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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Free Survival (DFS)
Incidence of clinically relevant toxicities (CRT)
Secondary outcome measures
Effect of alopecia on patients
Therapeutic procedure
Evaluation of gene predictors of trastuzumab-emtansine-induced grade 2-4
+10 more

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
Trastuzumab SC
2018
Completed Phase 3
~500
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,373 Total Patients Enrolled
141 Trials studying Breast Cancer
22,117 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,253 Total Patients Enrolled
96 Trials studying Breast Cancer
22,718 Patients Enrolled for Breast Cancer
Sara Tolaney, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute, Massachusetts General Hospital

Media Library

Paclitaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04893109 — Phase 2
Breast Cancer Research Study Groups: Arm A. T-DM1 followed by Trastuzumab SC, Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC alone
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT04893109 — Phase 2
Paclitaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893109 — Phase 2

Frequently Asked Questions

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

Does this research endeavor seek to bring on new participants?

"Confirmed, clinicaltrials.gov states that this trial is presently enrolling patients. The original advertisement was posted on June 16th 2021 and has been revised as recently as October 19th 2022. 500 individuals are sought from 28 distinct treatment sites."

Answered by AI

Could you provide an assessment of the risks associated with trastuzumab-emtansine use?

"Trastuzumab-emtansine was given a safety score of 2, as clinical trials have not yet provided evidence for efficacy but earlier rounds have established its security."

Answered by AI

How many individuals are eligible to partake in this scientific endeavor?

"The sponsor, Genentech Inc., aims to recruit 500 eligible patients from two spots: Dana-Farber Brigham Cancer Center - Foxborough in Foxboro, Massachusetts and NH Oncology - Hematology in Concord, New hampshire."

Answered by AI

How extensively is this exploratory trial being conducted across the medical community?

"28 clinics across the United States are currently recruiting participants for this trial. This includes locations in Foxboro, Concord and Manchester as well as 25 other sites, so finding a clinic in your vicinity should not be difficult."

Answered by AI

What objectives is this investigation trying to accomplish?

"This research aims to assess the occurrence of clinically relevant toxicities (CRT). Additionally, investigators will assess the effect of therapy on work productivity utilizing the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), measure grade 3-4 cardiac left ventricular dysfunction in patients treated with adjuvant trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel with trastuzumab SC, and analyze genomic profiling via a large panel of cancer gene mutations and gene expression in Stage I HER2-positive breast cancer sufferers over a 72 month"

Answered by AI

What has trastuzumab-emtansine been primarily utilized to treat?

"trastuzumab-emtansine is conventionally used to alleviate symptoms of cyclophosphamide, but also holds potential for rehydration, advanced non-small cell lung cancer and metastatic bladder cancer."

Answered by AI

Could you elaborate on the additional investigations concerning trastuzumab-emtansine?

"Since 1997, trastuzumab-emtansine has been investigated through 1470 trials, many of which are currently taking place in Foxboro, Massachusetts. In total there have been 1024 live studies conducted on the drug since its conception."

Answered by AI
~141 spots leftby May 2025