Title
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Description
This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
Collection of Correlative Samples at First Recurrence (Stage I consent) If feasible, optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence. Patients should then complete radiation therapy if that is indicated. Enrollment to the Treatment Phase will occur within 6 months of the last local treatment, surgery or radiation treatment, whichever occurred last.

Study Treatment (Stage II/ main consent)

Treatment includes:

Ribociclib:

Oral ribociclib at a dose of 600 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice.

Physician's Choice Endocrine Therapy:
ET consists of one of the following:

Intramuscular fulvestrant
Oral anastrozole
Oral letrozole
Oral exemestane
Concomitant use with tamoxifen is not allowed.
Ribociclib administration is planned for 36 months and ET administration is planned for 60 months.

Objective
Primary Objective:
To estimate subsequent recurrence-free survival (RFS) at 3 years
for ribociclib when administered with ET (AIs or fulvestrant), in
patients with Hormone Receptor (HR) positive, HER2 negative
breast cancer with adequately resected local recurrence of early
breast cancer (EBC).
Secondary Objectives:
To estimate distant metastasis-free survival
To estimate overall survival (OS).
To evaluate safety and tolerability
To identify predictors of loco-regional recurrence.

Treatment Experimental: Investigational Group
The drug ribociclib will be taken orally at a dose of 600 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice.

Physician's choice of endocrine therapy includes:

500 mg of fulvestrant received intramuscularly. This will be taken on Day 1 and Day 15 of Cycle 1 and on Day 1 of Cycle 2 and beyond.
1 mg of anastrozole taken orally daily of the 28 day cycle.
2.5 mg of letrozole taken orally daily of the 28 day cycle.
25 mg of exemestane taken orally daily of the 28 day cycle.
Concomitant use with tamoxifen is not allowed.
Premenopausal subjects must also be treated with ovarian suppression according to institutional standards or have undergone bilateral oophorectomy.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Breast

Participating Institutions
UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital