Combined Immunotherapies in Metastatic ER+ Breast Cancer

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    102
  • sponsor
    Weill Medical College of Cornell University
Updated on 11 July 2021
measurable disease
growth factor
epidermal growth factor receptor
HER2
EGFR
tamoxifen
estradiol
erbb2
epidermal growth factor
palbociclib
letrozole

Summary

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.

Details
Condition Breast Cancer Diagnosis, Breast Cancer, breast carcinoma, cancer, breast
Treatment Palbociclib 125mg, Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab
Clinical Study IdentifierNCT04563507
SponsorWeill Medical College of Cornell University
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female 18 years of age pre and post-menopausal
Metastatic disease ( 5 sites of measurable disease)
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 confirmation of post-menopausal status
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/L
Platelets 100 000/L
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
mL/min for the participant with creatinine levels >1.5 institutional ULN
Hepatic Total bilirubin 1.5 ULN OR direct bilirubin ULN for participants with
total bilirubin levels >1.5 ULN
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

Exclusion Criteria

Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy
Male breast cancer patients
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 first dose of study drug
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 skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded
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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
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
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