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PARP Inhibitor

Olaparib + Pembrolizumab for Breast Cancer

Phase 2

Recruiting

Led By Ayca Gucalp, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Newly diagnosed histologically confirmed Stage T1c-3N0-3 TNBC (ER/PgR negativity will be defined using IHC per ASCO/CAP criteria/HER2-negativity will be defined using ISH or IHC assays per ASCO/CAP criteria) OR Hormone receptor-positive, HER2-negative breast cancer defined as per ASCO/CAP criteria

All patients must have a germline mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D

Must not have

A WOCBP who has a positive urine pregnancy test within 72 hours prior to study start

Stage IV (metastatic) breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the efficacy of combining two drugs, pembrolizumab and olaparib, given before surgery, to treat TNBC or HR+ HER2- breast cancers. The study drugs could potentially shrink the cancer, but they may also cause side effects. The goal of the trial is to see if the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.

Who is the study for?

This trial is for adults with newly diagnosed Stage T1c-3N0-3 Triple Negative Breast Cancer or Hormone Receptor-positive HER2-negative breast cancer, who have a certain gene mutation (BRCA1/2, PALB2, RAD51C/D). They must be able to undergo surgery after treatment and agree to use contraception. Exclusions include prior cancer treatments within 4 weeks, severe allergies to the drugs being tested, active infections or pneumonitis, certain heart conditions, and pregnancy.

What is being tested?

The study tests combining Olaparib and Pembrolizumab before surgery in patients with specific types of breast cancer. The goal is to see if these drugs can shrink tumors more effectively than current standards. Participants will receive both medications and their tumor size will be measured for comparison.

What are the potential side effects?

Possible side effects from Olaparib may include nausea, fatigue, blood cell count changes leading to infection risk or anemia; while Pembrolizumab could cause immune system-related issues like inflammation in organs or skin problems. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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

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I have a genetic mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

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I agree to have surgery, including lymph node removal and breast removal if needed, after initial treatment.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I am a woman of childbearing potential and my recent pregnancy test was positive.

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

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

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I have been diagnosed with HIV.

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I haven't had any severe infections or been hospitalized for infection complications in the last 4 weeks.

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I have had breast cancer before.

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I have an autoimmune disease treated with medication in the last 2 years.

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

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I have an active TB infection.

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I have been treated with drugs targeting immune checkpoints.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have another cancer that has gotten worse or needed treatment in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

pathologically negative MRI-guided biopsy

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

1Treatment groups

Experimental Treatment

Group I: Olaparib in Combination with PembrolizumabExperimental Treatment2 Interventions

Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks in conjunction with olaparib (for the first 12 weeks) and cytotoxic chemotherapy (after olaparib has been completed) if administered prior to surgery and if the patient is not deemed to have tumor growth.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Pembrolizumab

2017

Completed Phase 3

~3130