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New treatment option for Metastatic Breast Cancer
Official title Study of Palliative Radiation Combined with Pembrolizumab in Unresectable Metastatic Stage IV Breast Cancer
ClinicalTrials.gov ID: NCT04990921
What this study is testing
What is Palliative Radiation and Pembrolizumab?
Palliative Radiation and Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Also referred to as Keytruda.
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
- This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer
- Phase 2: a mid-size study of how well it works
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, women only
You may be able to join if
- 1\. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. 2\. Female age ≥ 18 years at the...
- Triple negative breast cancer patients must have received two lines of chemotherapy in the metastatic setting.
- ER+/ PR+, ER-/PR+, and ER+/PR- must have received prior Cyclin Dependent Kinase 4/6 Inhibitor in combination with Aromatase Inhibitor or fulvestrant...
- Her2 overexpressed breast cancer must have had prior trastuzumab/per (in the neoadjuvant/adjuvant or metastatic setting, and prior Ado-trastuzumab...
- Absolute neutrophil (ANC) \>1.5 x 109/L
You likely can't join if
- \> 4 Clinically active cerebral metastases. people cerebral metastases may be enrolled, provided that there are less than 4 lesions as these may...
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the...
- Any active autoimmune disease that in the judgement of the PI or sub-I could be significantly worsened by pembrolizumab
- Evidence of clinically significant immunosuppression such as the following:
- diagnosis of immunodeficiency;
- concurrent opportunistic infection;
See the full eligibility criteria
Who can join
- 1\. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. 2\. Female age ≥ 18 years at the time of informed consent. 3. Histologically confirmed diagnosis of...
- Triple negative breast cancer patients must have received two lines of chemotherapy in the metastatic setting.
- ER+/ PR+, ER-/PR+, and ER+/PR- must have received prior Cyclin Dependent Kinase 4/6 Inhibitor in combination with Aromatase Inhibitor or fulvestrant. However, ER+/Her2 overexpressed patients are not required to have...
- Her2 overexpressed breast cancer must have had prior trastuzumab/per (in the neoadjuvant/adjuvant or metastatic setting, and prior Ado-trastuzumab TDM1 therapy. 9\. Adequate organ function determined within 14 days...
- Absolute neutrophil (ANC) \>1.5 x 109/L
- Platelet count\>50 x 109/L
- Hemoglobin\>8 g/dL
- Serum creatinine \<2.0 x upper limit of normal
- Serum bilirubin \ 2.0 x ULN
- Aspartate aminotransferase (AST) \<2.5 x ULN OR \<5 x ULN for subject with liver metastases
- Alanine aminotransferase (ALT) \<2.5 x ULN OR \<5 x ULN for subject with liver metastases
- International normalization ratio (INR) or prothrombin time (PT) \<1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and partial thromboplastin time (PTT)/activated PTT (aPTT) is within...
- Lactate dehydrogenase (LDH) levels ≤ 1.5 X upper limit of normal (ULN) within 28 days prior to enrollment
- Female subject of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If the urine pregnancy test is positive or cannot be confirmed as negative, a serum...
- ECOG performance status of 0, 1 or 2.
What rules you out
- \> 4 Clinically active cerebral metastases. people cerebral metastases may be enrolled, provided that there are less than 4 lesions as these may serve as a site of pallative SBRT
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or...
- Any active autoimmune disease that in the judgement of the PI or sub-I could be significantly worsened by pembrolizumab
- Evidence of clinically significant immunosuppression such as the following:
- diagnosis of immunodeficiency;
- concurrent opportunistic infection;
- receiving systemic immunosuppressive therapy (\> 2 weeks) or within 7 days prior to the first dose of study treatment, including oral steroid doses \> 20 mg/day of prednisone or equivalent people that require...
- Subject has known sensitivity to any of the products or components to be administered during dosing
- Known human immunodeficiency virus (HIV) disease.
- Known acute or chronic hepatitis B or hepatitis C infection.
- Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. people who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus...
- Has a known history of active Bacillus tuberculosis.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Those patients who would not otherwise have an indication for palliative SBRT
- Prior therapy with tumor vaccine (unless administered in the adjuvant setting).
- Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study.
- Expected to require other cancer therapy while on study with the exception of local radiation treatment to the site of bone and other metastasis for palliative pain management. Concurrent endocrine therapy or...
- Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment or 4 months after the last dose of pembrolizumab
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment or 4 months after the last dose of pembrolizumab, whichever is later. Note: Women...
- postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone follicule stimulating hormone [FSH] level in the...
- have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR
- has a congenital or acquired condition that prevents childbearing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and...
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. 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.