← Back to Search

Monoclonal Antibodies

Trastuzumab Emtansine for Cancer

Phase 2
Waitlist Available
Led By Komal Jhaveri
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after completion of study
Patients must have echocardiography (ECHO) or nuclear study (multigated acquisition scan [MUGA] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < 50% to be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing if ado-trastuzumab emtansine can shrink or stop the growth of cancer that has a genetic change called HER2 amplification.

Who is the study for?
This trial is for patients with cancers like lymphoma or solid tumors that have a specific genetic change (HER2 amplification). They must not have had certain prior treatments, agree to use contraception, and meet health criteria such as adequate hemoglobin levels and heart function. People with breast or gastric cancer, severe allergies to the drug being tested, or serious nerve damage are excluded.Check my eligibility
What is being tested?
Researchers are testing ado-trastuzumab emtansine in this phase II trial to see if it can shrink tumors or halt their growth in cancers with HER2 changes. This drug combines trastuzumab (a targeted therapy) with a chemotherapy agent DM1 to attack cancer cells directly.See study design
What are the potential side effects?
Ado-trastuzumab emtansine may cause side effects including allergic reactions due to its components, potential heart problems from trastuzumab attachment on cancer cells' receptors, liver issues from the chemotherapy part DM1, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use effective birth control or abstain from sex during and for 7 months after the study.
Select...
My heart's pumping ability is confirmed to be normal by a recent heart scan.
Select...
My hemoglobin level is at least 9.0 g/dL.
Select...
My tumor has a high level of HER2 based on a specific genetic test.
Select...
I am on blood thinners (not warfarin) or take 81 mg aspirin daily.
Select...
My recent ECG showed no significant heart issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 3 cycles for the first 33 cycles and every 4 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
6 Months Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)

Side effects data

From 2018 Phase 3 trial • 444 Patients • NCT02131064
74%
Diarrhoea
67%
Alopecia
63%
Nausea
43%
Fatigue
37%
Anaemia
31%
Vomiting
28%
Asthenia
27%
Neutropenia
26%
Rash
22%
Stomatitis
21%
Radiation skin injury
21%
Hot flush
20%
Constipation
20%
Dysgeusia
19%
Arthralgia
18%
Decreased appetite
17%
Myalgia
17%
Headache
16%
Pyrexia
14%
Mucosal inflammation
14%
Oedema peripheral
14%
Abdominal pain
14%
Insomnia
13%
Neuropathy peripheral
12%
Platelet count decreased
12%
Peripheral sensory neuropathy
12%
Febrile neutropenia
12%
Dizziness
12%
Dry skin
12%
Pruritus
11%
Nasopharyngitis
11%
Thrombocytopenia
11%
Paraesthesia
11%
Alanine aminotransferase increased
11%
Weight decreased
11%
Epistaxis
10%
Neutrophil count decreased
10%
Abdominal pain upper
10%
Cough
10%
Aspartate aminotransferase increased
9%
Back pain
9%
Hypokalaemia
9%
Hypoaesthesia
9%
Nail discolouration
9%
Musculoskeletal pain
8%
Lacrimation increased
8%
Urinary tract infection
8%
White blood cell count decreased
8%
Bone pain
8%
Dyspnoea
7%
Dyspepsia
7%
Upper respiratory tract infection
7%
Depression
7%
Gastrooesophageal reflux disease
7%
Dermatitis acneiform
7%
Hypertension
6%
Muscle spasms
6%
Hypomagnesaemia
6%
Haemorrhoids
6%
Pain in extremity
6%
Anxiety
6%
Dry eye
5%
Influenza like illness
5%
Breast pain
5%
Oropharyngeal pain
5%
Nail disorder
5%
Hypersensitivity
5%
Rhinorrhoea
4%
Chills
4%
Erythema
2%
Dry mouth
1%
Left ventricular dysfunction
1%
Cardiac failure
1%
Colitis
1%
Cellulitis
1%
Pneumonia
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCH + P
T-DM1 + P

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab emtansine)Experimental Treatment1 Intervention
Patients receive trastuzumab emtansine IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Emtansine
2016
Completed Phase 3
~5630

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,608 Total Patients Enrolled
Komal JhaveriPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Trastuzumab Emtansine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04439110 — Phase 2
Cancer Research Study Groups: Treatment (trastuzumab emtansine)
Cancer Clinical Trial 2023: Trastuzumab Emtansine Highlights & Side Effects. Trial Name: NCT04439110 — Phase 2
Trastuzumab Emtansine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439110 — Phase 2

Frequently Asked Questions

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

How many individuals are allowed to enroll in this clinical trial?

"This study is not currently enrolling patients. However, it is still possible to find other trials; as of right now, there are 4810 clinical trials for refractory lymphomas and 43 for Trastuzumab Emtansine that are actively looking for participants."

Answered by AI

Are there harmful side effects associated with Trastuzumab Emtansine?

"Trastuzumab Emtansine is at a Phase 2 in terms of testing, so while there is some data supporting its safety, none supports its efficacy. Our team rates it as a 2 on our scale."

Answered by AI

What are the precedent studies for Trastuzumab Emtansine?

"As of now, 43 clinical trials are underway to research Trastuzumab Emtansine. Of these, 9 are in Phase 3. Most of the studies for Trastuzumab Emtansine are located in Brewer, Maine; however, there are 6088 locations running clinical trials for Trastuzumab Emtansine across the world."

Answered by AI

Has this research been conducted before?

"Trastuzumab Emtansine has undergone 43 clinical trials in 1456 cities and 57 countries since the first study in 2008. The initial trial, sponsored by Hoffmann-La Roche, completed Phase 2 drug approval stage with 720 patients. In the 12 years since then, 36 more studies have been conducted."

Answered by AI

Are participants being accepted for this experiment at this time?

"This particular study is not enrolling patients at the current moment. However, it is important to note that there are 4810 other clinical trials for refractory lymphomas and 43 trials for Trastuzumab Emtansine still admitting participants."

Answered by AI
~4 spots leftby Mar 2025