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Alkylating agents
Pembrolizumab + Chemotherapy for Breast Cancer
Phase 2
Waitlist Available
Led By Elias Obeid, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients are candidates for chemotherapy with carboplatin and gemcitabine
Have either Evaluable disease, or have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST (version v1.1)
Must not have
History of any lymphoproliferative disorder
Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until death (assessed up to 60 months.)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effectiveness of Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) in patients with metastatic triple negative breast cancer.
Who is the study for?
This trial is for women over 18 with metastatic triple negative breast cancer who haven't had certain treatments in the last few weeks and have adequate organ function. They must not be pregnant, agree to use birth control, and provide tissue samples. Exclusions include other active cancers, severe health conditions, or recent participation in another investigational study.
What is being tested?
The trial tests Pembrolizumab combined with chemotherapy drugs Carboplatin and Gemcitabine for safety and effectiveness against metastatic triple negative breast cancer. Pembrolizumab has been used for melanoma and lung cancer but isn't yet approved for breast cancer treatment.
What are the potential side effects?
Potential side effects may include immune system reactions that can affect organs, infusion-related responses, fatigue, nausea or vomiting from chemotherapy drugs. Each patient's experience with side effects could vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for chemotherapy with carboplatin and gemcitabine.
Select...
My cancer can be measured by scans.
Select...
My cancer has spread and cannot be removed by surgery.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I have had up to 2 treatments for my cancer after it spread.
Select...
My breast cancer is triple negative for ER, PR, and HER2.
Select...
My cancer is hormone receptor negative and HER2 negative.
Select...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
My cancer progressed despite treatment with carboplatin or cisplatin, or I received carboplatin/gemcitabine within the last year.
Select...
I have moderate nerve pain or tingling.
Select...
My breast cancer is hormone-receptor positive and HER-2 positive.
Select...
I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.
Select...
I have a lung condition not caused by an infection.
Select...
I haven't had cancer treatment in the last 2 weeks or still have side effects.
Select...
I have had another cancer that got worse or needed treatment in the past 5 years.
Select...
I have previously been treated with specific immune therapy drugs.
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I agree to give tissue samples before and after treatment for research.
Select...
I have a history of cancer.
Select...
I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment until death (assessed up to 60 months.)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment until death (assessed up to 60 months.)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Related Adverse Events
Objective Response Rate
Secondary study objectives
Clinical Benefit Rate
Overall Survival
Progression Free Survival
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab with Standard ChemotherapyExperimental Treatment3 Interventions
Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
Group II: Standard Chemotherapy AloneActive Control2 Interventions
Standard chemotherapy alone using carboplatin and gemcitabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Carboplatin
2014
Completed Phase 3
~6120
Gemcitabine
2017
Completed Phase 3
~1920
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonOTHER
1,226 Previous Clinical Trials
3,168,587 Total Patients Enrolled
Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,286 Total Patients Enrolled
Elias Obeid, MDPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a weakened immune system or have been on steroids or other immune-weakening drugs in the last 4 weeks.I am eligible for chemotherapy with carboplatin and gemcitabine.My cancer can be measured by scans.My cancer has spread and cannot be removed by surgery.I can take care of myself and am up and about more than half of the day.I am using two birth control methods or am not having sex to join this study.You live outside the United States.I have had a condition where my lymphocytes grow abnormally.I haven't had any cancer except for skin cancer in the last 5 years.I have had up to 2 treatments for my cancer after it spread.My recent blood tests show my organs are working well.My cancer progressed despite treatment with carboplatin or cisplatin, or I received carboplatin/gemcitabine within the last year.You are expected to live for less than 3 months.You are currently abusing drugs or have serious mental health issues.I have moderate nerve pain or tingling.I have a lung condition not caused by an infection.I have not received a live vaccine in the last 30 days.I agree to give tissue samples before and after treatment for research.My breast cancer is triple negative for ER, PR, and HER2.I have given a tissue sample for the study and agree to provide another after 2 treatment cycles.My breast cancer is hormone-receptor positive and HER-2 positive.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I haven't had a monoclonal antibody treatment in the last 4 weeks or still have side effects from one taken more than 4 weeks ago.I have cancer that has spread to my brain or spinal cord.I haven't had cancer treatment in the last 2 weeks or still have side effects.I have fully recovered from any major surgery before starting treatment.I have had another cancer that got worse or needed treatment in the past 5 years.I have previously been treated with specific immune therapy drugs.My cancer is hormone receptor negative and HER2 negative.I have a history of cancer.You have hepatitis B or C virus.I am currently being treated for an infection.I am older than 18 years.You have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab with Standard Chemotherapy
- Group 2: Standard Chemotherapy Alone
Awards:
This trial has 1 awards, including:- 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.
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