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New treatment option for Breast Cancer
Official title Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
ClinicalTrials.gov ID: NCT06472583
What this study is testing
What is Keytruda?
Keytruda is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- A woman or a man over 18 years of age.
- Diagnosis of invasive breast cancer
- Patient eligible for standard preoperative chemotherapy for breast cancer with anthracyclines and paclitaxel, according to the investigator's...
- Breast cancer stage:
- any T cN1-cN3
You likely can't join if
- Inflammatory breast cancer (cT4d)
- Hypersensitivity to drugs or excipients used in the study, which, in the opinion of the researcher, does not allow therapy to be initiated
- Major surgical or medical procedure within 14 days prior to study entry; does not apply to ovariectomy performed laparoscopically, including as a...
- Parallel coexisting invasive cancer
- Co-existing known HIV (human immunodeficiency virus) infection, known active HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
- Diagnosed autoimmune disease requiring immunosuppressive therapy; does not apply to thyroid diseases if, in the opinion of the endocrinologist, they...
See the full eligibility criteria
- A woman or a man over 18 years of age.
- Diagnosis of invasive breast cancer
- Patient eligible for standard preoperative chemotherapy for breast cancer with anthracyclines and paclitaxel, according to the investigator's assessment
- Breast cancer stage:
- any T cN1-cN3
- cT4 any N (stages IIA/IIB/III/IV, excluding cT1-3 N0 patients).
- Oligometastatic disease is allowed (stage IV, up to 3 foci in one organ or 2 foci in total in 2 different organs), if radical treatment using local methods is possible, both in the treatment of the primary tumor and in...
- Cancer without estrogen receptor expression (ER\<1% and PR\<1%) or luminal cancer
- HER2-negative cancer
- Definitely multifocal or multicentric tumors are acceptable if HER2 negative status is confirmed in all identified invasive tumor foci; this is not required in the case of satellite lesions adjacent to the tumor mass or...
- No prior chemotherapy for a current diagnosis of breast cancer and no prior anthracycline chemotherapy for any reason; earlier preoperative hormone therapy is allowed if, in the investigator's opinion, the patient...
- Any oncological treatment for another cancer is acceptable if it was radical, ended at least 1 year before inclusion in the study and did not include radiotherapy in the chest area on the same side as the currently...
- There are no contraindications to radiation treatment
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) status 0 or 1
- Bone marrow function confirmed by hemoglobin concentration ≥9 g/dL and neutrophil count (ANC) ≥1500/μL and PLT (platelets) count ≥100,000/μL
- Bilirubin concentration ≤ 1.5 x upper limit of normal (ULN), except for patients with a diagnosis of Gilbert's syndrome confirmed by previous measurements or another method (then direct bilirubin ≤ ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity ≤ 3 x ULN
- Creatinine concentration ≤ ULN or creatinine clearance ≥50 mL/min according to the Cockcroft-Gault method in patients with creatinine concentration above the upper limit of normal
- Left ventricular ejection fraction EF ≥ 50%
- No contraindications to breast magnetic resonance imaging (MRI)
- In patients with reproductive potential: consent to implement adequate contraceptive methods before enrollment in the study, during therapy and for at least 6 months after the end of systemic treatment
- Giving informed written consent to participate in the study
- Inflammatory breast cancer (cT4d)
- Hypersensitivity to drugs or excipients used in the study, which, in the opinion of the researcher, does not allow therapy to be initiated
- Major surgical or medical procedure within 14 days prior to study entry; does not apply to ovariectomy performed laparoscopically, including as a risk-reducing surgical procedure and ovarian biopsy as a fertility...
- Parallel coexisting invasive cancer
- Co-existing known HIV (human immunodeficiency virus) infection, known active HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
- Diagnosed autoimmune disease requiring immunosuppressive therapy; does not apply to thyroid diseases if, in the opinion of the endocrinologist, they are not a contraindication to pembrolizumab therapy
- Any disease requiring systemic steroid therapy within 3 weeks before enrollment in the study
- Serious, uncontrolled mental illness
- Condition after organ allotransplantation
- Condition after implantation of devices that do not allow breast MRI examination (does not apply to examinations with the assistance of a cardiologist, if the patient qualifies for such a procedure);
- Pregnancy or breastfeeding
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or drugs targeting other T cell receptor inhibitors
- History of non-infectious pneumonia requiring steroid therapy or current pneumonia
- Active infection requiring systemic treatment
- Significant cardiovascular disease, such as acute coronary syndrome within the last 6 months,
- History of active tuberculosis
- Other criteria, comorbidities, conditions, therapies, laboratory abnormalities, or circumstances that, in the investigator's opinion, do not allow the study procedures to be safely performed, may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Gliwice, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gliwice, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.