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Pre-op Pembro + Radiation Therapy for Breast Cancer
Study Summary
This trial is studying how well a combination of neoadjuvant radiation therapy, immunotherapy, and chemotherapy works in treating patients with lymph node-positive, triple-negative, or hormone receptor-positive/HER2-negative breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I am planned to receive specific chemotherapy before surgery.I have had radiation therapy on the same side of my chest before.I plan to have breast surgery with or without reconstruction after chemotherapy.My cancer is present in multiple locations within the same organ.I am fully active or can carry out light work.I have not received a live vaccine in the last 30 days.I cannot undergo radiation therapy due to health reasons.My breast cancer is early stage but high risk, and either triple negative or HR+/HER2-.I have had breast cancer or another cancer that is getting worse or needed treatment in the last 5 years.My organs are functioning well.I have an active Hepatitis B or C infection.I am willing to have a breast tumor biopsy between weeks 2-3 of Cycle 1.My treatment plan meets the study's radiation dose requirements.I have cancer in both breasts at the same time.My breast tumor is larger than 1.5 cm.I am not pregnant, not breastfeeding, and meet one of the required conditions.I have had cancer treatment or been in a trial within the last 4 weeks.I have had or currently have lung inflammation treated with steroids.I cannot have surgery to remove my breast cancer.I have an active tuberculosis infection.I have markers placed in my breast tumor and lymph node.I am 18 years old or older.I am not currently using immunosuppressants or systemic corticosteroids.I am not pregnant as confirmed by a test within 72 hours before starting the study treatment.I have been diagnosed with HIV.My breast cancer was confirmed with a biopsy and has spread to my lymph nodes.I agree to follow the contraception guidelines and not donate sperm for 4 months after my last treatment dose.I have received an organ or tissue transplant from another person.My breast cancer has spread to other parts of my body.My cancer has not spread to distant parts of my body.You have an autoimmune disease that is currently active or you have a suspicion of having an autoimmune disease.My breast cancer is inflammatory.My breast cancer is HER2-positive according to specific guidelines.I have been treated with specific immune therapy drugs before.
- Group 1: Group C (High Dose RT Boost)
- Group 2: Group A (No RT Boost)
- Group 3: Group B (Low Dose RT Boost)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has a study like this been attempted before?
"Pembrolizumab, a medication with a long research history dating back to 1997, has been the focus of 3153 active clinical trials in 87 different countries."
What are the primary cancers that Pembrolizumab is used to target?
"Pembrolizumab is frequently used to treat melanoma; however, it can also be prescribed for neoplasm metastasis, malignant melanoma of skin, and kaposi's sarcoma aids related."
Is this clinical trial being run by many hospitals in North America?
"To make participation as easy as possible for patients, the 9 clinical trial sites are located in major cities including Rochester, Chapel Hill and Bronx. Additionally, there are 6 other locations recruiting for this study."
Are there any dangers that come with Pembrolizumab?
"While there is some evidence to support Pembrolizumab's safety, it is still in Phase 2 of clinical trials and has not been proven effective."
How many people total are being monitored in this research?
"In order to collect the desired data, this clinical trial requires 120 willing and eligible participants. Those who wish to take part in the study can do so at Mayo Clinic - Rochester located in Rochester, Minnesota or University of North carolina Medical Center situated in Chapel Hill, North Carolina."
Are there Pembrolizumab clinical trials in other countries?
"Pembrolizumab was first studied in 1997 at Spectrum Health's Butterworth Campus. So far, there have been 3459 completed clinical trials and currently there are 3153 live trials. A large number of these ongoing studies are based out of Rochester, Minnesota."
Are we still able to sign up for this opportunity?
"That is accurate. According to the information on clinicaltrials.gov, this trial was initially posted on December 16th 2020 and updated February 7th 2022. The study is looking for 120 individuals total between 9 different locations."
What are the specific goals that this medical study is hoping to achieve?
"The primary objective of this study, which will be measured over a 14 to 21 day period, is the rate of pathologic response in lymph nodes. In addition to the primary outcome, this trial will also evaluate secondary outcomes including change in symptoms and satisfaction with treatment. These measures will include the Breast-Q, four domains that will be evaluated before and after surgery: satisfaction with breasts, psychosocial well-being, sexual well-being, and physical well-being. Scores for each domain range from 0 to 100, with higher scores indicative of better quality of life. The trial will also measure residual cancer burden (RCB"
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