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Monoclonal Antibodies
Trastuzumab Emtansine vs. Trastuzumab for Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 years
Awards & highlights
Study Summary
This trial will compare the efficacy and safety of two different treatments for HER2-positive breast cancer.
Who is the study for?
This trial is for adults with HER2-positive breast cancer who still have tumor remnants in the breast or lymph nodes after preoperative therapy. They must have completed at least 6 cycles of specific chemotherapy, be within 12 weeks post-surgery, and not be pregnant or breastfeeding. Exclusions include metastatic cancer, recent investigational drug use, severe diseases, certain heart conditions, and prior adverse reactions to similar treatments.Check my eligibility
What is being tested?
The study compares trastuzumab emtansine (3.6 mg/kg) versus trastuzumab (6 mg/kg), both administered intravenously every three weeks for 14 cycles as additional treatment after surgery. The goal is to assess which treatment is more effective and safer for patients who've had preoperative therapy but still show signs of cancer.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, liver issues from hepatitis B or C infections if present before the trial starts, heart problems due to previous anthracycline use exceeding safe limits, and peripheral neuropathy—a nerve condition that can cause weakness or numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I completed at least 6 cycles of chemo over 16 weeks, including treatments specifically targeting HER2.
Select...
All visible cancer was surgically removed from my breast and lymph nodes.
Select...
I know my cancer's hormone-receptor status.
Select...
I am 18 years old or older.
Select...
My breast cancer is HER2-positive.
Select...
My breast cancer has been confirmed by a biopsy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I still have cancer in my breast or lymph nodes after initial treatment.
Select...
My surgery was less than 12 weeks ago.
Select...
My cancer is at an early or locally advanced stage but not the smallest size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 12 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive Disease-free Survival (IDFS)
Secondary outcome measures
Anti-trastuzumab Antibody (ATA)
Anti-trastuzumab Emtansine Antibody (ATA)
Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
+11 moreSide effects data
From 2016 Phase 3 trial • 1095 Patients • NCT0112018460%
Alopecia
49%
Diarrhoea
37%
Nausea
36%
Fatigue
28%
Neuropathy peripheral
28%
Oedema peripheral
26%
Arthralgia
24%
Rash
23%
Headache
23%
Myalgia
22%
Decreased appetite
21%
Cough
21%
Neutropenia
20%
Constipation
20%
Peripheral sensory neuropathy
20%
Vomiting
17%
Pyrexia
16%
Upper respiratory tract infection
16%
Asthenia
16%
Dyspnoea
16%
Stomatitis
15%
Epistaxis
15%
Dysgeusia
14%
Lacrimation increased
14%
Nasopharyngitis
14%
Insomnia
14%
Pain in extremity
13%
Back pain
12%
Paraesthesia
11%
Nail disorder
11%
Anaemia
11%
Dyspepsia
11%
Mucosal inflammation
10%
Dizziness
9%
Oedema
9%
Bone pain
9%
Abdominal pain upper
9%
Abdominal pain
9%
Ejection fraction decreased
9%
Pruritus
8%
Urinary tract infection
8%
Hot flush
8%
Oropharyngeal pain
8%
Lymphoedema
8%
Pain
7%
Erythema
7%
Non-cardiac chest pain
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Musculoskeletal pain
7%
Rhinorrhoea
7%
Dry skin
7%
Nail discolouration
6%
Anxiety
6%
Paronychia
6%
Conjunctivitis
5%
Influenza like illness
5%
Depression
5%
Hypertension
5%
Musculoskeletal chest pain
5%
Breast pain
5%
Rhinitis
4%
Pharyngitis
4%
Dry eye
4%
Hypokalaemia
4%
Onychoclasis
4%
Dry mouth
4%
Chills
4%
Febrile neutropenia
4%
Influenza
4%
Muscle spasms
4%
Bronchitis
3%
Aspartate aminotransferase increased
3%
Vertigo
3%
Neck Pain
3%
Haemorrhoids
3%
Vision Blurred
3%
Alanine aminotranseferase increased
2%
Weight decreased
2%
Dermatitis acneiform
1%
Anaphylactic reaction
1%
Herpes zoster
1%
Septic shock
1%
Gingival bleeding
1%
Pleural effusion
1%
Pulmonary embolism
1%
Pneumonia
1%
Cellulitis
1%
Neutropenic sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab + Taxane
Trastuzumab Emtansine + Pertuzumab
Trastuzumab Emtansine + Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Trastuzumab emtansineExperimental Treatment1 Intervention
Group II: TrastuzumabActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
trastuzumab emtansine
2010
Completed Phase 3
~1130
Find a Location
Who is running the clinical trial?
