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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment until death (assessed up to 60 months.)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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My cancer can be measured by scans.
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My cancer has spread and cannot be removed by surgery.
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I can take care of myself and am up and about more than half of the day.
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I have had up to 2 treatments for my cancer after it spread.
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My breast cancer is triple negative for ER, PR, and HER2.
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My cancer is hormone receptor negative and HER2 negative.
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I am older than 18 years.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Related Adverse Events
Objective Response Rate
Secondary outcome measures
Clinical Benefit Rate
Overall Survival
Progression Free Survival
Other outcome measures
Assessment of Association of PD-L1 Expression with Clinical Benefit Rate
Assessment of Association of PD-L1 Expression with Overall Survival
Assessment of Association of PD-L1 Expression with Progression Free Survival
Side 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
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 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonOTHER
1,184 Previous Clinical Trials
3,169,381 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,422 Total Patients Enrolled
15 Trials studying Breast Cancer
4,082 Patients Enrolled for Breast Cancer
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many sites is this trial being conducted?
"Right now, this clinical trial is looking for patients from 6 different hospitals. A few of these locations are Indianapolis, the Bronx and Durham. If you decide to participate in this study, try and choose a location close to reduce travel time."
Answered by AI
Could you tell us about other recent Pembrolizumab clinical trials?
"As of right now, Pembrolizumab is being trialled in 409 different Phase 3 clinical trials, 1955 total. The majority of these studies are based out of Shanghai but there are 84291 locations around the world running active trials for this treatment."
Answered by AI
Are there any patients that can still join this trial?
"Yes, this clinical trial is still recruiting participants. The initial posting was on May 31st, 2016 with the latest update happening on November 1st, 2022."
Answered by AI
How is Pembrolizumab most often employed?
"Pembrolizumab is frequently used to treat non-hodgkin lymphoma but can also be an effective for malignant melanoma of skin, recurrent cervical cancer, and refractory, relapsed mediastinal large b-cell lymphoma."
Answered by AI
How many individuals are part of this research project?
"Eighty-seven patients that meet the prerequisites for this study are required for it to be completed. These participants can come from different medical facilities, like Indiana University in Indianapolis, Indiana or Montefiore Medical Center in Bronx, New york."
Answered by AI
What is Pembrolizumab's standing with the FDA?
"Pembrolizumab safety is contested because there is a lack of data supporting its efficacy. Our team rates it as a 2."
Answered by AI
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