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Anti-tumor antibiotic

Chemotherapy + Immunotherapy for Breast Cancer

Phase 1

Waitlist Available

Led By Sara Tolaney, MD MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

The participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size

Must not have

The participant has any history or evidence of active, non-infectious pneumonitis or interstitial lung disease

The participant has a medical condition that requires chronic systemic steroid therapy or any other form of immunosuppressive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well chemotherapy and immunotherapy work in treating hormone receptor positive breast cancer.

Who is the study for?

This trial is for adults with hormone receptor-positive, HER2-negative operable breast cancer larger than 2 cm without distant metastasis. They must not have had prior treatments for this cancer and agree to use contraception. Participants need normal organ/marrow function, no active autoimmune diseases or infections, and can't be on systemic steroids/immunosuppressants.

What is being tested?

The study tests chemotherapy (Nab-Paclitaxel) combined with immunotherapy (Pembrolizumab) in treating hormone receptor-positive breast cancer. It includes preoperative treatment and requires participants to undergo three research biopsies during the therapy.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions, fatigue, blood disorders, increased risk of infection and potential allergic responses to the drugs' components.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active and can carry on all pre-disease activities without restriction.

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My breast cancer is operable and my tumor is at least 2 cm big.

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I have not had radiation on the same side breast before.

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I am 18 years old or older.

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I understand the study rules and have signed the consent form.

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My breast cancer is hormone receptor-positive and HER2-negative.

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I am willing to have three research biopsies during the study.

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My breast cancer diagnosis was confirmed through tissue examination.

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

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I haven't received any treatment for my operable breast cancer.

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My organ and bone marrow functions are normal.

Exclusion Criteria

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

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I have a history of lung inflammation not caused by an infection.

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I am on long-term steroids or other drugs that weaken my immune system.

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I have an autoimmune disease that needs steroids or immunosuppressants.

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I am on IV antibiotics for an infection as of the first day.

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I have a serious illness that is not under control.

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I have previously been treated with pembrolizumab or similar therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in the Biomarker (PD-L1) Expression

Secondary study objectives

Change in Percentage of Stromal Tumor Infiltrating Lymphocytes After Monotherapy Treatment

Disease-Free Survival

Overall Response Rate

+1 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

2Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment3 Interventions

* 2 weeks Pembrolizumab Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 14 weeks

Group II: Nab-PaclitaxelExperimental Treatment3 Interventions

* 2 weeks Nab-Paclitaxel Run in * Biopsy will be performed * Post mono therapy Nab-Paclitaxel administered weekly * Post mono therapy Pembrolizumab administered every 3 weeks * Agents administered for a total of 15 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Biopsy

2014

Completed Phase 4

~1150