PERSEVERE (BRE18-334)

Why is this study being done?

We hope to find better treatment options for people affected by triple negative breast cancer. The purpose of this study is to investigate using certain medication combinations or a standard treatment approach based on (1) presence of cancer cell pieces, known as circulating tumor DNA (ctDNA) in your blood (liquid biopsy) and (2) identification of genetic differences in your tumor. 

Recent research shows that patients who test positive for circulating tumor DNA (ctDNA), or tumor cell pieces found into the blood stream, after surgery are at higher risk of their cancer returning in the future. For patients that test positive for ctDNA, the study will look closer 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.  For patients that test negative for ctDNA, they 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?

Patient’s with residual triple negative breast cancer, 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.

Based on these test results and completion of other eligibility requirements, you will be assigned to one of 3 treatment groups.

  • For Arm 1 you will receive up to eight cycles of genomically directed treatment in addition to the standard of care therapy (capecitabine) with each cycle lasting 21 days. About 30 days after your last dose of medication, you will have a safety follow up visit to see how you are doing.
  • For Arm 2 your physician will treat you according to standard therapies. You will be asked to return six months after you join the study for another blood draw.
  • For Arm 3 your physician will treat you according to standard therapies or no therapy. You will be asked to return six months after you join the study for another blood draw.

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

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.

Schema for clinical trial-PERSEVERE
  • Arm 1: Patients in this group have ctDNA in their blood and have a genomic target found in their cancer tissue. If you are in this group, you will receive genomically directed treatment in combination with a standard of care medication, Capecitabine. You will be assigned to one of four groups based on the results of genomic sequencing of your cancer tissue. There will be 90 people in this group.
    • Arm 1a: Patients assigned to this group will receive Talazoparib and Capecitabine
    • Arm1b: patients assigned to this group will receive Atezolizumab and Capecitabine
    • Arm 1c: Patients assigned to this group will receive Inavolisib and Capecitabine
    • Arm 1d: Patients assigned to this group will receive Talazoparib, Atezolizumab, and Capecitabine.
  • Arm 2: Patients in this group have ctDNA in their blood but did not have a genomic target found in their blood or cancer tissue. 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. There will be about 25 people in this group.
  • 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.