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New treatment option for Breast Cancer
Official title Combined Immunotherapies in Metastatic ER+ Breast Cancer
ClinicalTrials.gov ID: NCT04563507
What this study is testing
What is Letrozole 2.5Mg Tab?
Letrozole 2.5Mg Tab is an investigational medicine, given as a pill taken by mouth, 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
- Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90, women only
You may be able to join if
- Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine...
- Female ≥ 18 years of age pre and post-menopausal
- Metastatic disease (≤ 5 sites of measurable disease by RECIST)
- Eligible for treatment with CDK4/6 + aromatase inhibitors
- Premenopausal status is defined as either:
You likely can't join if
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy
- Any lesion \>5 cm in greatest diameter.
- Inability to obtain histologic proof of metastatic breast cancer
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: Participants...
See the full eligibility criteria
- Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) (AND/OR)...
- Female ≥ 18 years of age pre and post-menopausal
- Metastatic disease (≤ 5 sites of measurable disease by RECIST)
- Eligible for treatment with CDK4/6 + aromatase inhibitors
- Premenopausal status is defined as either:
- Patient had last menstrual period within the last 12 months, OR
- If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR
- In case of therapy-induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
- Patients who have undergone bilateral oophorectomy are eligible.
- Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Biopsy proven diagnosis of HR+HER2- metastatic breast cancer. ER expression is \>10%
- Patient needs to be able to understand and demonstrate a willingness to sign a written informed consent document
- Hematological WBC ≥ 2000/uL
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for the participant with creatinine...
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN
- Coagulation International normalized ratio (INR) OR prothrombin time (PT)
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy if PT or aPTT is within the therapeutic range of intended use of anticoagulants
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy
- Any lesion \>5 cm in greatest diameter.
- Inability to obtain histologic proof of metastatic breast cancer
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the...
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Patients with uncontrolled brain metastases
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.