A randomized phase II trial of fulvestrant with or without Ribociclib after progression on aromatase inhibition plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive HER2 negative breast cancer | NYU Langone Health

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A randomized phase II trial of fulvestrant with or without Ribociclib after progression on aromatase inhibition plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive HER2 negative breast cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Metastatic Her2 Positive Breast Cancer, Metastatic Her2 Negative Breast Cancer
Age: Between 18 years - 90 years
Gender: Male or Female

Other Inclusion Criteria:

1. Patients with histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease.

2. Most recent tumor biopsy or surgical resection specimen must be either ER positive, PgR positive, or both, as defined by immunohistochemistry (IHC) =1% (as per the ASCO-CAP guidelines).

3. HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+ (i.e. indeterminate), a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. (as per the ASCO-CAP guidelines).

4. Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin. Postmenopausal status is defined by any one of the following criteria: ? Prior bilateral oophorectomy. ? Age =60 years. ? Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH, LH, and estradiol in the postmenopausal range per local normal.

You may not be eligible for this study if the following are true:

1. Prior selective estrogen receptor use, including fulvestrant.

2. Patient has a known hypersensitivity to any of the excipients of ribociclib, letrozole or fulvestrant

3. Active central nervous system (CNS) disease. History of CNS metastases or cord compression is allowable if the patient has been clinically stable for at least 4 weeks since completion of definitive treatment and is off systemic steroids.

4. Identified as having visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.