Clinical Trial Seeks Participants With Triple-Negative Breast Cancer That Remains After Pre-Surgery Chemotherapy

This phase III clinical trial will look at the immunotherapy pembrolizumab
Featured Clinical Trials
May 15, 2019
By: 
Madison Hughes, Content Coordinator
Reviewed By: 
Romualdo Barroso-Sousa, MD, PhD

In early-stageinfo-icon triple-negative breast cancer it’s not clear whether giving further systemicinfo-icon, or full-body, treatment after neoadjuvant chemotherapy helps better treat the disease. Neoadjuvant chemotherapyinfo-icon is chemotherapy given before surgery to shrink the tumorinfo-icon and make it easier to remove, or to help doctors predict how the cancer will respond to future treatments. Systemic treatment includes anticancer medicines like chemotherapy and immunotherapy.

The SWOG S1418/NRG-BR006 trial seeks 1,000 women and men across the country to look at whether the immunotherapyinfo-icon pembrolizumab (Keytruda) can better treat early-stage, triple-negative breast cancerinfo-icon that remains in the breast, lymphinfo-icon nodes or both after neoadjuvant chemotherapy.

Background

Pembrolizumab is a type of immunotherapy called a monoclonal antibodyinfo-icon. It targets a proteininfo-icon present on the surface of certain white blood cells, including cells called T lymphocytes or “T cells.” This protein, called PD-1, helps regulate the immune systeminfo-icon. Pembrolizumab works on the T cells by blocking the work of the PD-1 receptors, releasing the brakes from the immune system to kill cancer.

Pembrolizumab is already FDAinfo-icon approved to treat any cancer with certain mutations, and also for several types of cancer other than breast cancer. These approvals include stage III melanoma treated with surgeryinfo-icon or stage IV (metastaticinfo-icon) cancers. But recent early clinicalinfo-icon trials suggest pembrolizumab may help treat early-stage triple-negative breast cancers. Researchers hope immunotherapy can be used to get rid of cancer that remains despite neoadjuvant treatment, protecting people from a recurrenceinfo-icon of breast cancer later.

Goals

The SWOG S1418/NRG-BR006 trial is looking at whether giving pembrolizumab to people with early-stage, triple-negative breast cancer effectively treats the cancer. The main goal is to track what researchers call invasive disease-free survival, or how long it takes participants from the start of the trial to have a return of breast cancer or a new cancer of any kind.

Researchers also will look at fatigueinfo-icon, side effects, and quality of lifeinfo-icon, the impact of the treatment on day-to-day life.

A secondary goal is to compare the groups for overall survival, or how long people live after entering the study.

Design

This study is a phase III, open label trial. Open label means participants and their doctors know which treatment has been assigned.

All participants will have finished neaoadjuvant chemotherapy and had breast cancer cells remaining at the time of surgery. At that surgery, at least 1 centimeter of cancer must have been found in either the breast or the nearby lymph nodes under the arm.

Participants may have had extra (adjuvant) chemotherapy after surgery for up to 24 weeks and still enroll in the study. During the trial they may have radiation therapyinfo-icon, if their doctor recommends it.

Participants will be assigned to one of two groups:

  • Arm I participants do not receive pembrolizumab. They receive standard follow-up care for breast cancer, seeing their doctor every 12 weeks for 1 year, then every 6 months for 4 years and annually for 5 years.
  • Arm II participants receive pembrolizumab by veininfo-icon (intravenously or by IV) for 30 minutes on days 1 and 22 of a 42-day cycle. The treatment will repeat for 52 weeks, unless the cancer grows or they have to stop because of side effects.

All participants will be followed for up to 10 years.

Eligibility

This study is accepting women and men with up to stage IIIc triple-negative breast cancer who finished their primary treatmentinfo-icon and have at least 1 centimeter of cancer left in the breast and/or positive lymph nodes. If you want to participate, your treatment must have included standard chemotherapy for 16 to 24 weeks for triple-negative breast cancer, given before surgery. You cannot

  • have had immunotherapy before
  • receive other immunotherapy during the study for any conditioninfo-icon
  • receive any other anti-cancer treatment (besides radiation therapy) during the study

You may not be able to participate if you have

  • difficulties taking care of yourself and spend most of your time in bed
  • an active infectioninfo-icon
  • an active autoimmune disease that requires full-body therapyinfo-icon, like lupus, in the past 2 years
  • a history of or active inflammationinfo-icon of the lung tissueinfo-icon, called pneumonitis, that is not caused by infections
  • received a live vaccine, like the shingles vaccine, less than 30 days before starting the trial
  • have had some past forms of invasive cancerinfo-icon
  • hepatitis B or hepatitis C that’s currently causing symptoms

This trial accepts some people with HIV. If you are HIV-positive and want to participate, ask your doctor to see if you qualify.

If you are interested, talk to your doctor about whether this trial is a good fit for you. A trial coordinator can also speak with you about your ability to participate.

SWOG S1418/NRG-BR006 is being held at more than 600 locations throughout the United States. Visit CancerTrials.gov for a full list of locations or ask your doctor if your cancer center is participating.

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Additional Related Topics 
Triple-Negative
Immunotherapy