NCT02632045

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

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 +, HER2 - Breast Cancer (MAINTAIN Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Melissa K Accordino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar toxicity and drug profile and mechanism of action, the investigators feel that it is appropriate for patients to receive either drug with an aromatase inhibitor prior to randomization.

Detailed description

Despite advances in early detection and therapeutic options, unresectable or metastatic breast cancer remains incurable and is one of the leading causes of cancer-related mortality. Breast cancer is a molecularly heterogeneous disease. This study will be evaluating estrogen receptor (ER) expression positivity and/or progesterone receptor (PgR) positivity of breast cancer with the absence of over-expression or amplification of HER2. Inhibitors of the cyclin dependent kinases 4 and 6 (CDK4/6) have been developed and demonstrated impressive activity in patients with ER-positive HER2-negative breast cancer with marked improvements in progression free survival. This question is asking whether CDK 4/6 inhibition should be continued with hormone therapy in patients who will be switching their hormone therapy in the metastatic breast cancer setting.

Conditions

• Metastatic Breast Cancer
• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	LEE-011	600 mg capsule (3x 200 mg capsules)
DRUG	Fulvestrant	500 mg injection
DRUG	Placebo	600 mg capsule (3x 200 mg capsules)

Timeline

• Start date: 2016-03-01
• Primary completion: 2022-01-04
• Completion: 2022-01-04
• First posted: 2015-12-16
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study