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
135,501 Total Patients Enrolled
44 Trials studying Breast Cancer
99,043 Patients Enrolled for Breast Cancer
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,087,567 Total Patients Enrolled
159 Trials studying Breast Cancer
89,980 Patients Enrolled for Breast Cancer
German Breast GroupOTHER
52 Previous Clinical Trials
46,836 Total Patients Enrolled
27 Trials studying Breast Cancer
35,085 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I completed at least 6 cycles of chemo over 16 weeks, including treatments specifically targeting HER2.All visible cancer was surgically removed from my breast and lymph nodes.I know my cancer's hormone-receptor status.My heart and lungs are not working properly as per the study's definition.I do not have any severe illnesses that are not under control.I do not have any active liver diseases like hepatitis or autoimmune disorders.I've had a severe allergic reaction to trastuzumab or similar medications.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am 18 years old or older.My breast cancer is HER2-positive.My breast cancer has been confirmed by a biopsy.My cancer has worsened despite treatment before surgery.I haven't had cancer in the last 5 years, except for certain types that were treated.I am fully active or restricted in physically strenuous activity but can do light work.My blood, kidney, and liver tests are within normal ranges.My heart pumps well after chemotherapy, with an ejection fraction of 50% or more.I still have cancer in my breast or lymph nodes after initial treatment.You need to provide documentation of whether you have been exposed to hepatitis B or hepatitis C virus.My breast cancer has spread to other parts of my body.I have had breast cancer before, but not lobular carcinoma in situ.My cancer is still visible or has come back after initial treatment and surgery.I have been exposed to high doses of specific chemotherapy drugs.I do not have serious infections or HIV.My surgery was less than 12 weeks ago.I have been treated with trastuzumab emtansine before.My cancer is at an early or locally advanced stage but not the smallest size.I am recommended to have radiotherapy for breast cancer but cannot due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Trastuzumab
- Group 2: Trastuzumab emtansine
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you give me the number of hospitals conducting this research?
"To participate in this study, you will need to go to one of the 79 clinics running it. The locations are listed on the website and include Ottawa, Marshfield, Lansing, and other cities. Please choose the location that is most convenient for you to minimize travel time and costs."
Answered by AI
Could you give an estimate as to how many people are included in this experiment?
"Unfortunately, this trial is not actively recruiting patients right now. However, if you are seeking other trials related to breast cancer or trastuzumab emtansine, there are 2754 and 223 studies enrolling candidates respectively."
Answered by AI
Has the Food and Drug Administration given their okay to use trastuzumab emtansine?
"As this is a Phase 3 trial, there is existing data affirming trastuzumab emtansine's efficacy and numerous rounds of safety trials. Consequently, our team has given it a score of 3 for safety."
Answered by AI
Are there other ongoing investigations using trastuzumab emtansine?
"In 1999, the first trial using trastuzumab emtansine was completed at Ospedale di Circolo e Fondazione Macchi. In total, there have been 372 trials completed as of now. Out of these, 223 are actively recruiting patients with a majority of these studies taking place in Ottawa, Canada."
Answered by AI
What is the most common reason that doctors prescribe trastuzumab emtansine?
"trastuzumab emtansine is most frequently used to treat breast cancer. However, it can also be an effective treatment for conditions such as high risk of recurrence, first line treatment, and surgery."
Answered by AI
Are there still patients being recruited for this clinical trial?
"As of September 19th, 2022, this clinical trial is no longer recruiting patients. It was originally posted on April 3rd, 2013. For individuals who are still interested in participating in clinical trials for breast cancer or trastuzumab emtansine, there are presently 2754 and 223 trials actively recruiting patients respectively."
Answered by AI
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