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Chemotherapy

Pembrolizumab for Breast Cancer

Phase 2
Waitlist Available
Led By Elizabeth C Dees, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test if the cancer-fighting drug pembrolizumab works well in patients with triple-negative breast cancer who have tried other treatments before.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Body Weight Changes
The Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Response Rate (ORR)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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: Experimental: Single ArmExperimental Treatment2 Interventions
Subjects will receive a single dose (300 mg/m2) of cyclophosphamide given the day before cycle 1 of pembrolizumab (200 mg), which will be administered every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,293 Total Patients Enrolled
52 Trials studying Breast Cancer
27,986 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,017 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Elizabeth C Dees, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
47 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what maladies has Pembrolizumab been found efficacious?

"Pembrolizumab is a viable therapeutic option for those with malignant melanoma of the skin, recurrent cervical cancer and leukemia."

Answered by AI

How many people are involved in the current trial?

"This clinical trial is not currently open for enrollment. It was initially published on October 18th 2016 and has since been updated November 8th 2022. For those seeking other similar studies, there are 2351 trials actively recruiting patients with breast cancer, as well as 1746 medical studies involving Pembrolizumab that are presently looking to enroll participants."

Answered by AI

To what extent may Pembrolizumab be hazardous to human health?

"Pembrolizumab's safety is rated 2, as the drug has already been tested and some evidence of its security exists. However, no studies have demonstrated it to be effective yet."

Answered by AI

Is access to this research currently available for participants?

"The clinical trial for which you are searching is no longer recruiting participants. It was initially posted on October 18th 2016, and the last update occurred November 8th 2022. If seeking other trials, there are over 4000 studies actively looking for patients with breast cancer or Pembrolizumab related illnesses."

Answered by AI

Can you elucidate any preceding research involving Pembrolizumab?

"Since 1997, Pembrolizumab has undergone 1329 clinical trials with City of Hope Comprehensive Cancer Center. At this current moment in time, the drug is being tried and tested on 1746 participants from various locations including Pittsburgh, Pennsylvania."

Answered by AI

What is the incidence of healthcare establishments participating in this research within city limits?

"The investigation is presently running in 5 diverse areas, including Pittsburgh, Raleigh and Greensboro. It is recommended to select the closest clinic if you are considering taking part so as to reduce transportation requirements."

Answered by AI

What end results is this clinical trial attempting to demonstrate?

"This clinical trial, with a duration of up to two years, aims to quantify the decrease in regulatory T cells (Tregs). Secondary objectives include measuring the duration of response, assessing any treatment-associated toxicity and computing the disease control rate. The best responses for each patient will be measured by RECIST v1.1 criteria which includes complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)."

Answered by AI
~5 spots leftby Apr 2025