← Back to Search

Chemotherapy

Durvalumab + Chemotherapy for Breast Cancer

Phase 3

Recruiting

Led By Erin F Cobain

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must not have locally recurrent breast cancer

Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from date of randomization (2nd registration) to date of invasive distant disease recurrence or death due to any cause, assessed up to 10 years after completion of study treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effects of adding an immunotherapy drug (durvalumab) to usual chemotherapy to usual chemotherapy alone in treating breast cancer.

Who is the study for?

This trial is for adults with stage II-III hormone receptor positive, HER2 negative breast cancer who have not had prior treatment. They must be in good physical condition (Zubrod Performance Status of 0-2), have no metastatic disease, and cannot be pregnant or breastfeeding. Participants need to agree to use effective contraception and should not have a history of certain conditions like uncontrolled diabetes, active pneumonitis, or autoimmune diseases requiring recent systemic treatment.

What is being tested?

The study tests if adding Durvalumab (an immunotherapy drug) to standard chemotherapy (Paclitaxel, Cyclophosphamide, Doxorubicin) improves outcomes for patients with specific high-risk breast cancer as identified by MammaPrint testing. It's a phase III trial where participants are randomly assigned to receive either the new combination therapy or just the usual chemotherapy.

What are the potential side effects?

Durvalumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues, fatigue, infusion reactions similar to allergic responses and potential worsening of pre-existing autoimmune diseases. Standard chemotherapy can cause hair loss, nausea/vomiting, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

Select...

My breast cancer has not come back in the same area after treatment.

Select...

I have not received any live vaccines in the last 28 days.

Select...

My heart is healthy enough for the trial, meeting the NYHA class 2B or better.

Select...

I am not pregnant or nursing and will use effective birth control during and 6 months after the treatment.

Select...

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

Select...

I am not planning to take any cancer treatments not approved by this study.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Select...

I am 18 years old or older.

Select...

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

Select...

I have a MammaPrint Index Score of MP2 or can provide tissue for testing.

Select...

I have a MammaPrint result.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Select...

I haven't needed steroids for lung inflammation in the last 2 years.

Select...

I have at least 10 slides from my initial tumor biopsy for testing.

Select...

I weigh more than 30 kilograms.

Select...

I have inflammatory breast cancer.

Select...

My breast cancer is hormone receptor positive and HER2 negative, as per ASCO/CAP guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from date of randomization (2nd registration) to date of death due to any cause, assessed up to 10 years after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from date of randomization (2nd registration) to date of death due to any cause, assessed up to 10 years after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from date of randomization (2nd registration) to date of death due to any cause, assessed up to 10 years after completion of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Breast cancer event-free survival (BC-EFS)

Secondary study objectives

Distant relapse-free survival (DRFS)

Overall survival (OS)

Pathologic complete response (pCR) rates

+1 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Step 2, Arm 2 (chemotherapy, durvalumab)Experimental Treatment7 Interventions

Patients receive paclitaxel IV over 30-60 minutes on days 1 and 8 of each cycle and durvalumab IV over 60 minutes on day 1 of every other cycle. Treatment repeats every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 of each cycle, and durvalumab IV over 60 minutes on day 1 of every other cycle. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mammography during screening (STEP 1). Patients have the option to also undergo collection of tumor tissue during initial biopsy (STEP 1) and at SOC surgery, and undergo collection of blood samples prior to STEP 2 treatment, after cycle one of chemotherapy, and one month post-SOC surgery.

Group II: Step 1 (MammaPrint testing)Experimental Treatment1 Intervention

Patients without a known MP2 score undergo MammaPrint testing on a previously-collected tissue sample. Patients with MP2 score proceed to STEP 2.

Group III: Step 2, Arm 1 (chemotherapy)Active Control6 Interventions

Patients receive paclitaxel IV over 30-60 minutes on days 1 and 8 of each cycle. Treatment repeats every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mammography during screening (STEP 1). Patients have the option to also undergo collection of tumor tissue during initial biopsy (STEP 1) and at SOC surgery, and undergo collection of blood samples prior to STEP 2 treatment, after cycle one of chemotherapy, and one month post-SOC surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mammography

2015

N/A

~1450

Doxorubicin

2012

Completed Phase 3

~8030