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Monoclonal Antibodies
Pembrolizumab + T-DM1 for Breast Cancer
Phase 1
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
Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
Subjects must have at least one lesion that is not within a previously radiated field that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST version 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well the combination of pembrolizumab and trastuzumab emtansine works in treating patients with breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults with stage IV breast cancer that has spread, who have previously been treated with trastuzumab and a taxane. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe allergies to the drugs being tested. Participants should not have untreated brain metastases or active infections requiring IV antibiotics.Check my eligibility
What is being tested?
The study tests Pembrolizumab in combination with Trastuzumab emtansine (T-DM1) as a treatment for metastatic breast cancer. It aims to see if this drug duo can help patients whose tumors are HER2 positive and who may have had prior treatments.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, potential lung issues like non-infectious pneumonitis, liver or kidney problems due to toxicity, fatigue from treatment, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is confirmed and has spread to other parts of my body.
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I have a tumor that can be measured and hasn't been previously radiated.
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My breast cancer is HER2 positive according to the 2013 guidelines.
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I can take care of myself but might not be able to do active work.
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My last chemotherapy was over 3 weeks ago.
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I have never been treated with T-DM1.
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I finished my radiation therapy at least 14 days ago.
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I have been treated with trastuzumab and a taxane before.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Disease Control Rate
Duration Of Response
Objective Response Rate
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab Combine With Trastuzumab EmtansineExperimental Treatment2 Interventions
Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
Pembrolizumab will be administered prior to T-DM1 administration
Pembrolizumab will be given at a predetermine dose
T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
T-DM1 will be given at a predetermine dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab emtansine
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,845 Total Patients Enrolled
141 Trials studying Breast Cancer
22,590 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,544 Total Patients Enrolled
58 Trials studying Breast Cancer
7,507 Patients Enrolled for Breast Cancer
Sara Tolaney, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
165 Total Patients Enrolled
3 Trials studying Breast Cancer
165 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong CYP3A4 inhibitors while on T-DM1 treatment.I am on long-term steroids or other drugs that weaken my immune system.Your heart's pumping ability must be normal, as checked by a heart ultrasound or MUGA scan within 28 days before starting the study drug.I have moderate to severe nerve damage.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.You have a current infection of Hepatitis B or Hepatitis C.You have HIV.The bone abnormalities cannot be accurately measured.I have had radiation therapy before, either for early-stage or advanced cancer.My disease can be measured or evaluated in the current study phase.I am currently taking bisphosphonates and can continue them during the study.I have not had another type of cancer, or if I did, it meets certain conditions.I have an autoimmune disease that needs steroids or other immune-suppressing drugs.My breast cancer is confirmed and has spread to other parts of my body.My organ and bone marrow functions are normal.I have a tumor that can be measured and hasn't been previously radiated.I have a history of lung inflammation not caused by an infection.You are allergic to pembrolizumab or T-DM1 or any of the substances used to make them.My breast cancer is HER2 positive according to the 2013 guidelines.I have not received a live vaccine in the last 28 days.I can take care of myself but might not be able to do active work.My last chemotherapy was over 3 weeks ago.I have been diagnosed with cancer that has spread to the lining of my brain and spinal cord.I have never been treated with T-DM1.I finished my radiation therapy at least 14 days ago.I do not have any uncontrolled illnesses like high blood pressure or heart problems.I stopped all experimental or biologic treatments 3 weeks ago.I have been treated with trastuzumab and a taxane before.I am not on IV antibiotics for an infection as of the first day of treatment.I have previously been treated with pembrolizumab or similar therapies.I've had one treatment for my spreading breast cancer or it came back within 6 months after my last treatment.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab Combine With Trastuzumab Emtansine
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are enrollment opportunities for this research project available now?
"Unfortunately, this study has now ended its recruitment phase. Its initial post was made on February 17th 2017 and the last update to it occurred on July 25th 2022. However, if you are still seeking clinical trials related to breast cancer there are presently 2,600 studies actively recruiting patients and 999 for Pembrolizumab alone."
Answered by AI
To what maladies has Pembrolizumab been employed to offer relief?
"Pembrolizumab is commonly employed to tackle cancerous neoplasms, but it can also be used for treating advanced melanoma cases, those with high levels of microsatellite instability, and for responding inadequately to chemotherapy."
Answered by AI
Has this type of experiment been performed before?
"Pembrolizumab was initially studied back in 2008, with Hoffmann-La Roche sponsoring the first trial which included 720 patients. After Phase 2 drug approval had been granted, it has since become an active research subject in 68 countries and 3281 cities - currently featuring 999 studies."
Answered by AI
What precedent literature exists on the efficacy of Pembrolizumab?
"At the current moment, over 999 clinical trials are running related to Pembrolizumab. Of those studies, 131 have entered Phase 3. Primarily based in Rochester, Minnesota, data from 41689 locations offer insight into this drug's performance."
Answered by AI
Could you elucidate the potential risks of Pembrolizumab for participants?
"The safety standings of Pembrolizumab is classified as a 1, due to the limited amount of clinical data that supports both its efficacy and potential hazards."
Answered by AI
How many participants are being accepted into this clinical trial?
"As of the last update on July 25th 2022, this clinical trial is no longer seeking participants. However, if you are looking for alternative trials there are 2,600 studies involving breast cancer and 999 studies utilizing pembrolizumab with open recruitment."
Answered by AI
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