← Back to Search

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
Either the primary tumor and/or the metastasis must have been tested for ER, PR and HER2. Patient must have HER2+ breast cancer per ASCO CAP guidelines 2013
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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 below
Select...
My breast cancer is confirmed and has spread to other parts of my body.
Select...
My breast cancer is HER2 positive according to the 2013 guidelines.
Select...
I have been treated with trastuzumab and a taxane before.
Select...
I've had one treatment for my spreading breast cancer or it came back within 6 months after my last treatment.
Select...
I have never been treated with T-DM1.
Select...
My last chemotherapy was over 3 weeks ago.
Select...
I stopped all experimental or biologic treatments 3 weeks ago.
Select...
I have had radiation therapy before, either for early-stage or advanced cancer.
Select...
I finished my radiation therapy at least 14 days ago.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do active work.
Select...
My organ and bone marrow functions are normal.
Select...
My disease can be measured or evaluated in the current study phase.
Select...
I have a tumor that can be measured and hasn't been previously radiated.
Select...
I am currently taking bisphosphonates and can continue them during the study.

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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Disease Control Rate
Duration Of Response
Objective Response Rate
+2 more

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Upper respiratory tract infection
8%
Pneumonia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Hypokalaemia
7%
Abdominal pain
7%
Blood creatinine increased
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Nasopharyngitis
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Pulmonary embolism
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

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.

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
1,066 Previous Clinical Trials
338,998 Total Patients Enrolled
139 Trials studying Breast Cancer
21,544 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,843 Previous Clinical Trials
5,045,947 Total Patients Enrolled
57 Trials studying Breast Cancer
7,465 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

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03032107 — Phase 1
Breast Cancer Research Study Groups: Pembrolizumab Combine With Trastuzumab Emtansine
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03032107 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03032107 — Phase 1

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
~3 spots leftby Feb 2025