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Chemotherapy

Immunotherapy + Chemotherapy for Breast Cancer (NeoPACT Trial)

Q: What conditions commonly necessitate a prescription of Pembrolizumab?

<p>Pembrolizumab is generally utilized to treat head <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, but can also be advantageous in the management of <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, metastatic urothelial carcinoma and non-Hodgkin's <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>.</p>

Phase 2

Waitlist Available

Led By Priyanka Sharma, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histologically confirmed stage I, II or III TNBC (triple-negative breast cancer).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

NeoPACT Trial Summary

This trial will test the effectiveness of adding the immunotherapy drug Pembrolizumab to the standard chemotherapy treatment for women with early-stage, aggressive triple-negative breast cancer.

Who is the study for?

This trial is for women with stage I-III triple-negative breast cancer who haven't had previous breast surgery, chemotherapy, or radiation for their cancer. They must have good heart and organ function, not be pregnant or breastfeeding, and if of childbearing potential, agree to follow contraceptive guidelines.Check my eligibility

What is being tested?

The study tests Pembrolizumab (an immunotherapy) combined with Carboplatin and Docetaxel (chemotherapy drugs), given before surgery to see if it improves outcomes in TNBC patients. Pegfilgrastim is also used to support immune cell growth after chemo.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells, infusion-related reactions from the drug entering the body, fatigue, nausea from chemotherapy drugs, low blood counts leading to increased infection risk.

NeoPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My breast cancer is confirmed as stage I, II, or III and is triple-negative.

Select...

I haven't had chemotherapy, hormone therapy, or radiation for this cancer.

Select...

I haven't had breast surgery on the same side as my current breast cancer.

Select...

I am not able to become pregnant.

NeoPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Pathological Complete Response (pCR) Rate

Secondary outcome measures

Minimal Residual Disease (MRD) Rate

Percentage of Participants With Event-free Survival (EFS) as Assessed by Kaplan-Meier Method

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

NeoPACT Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Carboplatin & Docetaxel plus PembroluzimabExperimental Treatment4 Interventions

Carboplatin (Area under the curve [AUC] 6 intravenously [IV]) and Docetaxel (75 milligrams per meter squared [mg/m2], IV) plus Pembrolizumab (200 milligrams [mg], IV) every 21 days for 6 cycles. Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4410

Carboplatin

2014

Completed Phase 3

~6670

Docetaxel

1995

Completed Phase 4

~5620

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,037 Total Patients Enrolled

23 Trials studying Breast Cancer

4,510 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,854 Total Patients Enrolled

59 Trials studying Breast Cancer

7,534 Patients Enrolled for Breast Cancer

Priyanka Sharma, MDPrincipal InvestigatorThe University of Kansas Cancer Center

7 Previous Clinical Trials

1,746 Total Patients Enrolled

5 Trials studying Breast Cancer

1,612 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03639948 — Phase 2

Breast Cancer Research Study Groups: Experimental: Carboplatin & Docetaxel plus Pembroluzimab

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03639948 — Phase 2

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03639948 — Phase 2

Frequently Asked Questions

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

What conditions commonly necessitate a prescription of Pembrolizumab?

"Pembrolizumab is generally utilized to treat head cancer, but can also be advantageous in the management of melanoma, metastatic urothelial carcinoma and non-Hodgkin's lymphoma."

Answered by AI

What other research has been done in regard to the efficacy of Pembrolizumab?

"Currently, 1819 clinical studies concerning pembrolizumab are still in progress with 413 of those trials being categorized as Phase 3. While a majority of these investigations on the drug originate from Shanghai, there are 88746 sites conducting research into it world wide."

Answered by AI

Is Pembrolizumab known to have any deleterious effects on humans?

"Power's assessment of Pembrolizumab's safety is a 2 on the scale, as Phase 2 trials have only provided limited data regarding its security. No efficacy studies have been conducted at this time."

Answered by AI

What is the aggregate participation rate for this experiment?

"At present, this clinical trial is not accepting participants. It was first posted on September 4th 2018 and last updated on June 6th 2022. If you are looking for other opportunities to participate in medical research, there are 2346 studies with breast cancer patients and 1819 trials involving Pembrolizumab currently enrolling volunteers."

Answered by AI

Am I able to become a participant in this research endeavor?

"Successful candidates to this clinical trial must have been diagnosed with breast cancer, and be between 18-70 years of age. A total of 121 participants are needed for the study."

Answered by AI

Does the study cohort include participants of advanced age?

"To qualify for this clinical trial, participants must be over 18 years and under 70."

Answered by AI

How many hospitals in North America are administering this trial?

"As of now, 9 clinical trial sites are recruiting subjects. These locations span from Dallas to Overland Park and Lee's Summit, among other cities. If you decide to take part in the study, it is highly recommended that you choose a site closeby so as to minimize your travel burden."

Answered by AI

Are there any available opportunities for participation in this research?

"According to the clinicaltrials.gov database, this trial concluded recruitment on June 6th 2022 and is no longer actively searching for patients. Despite that, there are still 4165 other trials recruiting at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer

2018. "Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03639948.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer