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CFI-400945 + Durvalumab for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

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

Must have

Only female patients will be enrolled

Patients must be ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effect of two drugs, CFI-400945 and durvalumab, on breast cancer.

Who is the study for?

This trial is for women with advanced or unresectable triple negative breast cancer, which means their tumors lack receptors for estrogen, progesterone, and HER2. Participants need to have a specific tissue block available and must be able to provide consent. They should have documented disease progression and be over 18 years old with good performance status (able to carry out daily activities).

What is being tested?

The study is testing the effects of two drugs on breast cancer: CFI-400945, an experimental drug, and Durvalumab, an immunotherapy drug. The goal is to see how these treatments impact the progression of advanced triple negative breast cancer.

What are the potential side effects?

Potential side effects from CFI-400945 could include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Durvalumab may cause immune-related reactions affecting organs like lungs or intestines; skin rash; infusion-related symptoms; hormone gland issues.

Eligibility Criteria

Inclusion Criteria

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

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I am a female patient.

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I am 18 years old or older.

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I am fully active or have some restrictions but can still take care of myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate

Secondary study objectives

Disease Control Rate

Immune-Related Response Rate (iRECIST) of CFI-400945 Given With Durvalumab

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471

26%

Asthenia

20%

Anaemia

20%

Constipation

17%

Decreased appetite

16%

Diarrhoea

15%

Nausea

13%

Pruritus

10%

Urinary tract infection

10%

Cough

10%

Fatigue

Vomiting

Dyspnoea

Back pain

Oedema peripheral

Pyrexia

Arthralgia

Hypothyroidism

Haematuria

Abdominal pain

Blood creatinine increased

Weight decreased

Sepsis

Tumour hyperprogression

General physical health deterioration

Pneumonia

Death

Acute kidney injury

Pyelonephritis

Device related infection

Urosepsis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab

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: CFI-400945 + DurvalumabExperimental Treatment2 Interventions

CFI-400945 32 mg orally on Days 1-7 and Days 15-21 of Cycle 1 (28 day cycle) and then daily from Cycle 2 on and Durvalumab 1500mg IV on Day 1 (28 day cycles) from Cycle 2 on.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CFI-400945

2014

Completed Phase 1

~50

Durvalumab

2017

Completed Phase 2

~3750