Actively Recruiting
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2024-06-25
78
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of the study is to assess the safety and effectiveness of the combination of anti-PD1 immunotherapy (pembrolizumab) and radiotherapy in the preoperative treatment of HER2-negative breast cancer resistant to classical chemotherapy. The subject of the intervention will be: 1. Randomly assigned in a 2:1 ratio and double-blinded addition of pre-operative immunotherapy with pembrolizumab or placebo to standard chemotherapy 2. Addition of preoperative radiotherapy boost delivered with a CyberKnife radiosurgery system concomitantly with the use of paclitaxel (+/- carboplatin) and pembrolizumab / placebo.
CONDITIONS
Official Title
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of invasive breast cancer
- Eligible for standard preoperative chemotherapy with anthracyclines and paclitaxel
- Breast cancer stages IIA, IIB, III, or IV with limited metastases (oligometastatic disease up to 3 foci in one organ or 2 foci in two organs) suitable for radical local treatment
- Cancer without estrogen receptor expression (ER <1%) and progesterone receptor (PR <1%) or luminal cancer
- HER2-negative cancer
- Multifocal or multicentric tumors acceptable if all invasive foci are HER2-negative
- No prior chemotherapy for current breast cancer; prior hormone therapy allowed if chemotherapy is needed
- Prior anthracycline chemotherapy for any reason not allowed
- Prior oncological treatment for other cancer allowed if radical and ended at least 1 year before
- No contraindications to radiation therapy
- ECOG performance status 0 or 1
- Adequate bone marrow function and acceptable liver and kidney function
- Left ventricular ejection fraction ≥ 50%
- No contraindications to breast MRI
- For patients with reproductive potential, agreement to use adequate contraception during and for 6 months after treatment
- Giving informed written consent to participate
You will not qualify if you...
- Inflammatory breast cancer (cT4d)
- Hypersensitivity to study drugs or excipients preventing therapy start
- Major surgery or medical procedure within 14 days before study entry, except certain fertility preservation procedures
- Concurrent invasive cancer
- Known HIV, active hepatitis B or C infection
- Autoimmune diseases requiring immunosuppressive therapy (except some thyroid diseases)
- Systemic steroid therapy within 3 weeks before enrollment
- Serious uncontrolled mental illness
- Organ transplantation
- Implanted devices preventing breast MRI (unless examination possible with cardiologist's help)
- Pregnancy or breastfeeding
- Previous treatment with anti-PD-1, anti-PD-L1, or related drugs
- History of non-infectious pneumonia requiring steroids or current pneumonia
- Active infection needing systemic treatment
- Significant cardiovascular disease such as recent acute coronary syndrome
- History of active tuberculosis
- Other medical or safety conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maria Sklodowska-Curie National Research Institute of Oncology , Gliwice Branch
Gliwice, Poland
Actively Recruiting
Research Team
M
Michal Jarzab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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