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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 death due to any cause, assessed up to 10 years after completion of study treatment
Awards & highlights

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.Check my eligibility
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.See study design
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
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My breast cancer has not come back in the same area after treatment.
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I have not received any live vaccines in the last 28 days.
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My heart is healthy enough for the trial, meeting the NYHA class 2B or better.
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I am not pregnant or nursing and will use effective birth control during and 6 months after the treatment.
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I haven't received any treatment for my current breast cancer.
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I am not planning to take any cancer treatments not approved by this study.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am 18 years old or older.
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My cancer has not spread to distant parts of my body.
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I have a MammaPrint Index Score of MP2 or can provide tissue for testing.
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I have a MammaPrint result.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I haven't needed steroids for lung inflammation in the last 2 years.
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I have at least 10 slides from my initial tumor biopsy for testing.
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I weigh more than 30 kilograms.
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I have inflammatory breast cancer.
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My breast cancer is hormone receptor positive and HER2 negative, as per ASCO/CAP guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast cancer event-free survival (BC-EFS)
Secondary outcome measures
Distant relapse-free survival (DRFS)
Overall survival (OS)
Pathologic complete response (pCR) rates
+1 more

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 every 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
Doxorubicin
2012
Completed Phase 3
~7940
Mammography
2015
N/A
~1450
Biospecimen Collection
2004
Completed Phase 2
~1720
Paclitaxel
2011
Completed Phase 4
~5380
Cyclophosphamide
1995
Completed Phase 3
~3770
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,955,721 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Erin F CobainPrincipal InvestigatorSWOG Cancer Research Network
~2453 spots leftby May 2026