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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ado-trastuzumab emtansine

Number of Participants of Clinically Relevant Toxicities (CRT)

Secondary outcome measures

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

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,360 Total Patients Enrolled

141 Trials studying Breast Cancer

22,105 Patients Enrolled for Breast Cancer

Sara Tolaney, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

7 Previous Clinical Trials

586 Total Patients Enrolled

6 Trials studying Breast Cancer

552 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab emtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01853748 — Phase 2

Breast Cancer Research Study Groups: Paclitaxel + Trastuzumab, Trastuzumab emtansine (T-DM1)

Breast Cancer Clinical Trial 2023: Trastuzumab emtansine Highlights & Side Effects. Trial Name: NCT01853748 — Phase 2

Trastuzumab emtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01853748 — Phase 2

Frequently Asked Questions

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

At how many different sites is this research project being conducted?

"Patients are currently being enrolled at Memorial Sloan Kettering Cancer Center-Basking Ridge in Basking Ridge, New jersey; Arnold Palmer Cancer Center-Greensburg in Greensburg, Pennsylvania; Vanderbilt-Ingram Cancer Center in Nashville, Tennessee; and 88 other sites."

Answered by AI

Is T-DM1 a safe cancer treatment for human patients?

"Trastuzumab emtansine (T-DM1) falls into a Phase 2 category. This means that while there is some data to support its safety, no studies have been done on its efficacy yet."

Answered by AI

Are there any unfilled vacancies for participants in this experiment?

"Unfortunately, this particular clinical trial is not presently enrolling patients. The study was initially posted on May 1st, 2013 and has since been edited on September 23rd, 2022. However, there are 2699 trials actively recruiting breast cancer patients and 1043 trials for Trastuzumab emtansine (T-DM1) that are looking for participants."

Answered by AI

What indications is T-DM1 most commonly used to treat?

"T-DM1, or trastuzumab emtansine, is a medication used to treat metastatic bladder cancer. However, it has also shown efficacy in treating other conditions such as inflammatory breast cancer (IBC), acquired immunodeficiency syndrome (AIDS), and advanced thymoma."

Answered by AI

What other investigations have been conducted with Trastuzumab emtansine (T-DM1)?

"As of the current moment, 1043 different trials are being conducted that research Trastuzumab emtansine (T-DM1). Of these ongoing studies, 271 are in Phase 3. The majority of clinical trials testing Trastuzumab emtansine (T-DM1) originate from Seattle, Washington; however, 56695 locations worldwide are running similar investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

Sara Tolaney, MD 2013. "T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01853748.

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