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Chemotherapy

Pembrolizumab for Breast Cancer (INTEGRAL Trial)

Phase 2
Waitlist Available
Research Sponsored by The Methodist Hospital Research Institute
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 18 weeks
Awards & highlights

INTEGRAL Trial Summary

This trial is testing a new combination cancer treatment of two drugs and a virus that helps the body fight cancer.

Eligible Conditions
  • Breast Cancer

INTEGRAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
pathological complete response (pCR) rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy
Secondary outcome measures
Number of participants with treatment-related adverse events

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

INTEGRAL Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment3 Interventions
docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,523 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,345 Total Patients Enrolled
13 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
Jenny Chang, M.D.Study ChairHouston Methodist Cancer Center
2 Previous Clinical Trials
67 Total Patients Enrolled
2 Trials studying Breast Cancer
67 Patients Enrolled for Breast Cancer

Media Library

Docetaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04095689 — Phase 2
Breast Cancer Research Study Groups: Experimental
Breast Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04095689 — Phase 2
Docetaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04095689 — Phase 2

Frequently Asked Questions

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

Are there any perilous implications associated with Pembrolizumab use?

"Our experts at Power have rated pembrolizumab's safety to be a 2 because it is only in Phase 2, meaning while there are available data concerning its security, there is no evidence of its effectiveness yet."

Answered by AI

Is enrollment in this research still available for participants?

"Per the clinicaltrials.gov website, this medical research is still accepting participants. The trial was initially published on March 17th 2021 and has since been adjusted on March 28th 2023."

Answered by AI

Could you please summarize the past research involving Pembrolizumab?

"1177 clinical trials that investigate pembrolizumab are currently underway, with 230 within the third phase. The majority of these studies take place in Chattanooga, Tennessee; however, this medication is being researched in 54172 distinct locations worldwide."

Answered by AI

What afflictions are typically remedied through Pembrolizumab?

"Pembrolizumab is often employed to combat malignant neoplasms. Additionally, this medication can be used for treating other afflictions such as unresectable melanoma, microsatellite instability high, and sarcoma."

Answered by AI

What is the current enrollment capacity of this trial?

"Affirmative, the details on clinicaltrials.gov reveals that this medical test is actively seeking potential candidates. It was first published on 17/03/2021 and most recently modified on 28/03/2023. This program will enlist 30 individuals from one centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer
Jenny C. Chang, MD 2021. "Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04095689.
~1 spots leftby Jun 2024
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