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Antibody-Drug Conjugate

T-DM1 for Breast Cancer

Phase 2
Waitlist Available
Led By Rachel Freedman, 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
Age ≥60 years at the time of study registration (men and women eligible)
ECOG Performance Status (PS) 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying T-DM1 to see how well it works compared to standard treatment in treating patients with HER2-positive breast cancer.

Who is the study for?
This trial is for individuals aged 60 or older with HER2-positive Stage I-III breast cancer who haven't had metastatic disease, prior invasive breast cancer within 5 years, or certain treatments like neoadjuvant chemotherapy. They must have an ECOG Performance Status of 0-2 and be willing to use birth control and provide blood samples.Check my eligibility
What is being tested?
The ATOP TRIAL is evaluating the investigational drug ado-trastuzumab emtansine (T-DM1) as a potential treatment for patients with HER2-positive breast cancer who either declined standard therapy or are not candidates for it.See study design
What are the potential side effects?
Potential side effects of T-DM1 may include reactions related to infusion such as fever and chills, liver issues, heart problems, fatigue, low blood cell counts leading to increased infection risk, bleeding issues, and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I can take care of myself and perform daily activities.
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I have taken a pregnancy test in the last week and it was negative.
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My cancer is HER2 positive, confirmed by tests and a specialist review.
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My breast cancer is confirmed and falls within Stage I-III, meeting specific size and node criteria.
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My tumor was completely removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
5-year invasive disease-free survival rate
Secondary outcome measures
Incidence Rate of Cardiac-Related Adverse Events (cardiac death)
Incidence Rate of Cardiac-Related Adverse Events (decreased ejection fraction)
Incidence Rate of Cardiac-Related Adverse Events (left ventricular systolic dysfunction)
+4 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT02073487
69%
Liver Function Abnormality
50%
Fatigue
44%
Diarrhea
38%
Hypokalemia
19%
Neuropathy
19%
Rash
19%
Nausea
6%
Breast pain
6%
Musculoskeletal pain
6%
Hypomagnesemia
6%
Mucositis
6%
Depression
6%
Anxiety
6%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab + Pertuzumab + Paclitaxel
T-DM1 + Lapatinib + Abraxane

Trial Design

1Treatment groups
Experimental Treatment
Group I: T-DM1Experimental Treatment1 Intervention
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-DM1
2014
Completed Phase 2
~450

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,790 Total Patients Enrolled
141 Trials studying Breast Cancer
22,535 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
65 Previous Clinical Trials
217,106 Total Patients Enrolled
40 Trials studying Breast Cancer
214,990 Patients Enrolled for Breast Cancer
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,488 Total Patients Enrolled
5 Trials studying Breast Cancer
269 Patients Enrolled for Breast Cancer

Media Library

T-DM1 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03587740 — Phase 2
Breast Cancer Research Study Groups: T-DM1
Breast Cancer Clinical Trial 2023: T-DM1 Highlights & Side Effects. Trial Name: NCT03587740 — Phase 2
T-DM1 (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587740 — Phase 2

Frequently Asked Questions

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

Has the Food and Drug Administration approved T-DM1 for patient use?

"T-DM1's safety rating is a 2 on our scale, as the compound has been tested for efficacy in Phase 2 trials and data supporting its security exists."

Answered by AI

Does this experiment represent an unprecedented medical exercise?

"Since its initial study in 2008 sponsored by Hoffmann-La Roche, T-DM1 has gone through rigorous testing and is now accepted for Phase 2 drug approval. Today, 41 active studies are ongoing across 1451 cities located in 57 countries."

Answered by AI

What former investigations have been conducted concerning T-DM1?

"T-DM1 was initially researched in 2008 at SCRI Tennessee Oncology Chattanooga. To date, there are 36 completed trials and an additional 41 currently active studies primarily occuring in Chapel Hill, North carolina."

Answered by AI

How many healthcare facilities are currently conducting this experiment?

"This trial is currently being conducted at 15 different centres, including Chapel Hill, Boston and Londonderry. To lessen travel requirements for enrolled patients, it's advised to pick a site closest to you."

Answered by AI

Are there any openings currently available to join this clinical trial?

"Presently, this research is not actively accepting patients. It was initially posted on August 22nd 2018 and the latest update occurred in late 2022. If you're looking for other options, there are 2596 clinical trials recruiting individuals with breast cancer as well as 41 studies utilizing T-DM1 that still have open spots available."

Answered by AI

How many participants are invited to join this clinical research?

"This clinical trial has concluded its recruitment process. It was initially posted on August 22nd, 2018 before being last updated nearly 4 years later on August 25th 2022. Currently, there are 2,596 trials searching for patients with breast cancer and 41 studies looking to recruit those suffering from T-DM1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer
Rachel Freedman, MD, MPH 2018. "ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587740.
~24 spots leftby Aug 2026
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