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Chemotherapy

Pre-op Pembro + Radiation Therapy for Breast Cancer

Phase 2

Recruiting

Led By Alice Y Ho, MD, MBA

Research Sponsored by Laura M. Spring, MD

Eligibility Criteria Checklist

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

Must have

Neoadjuvant chemotherapy (NAC) with paclitaxel, dose-dense doxorubicin and cyclophosphamide (dd AC) is planned

ECOG performance status score of 0 or 1

Must not have

Prior ipsilateral breast, chest wall or thoracic radiotherapy

Contraindication to radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well a combination of neoadjuvant radiation therapy, immunotherapy, and chemotherapy works in treating patients with lymph node-positive, triple-negative, or hormone receptor-positive/HER2-negative breast cancer.

Who is the study for?

This trial is for adults with lymph node-positive, non-metastatic breast cancer that's either triple negative or high-risk HR+/HER2-negative. Participants must have a primary tumor ≥1.5 cm, good organ function, and an ECOG score of 0 or 1. They should plan to have surgery after chemotherapy and be willing to use contraception.

What is being tested?

The study tests combining neoadjuvant radiotherapy with immunotherapy (Pembrolizumab) and various chemotherapies (Paclitaxel, Doxorubicin, Cyclophosphamide; Carboplatin and Capecitabine are optional for TN). It aims to evaluate the effectiveness of this treatment regimen before surgery.

What are the potential side effects?

Possible side effects include allergic reactions to Pembrolizumab or chemo drugs, inflammation from radiation therapy, fatigue from any treatment component, potential blood disorders from chemotherapy agents like Doxorubicin or Paclitaxel.

Eligibility Criteria

Inclusion Criteria

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

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I am planned to receive specific chemotherapy before surgery.

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I am fully active or can carry out light work.

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My breast cancer is early stage but high risk, and either triple negative or HR+/HER2-.

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My breast tumor is larger than 1.5 cm.

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I have markers placed in my breast tumor and lymph node.

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I am 18 years old or older.

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My breast cancer was confirmed with a biopsy and has spread to my lymph nodes.

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My cancer has not spread to distant parts of my body.

Exclusion Criteria

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

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I have had radiation therapy on the same side of my chest before.

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I cannot undergo radiation therapy due to health reasons.

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I have had breast cancer or another cancer that is getting worse or needed treatment in the last 5 years.

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I have an active Hepatitis B or C infection.

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

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I cannot have surgery to remove my breast cancer.

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I have an active tuberculosis infection.

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I am not currently using immunosuppressants or systemic corticosteroids.

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I have been diagnosed with HIV.

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I have received an organ or tissue transplant from another person.

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My breast cancer has spread to other parts of my body.

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My breast cancer is inflammatory.

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My breast cancer is HER2-positive according to specific guidelines.

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I have been treated with specific immune therapy drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Rate of pathologic response in the lymph node

Tumor Infiltrating Lymphocytes (TILs; CD3+/CD8+ T-cell Breast Immunoscore)

Secondary study objectives

Change Patient Reported Outcomes

Change in Symptoms and Satisfaction with Treatment

Change in TIL counts by H&E in pre-treatment versus post-RT boost tumor biopsy

+13 more

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

Systemic infection

Clostridium difficile colitis

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

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C (High Dose RT Boost)Experimental Treatment7 Interventions

High-dose RT boost plus pembrolizumab followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy. There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Group II: Group B (Low Dose RT Boost)Experimental Treatment7 Interventions

Low-dose RT boost plus pembrolizumab, followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy. There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Group III: Group A (No RT Boost)Experimental Treatment6 Interventions

No RT boost plus pembrolizumab, followed by pembrolizumab plus paclitaxel, doxorubicin and cyclophosphamide chemotherapy.There will be up to a total of 8 cycles of pembrolizumab (4 cycle before surgery and 4 cycles after surgery at the discretion of the study doctor).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

Carboplatin

2014

Completed Phase 3

~6120