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Protocol No. UW16088

Principal Investigator ORegan, Ruth

Phase II

Age Group Adult

Scope National

Sponsor Type Institutional

Title A randoMized phAse II trIal of fulvestraNt wiTh or without Ribociclib After progression on AntI-estrogeN therapy plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer (MAINTAIN Trial)

Objective The purpose of this study is to determine whether there is clinical benefit to continue therapy beyond progression for metastatic or unresectable breast cancer and to evaluate the effectiveness of continuing therapy with a CDK4/6 inhibitor such as ribociclib. Given the significant benefit seen with these medications, it is very important to determine the maximal benefit that can be received.

Treatment The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called "Cyclin Dependent Kinase 4 and 6 inhibitors," which are also referred to as CDK4/6 inhibitors" for short. A different medication within this same family of medications, named palbociclib, was approved by the FDA in February 2015 to treat patients like you who have metastatic or unresectable breast cancer that is sensitive to hormones and which is not sensitive to the effects of the the HER2 protein.

Description If you are being enrolled in this study and have never previously received a CDK4/6 inhibitor as part of treatment for metastatic or unresectable breast cancer, then you will be provided with ribociclib in combination with an aromatase inhibitor (letrozole) during this study. If there is evidence that the cancer has begun to grow while taking a CDK4/6 inhibitor, you will be randomly assigned to join one of two study groups. Randomization is like flipping a coin. Both of these study groups will receive fulvesdtrant (also known as faslodex), a hormone therapy that is given by injection. In the first group, in addition to fulvestrant, you will continue taking a CDK4/6 inhibitor (namely ribociclib). In the second group, in addition to fulvestrant, you will be receiving a placebo. If you are being randomized after already receiving CDK4/6 inhibitor plus an aromatase inhibitor, you will be randomly assigned to one of the two study arms: Fulvestrant and continuation with a CDK4/6 inhibitor, ribociclib, or Fulvestrant and placebo. Because the study is blinded, neither you nor your doctor will know which of the two groups you are in until after the study is completed.

Key Eligibility
  • Men or women at least 18 years of age with histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease
  • Most recent tumor biopsy or surgical resection specimen must be either ER positive, PgR positive, or both HER2-negative breast cancer
  • Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin
  • Patients are ineligible if prior selective estrogen receptor downregulator use (SERD), including fulvestrant
  • Patients are ineligible if they have ctive central nervous system (CNS) disease
  • Patients are ineligible if they identified as having visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Patients are ineligible if they received more than 1 prior systemic chemotherapy in the unresectable or metastatic setting. If the patient received 1 prior systemic chemotherapy, the patient is eligible. Having received prior targeted therapies for breast cancer (such as everolimus or experimental agents) does not affect eligibility for this study
  • Patient is ineligible if they have a known history of HIV infection (testing not mandatory)
  • Patient is ineligible if pregnant or nursing
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 21 days after completion of study medication

Applicable Disease Sites Breast

Therapies Involved Hormone Therapy; Other

Drugs Involved Faslodex (fulvestrant); LEE011 (ribociclib); anastrozole; arimidex (anastrozole); aromasin (exemestane); exemestane; femara (letrozole); fulvestrant; letrozole; ribociclib

Status Open

Participating Institutions UW Hospital and Clinics