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Pembrolizumab for Breast Cancer

Q: How large is the pool of potential subjects for this experiment?

That is correct. The clinical trial, which can be found on www.clinicaltrials.gov, was first posted on 1/4/2022 and updated last on 3/2/2022. The study is looking for 29 more patients from 1 location to participate in the research.

Q: Are there any more slots open for this research project?

Yes, this information is accurate. The clinical trial was posted on January 4th, 2022 and updated most recently on March 2nd, 2022.

Q: When did the FDA sanction treatment with Pembrolizumab?

Pembrolizumab's safety is estimated to be a 2. This is due to it being in Phase 2 trials, where there is data supporting its safety, but not yet efficacy.

Phase 2

Waitlist Available

Led By Jennifer Diamond, MD

Research Sponsored by University of Colorado, Denver

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 36 months

Awards & highlights

Study Summary

This trial is for patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) who will be treated with radiation to one-four sites of metastasis followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel.

Eligible Conditions

Breast Cancer
PD-L1 Mutation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1 year progression free survival rate

Secondary outcome measures

Determine clinical benefit rate (CBR)

Determine overall response rate (ORR)

Duration of response

+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: RT followed by nab-paclitaxel/paclitaxel plus pembrolizumabExperimental Treatment4 Interventions

Nab-paclitaxel/paclitaxel plus pembrolizumab will be started within 7 days of completion of RT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Paclitaxel

FDA approved

Paclitaxel

FDA approved

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,735 Previous Clinical Trials

2,149,171 Total Patients Enrolled

27 Trials studying Breast Cancer

6,513 Patients Enrolled for Breast Cancer

Cancer League of ColoradoOTHER

8 Previous Clinical Trials

231 Total Patients Enrolled

Jennifer Diamond, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

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

Would this experimental treatment be appropriate for someone of my age?

"This trial is open to patients aged 18-100. In comparison, there are 66 clinical trials for interventions targeted at children and 2369 for elderly patients."

Answered by AI

Could I potentially qualify to take part in this research?

"This study is seeking 29 participants with breast cancer between the ages of 18 and 100. The most important criteria for patients are as follows: male or female aged ≥ 18 years, HER2 negativity (defined as either in situ hybridization non-amplified [ratio of HER2 to CEP17 < 2 or single probe average HER2 gene copy number < 4 signals/cell] OR IHC 0 or 1+), ER and PR negativity (< 1% positive by IHC), treatment with < 1 prior line of systemic therapy in the metastatic setting or adjuvant/neoadjuvant setting if metastatic rec"

Answered by AI

How large is the pool of potential subjects for this experiment?

"That is correct. The clinical trial, which can be found on www.clinicaltrials.gov, was first posted on 1/4/2022 and updated last on 3/2/2022. The study is looking for 29 more patients from 1 location to participate in the research."

Answered by AI

Are there any more slots open for this research project?

"Yes, this information is accurate. The clinical trial was posted on January 4th, 2022 and updated most recently on March 2nd, 2022."

Answered by AI

When did the FDA sanction treatment with Pembrolizumab?

"Pembrolizumab's safety is estimated to be a 2. This is due to it being in Phase 2 trials, where there is data supporting its safety, but not yet efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC

2022. "Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233696.