CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

STATUS

Recruiting
End date

Dec 31, 2028
participants needed

204
sponsor

Weill Medical College of Cornell University

Send

Updated on 19 February 2024

See if I qualify

epidermal growth factor receptor

direct bilirubin

neutrophil count

growth factor

anticoagulants

tamoxifen

oophorectomy

international normalized ratio

palbociclib

letrozole

anticoagulant therapy

menstrual period

estradiol

epidermal growth factor

aptt

conjugated bilirubin

stage iv breast cancer

toremifene

stereotactic body radiation therapy

er+ breast cancer

HER2

oestrogen receptor positive breast cancer

plasma oestradiol

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, Breast Cancer
Age	18years - 90years
Treatment	Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
Clinical Study Identifier	NCT04220476
Sponsor	Weill Medical College of Cornell University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Female 18 years of age pre and post-menopausal
	Oligometastatic disease ( 5 sites of disease)
	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 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 30 mL/min for 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 participant is receiving anticoagulant therapy if PT or aPTT is within 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 received previous endocrine or chemotherapy for 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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epidermal growth factor receptor

international normalized ratio

palbociclib

letrozole

anticoagulant therapy

menstrual period

estradiol

epidermal growth factor

aptt

conjugated bilirubin

stage iv breast cancer

toremifene

stereotactic body radiation therapy

er+ breast cancer

HER2

oestrogen receptor positive breast cancer

plasma oestradiol

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CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer