← Back to Search

Chemotherapy

Immunotherapy + Chemotherapy for Breast Cancer (NeoPACT Trial)

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).

Must not have

Has an active infection requiring systemic therapy.

Has active autoimmune disease that has required systemic treatment in the past 2 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently being treated for an infection.

Select...

I have an autoimmune disease treated within the last 2 years.

Select...

I have been diagnosed with HIV.

Select...

I have had or currently have lung inflammation treated with steroids.

Select...

I have a history of Hepatitis B or active Hepatitis C.

Select...

I have inflammatory breast cancer.

Select...

I have not had any other cancer in the last 5 years.

Select...

My cancer has spread to other parts of my body.

Select...

I have been treated with drugs targeting immune checkpoints.

Select...

I have undergone treatment for breast cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological Complete Response (pCR) Rate

Secondary study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Pembrolizumab

2017

Completed Phase 3

~3150

Carboplatin

2014

Completed Phase 3

~6120