

2018

Completed Phase 3

~500