200 Participants NeededMy employer runs this trial

Immunotherapy CARE Program for Breast Cancer

Recruiting at 7 trial locations
FG
NS
Overseen ByNeil Shah, MBBS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: PD-1 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help people with breast cancer manage their immunotherapy treatment more effectively. The researchers aim to determine if this program improves patients' management of their treatment compared to usual care. They will also assess its impact on participants' quality of life through questionnaires. Suitable candidates have breast cancer, are beginning specific immune treatments, and have essential needs such as food or transportation. Participants should reside in the New York metro area and speak English or Spanish. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative care strategies that could enhance treatment experiences for others.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Immunotherapy CARE Program is safe for participants?

Past studies on treatments using the body's immune system to fight breast cancer have shown mixed results. Some research suggests these treatments are well-tolerated. For example, one study found that a type of laser treatment was generally accepted by patients and showed promise in treating metastatic breast cancer. However, another study on Keytruda, a specific immune therapy, reported that 41% of patients experienced serious side effects, although it also helped shrink tumors.

Some of these immune-based treatments have already received FDA approval for certain types of breast cancer when combined with chemotherapy. This approval indicates a known safety record in those specific cases. As with any treatment, individual experiences can differ, so discussing options with a healthcare provider is important.12345

Why are researchers excited about this trial?

Researchers are excited about the Immunotherapy CARE Program for breast cancer because it represents a shift from traditional treatments like chemotherapy and hormone therapy. Unlike these standard options that often target cancer cells directly, this program leverages the body's own immune system to combat cancer, potentially offering more personalized and less toxic treatment. The unique focus on enhancing the immune response could lead to improved outcomes and fewer side effects, making it a promising alternative for patients seeking innovative care.

What evidence suggests that the Immunotherapy CARE Program is effective for managing breast cancer?

Research has shown that immunotherapy holds promise for treating breast cancer. In this trial, participants in the I CARE Group will receive the Immunotherapy CARE Program. Studies have found improved outcomes, particularly for patients with specific types of breast cancer. For instance, immunotherapy has led to a 5-year survival rate of over 90% and reduced the risk of recurrence by half. In patients who are PD-L1 positive, one study found that the average survival time was 25 months with immunotherapy. These findings suggest that immunotherapy could be an effective treatment option for some breast cancer patients.23678

Who Is on the Research Team?

FG

Francesca Gany, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with cancers such as kidney, bladder, breast, pancreatic, or lung cancer who are receiving immunotherapy. Participants should be able to complete questionnaires and follow the program.

Inclusion Criteria

Not pregnant and not nursing (per self-report)
At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)
Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immunotherapy treatment and participate in the navigation program

6 months
Regular visits as per treatment schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Immunotherapy CARE Program

Trial Overview

The study is testing a support program called the Immunotherapy CARE Program that helps people manage side effects and navigate resources during immunotherapy. It compares this program to usual care using quality of life surveys.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: I CARE GroupExperimental Treatment1 Intervention
Group II: U&C GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Immunotherapy in breast cancer: an overview of current ...

This review provides an overview of immunotherapies currently under clinical development and updated key results from clinical trials.

Breast Cancer - Cancer Research ...

Immunotherapy for breast cancer is developing rapidly as new studies demonstrate improved outcomes in subsets of breast cancer.

Uncovering inequalities in breast cancer immunotherapy ...

Black patients with metastatic TNBC were still 37% less likely to receive immunotherapy treatment than white patients.

Advancements in Immunotherapy for Breast Cancer - PMC - NIH

These results highlight the effectiveness of immunotherapy in a population with historically limited treatment options and poor prognosis,

Immunotherapy for Breast Cancer: Types, Success Rate, ...

5-year survival rates exceeding 90% and reduced the risk of recurrence by 50%, a 10-year overall survival rate of 84% in the HERA trial.

Preliminary safety and efficacy results of laser immunotherapy ...

The initial outcomes of this clinical trial show that LIT is well tolerated and is of great promise in the treatment of metastatic breast cancer.

Keytruda Plus Radiation Therapy Shows Promise for ...

After a median follow-up of 32 months, 41% of patients experienced severe or worse side effects. The pathologic complete response rate was 59.2% ...

Clinical Outcomes for Patients With Metastatic Breast ...

Most patients (72.1%) received IO alone and 27.9% received IO plus chemotherapy. Median progression-free survival (PFS) was 2.3 months and ...