RECRUITING

Combined Immunotherapies in Metastatic ER+ Breast Cancer

Conditions

Breast Cancer metastatic Breast cancer HR+HER2-HR + BC SBRT

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

Quick Facts

Study Start:2020-11-12

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04563507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 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/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 * 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 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

Inclusion Criteria

Exclusion Criteria

* 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 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/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
* 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 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

Contacts and Locations

Study Contact

Lhaden Tshering, B.S.

CONTACT

646-962-2196

lht4002@med.cornell.edu

Pragya Yadav, Ph.D.

CONTACT

646-962-2199

pry2003@med.cornell.edu

Principal Investigator

Silvia Formenti, M.D.

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Brooklyn Methodist Hospital - NewYork Presbyterian

New York, New York, 11215

United States

New York Presbyterian Hospital - Queens

New York, New York, 11355

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Silvia Formenti, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-12

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2020-11-12

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

metastatic Breast cancer
HR+HER2-
HR + BC
SBRT

Additional Relevant MeSH Terms

Breast Cancer