PERSEVERE (BRE18-334)

Better treatment options for people affected by triple negative breast cancer

The goal of the PERSEVERE clinical trial is to find better treatment options for women affected by triple negative breast cancer.

Specifically, we’re investigating the use of certain medication combinations or a standard treatment approach based on:

  • Presence of cancer cell pieces, known as circulating tumor DNA (ctDNA) in your blood (liquid biopsy); and
  • Identification of genetic differences in your tumor.

Read on to learn why this study is needed, and what to expect if you volunteer to participate.

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PERSEVERE is a Phase II circulating tumor DNA enriched, genomically directed post-neoadjuvant trial for patients with residual triple negative breast cancer.

Why is this study being done?

Recent research shows that patients who test positive for circulating tumor DNA (ctDNA), or tumor cell pieces found in the bloodstream, after surgery are at higher risk of their cancer returning in the future.

For patients who test positive for ctDNA, the study will look more closely at the DNA of their blood and tumor to see if there are any genetic differences that can be treated with a targeted genomic therapy or standard of care.

Patients who test negative for ctDNA will receive a standard treatment based on discussion with their physician.

What is genomic therapy?

Traditional chemotherapy targets all dividing cells, causing cell death to even non-cancerous cells. Drugs labeled as targeted therapies interfere with specific proteins or molecules that are required for continued growth and function of tumor cells.

The goals of targeted therapy are to deliver a more direct treatment to kill the tumor cells while saving healthy cells, which reduces side effects.

Who is eligible for this study?

Patients with residual triple negative breast cancer, or cancer tissue remaining despite having had chemotherapy before surgery, are invited to participate. There are additional specific criteria which your study team will review to confirm that you are eligible for this study.

What will happen if I decide to take part in this study?

If you decide to take part in this study, you will have blood drawn to see if you have cancer cell pieces, ctDNA, in your blood (ctDNA positive or negative).

In addition, an archived (stored) tumor sample from your previous surgery will be collected to perform “next generation sequencing” testing to look at abnormalities and differences in the DNA/RNA (building blocks of cells). The results of these tests may take up to three weeks.

What are the study groups?

This study has three study groups, called arms. You will be assigned to a group based on the results of your ctDNA test and your genomic sequencing results.

After you finish your study treatment, your doctor will continue to follow you for up to five years. This will include checking with you for side effects and signs of cancer recurrence.

Arm 3

Patients in this group do not have ctDNA in their blood.

If you are in this group, you will get the standard of care treatment, capecitabine, or another treatment that you and your physician think is best for you, including the option of no treatment/observation. There will be about 62 people in this group.

We want all patients diagnosed with triple negative breast cancer to be survivors.

Questions?

If you have questions or need more information about participating in the PERSEVERE study, contact Casey Bales at calallen@iu.edu.

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