Neoadjuvant Treatment of Locally-advanced Breast Cancer Patients With Ribociclib and Letrozole

Sponsor
University Hospital, Akershus
Study ID
NCT05163106
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer
  • ER-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Locally Advanced Breast Cancer
  • Luminal A Breast Cancer
  • Luminal B Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letrozole 2.5mg oral tablet; Ribociclib 600mg oral tablet — DRUG
    Patients will be given letrozole 2.5mg and ribociclib 600mg daily, per oral for a period of 21 days followed by 7 days of letrozole only.
  • Goserelin — DRUG
    Premenopausal women will be given goserelin 3.6 mg (subcutaneous) every 4 weeks in concert with their Letrozole and Ribociclib treatment.

Study Details

Patients with locally advanced (stage III) breast cancer (LABC) are characterized by a significantly worse prognosis compared to patients with primarily operable breast cancer. While neoadjuvant chemotherapy has been the first choice in this situation for several decades, recent evidence suggests that some patients may experience an extraordinary effect from neoadjuvant endocrine treatments involving aromatase inhibitors as monotherapy or in modern drug combinations.Selected LABC patients admitted for treatment will be offered combination therapy including letrozole and ribociclib. The overall goal of the project is to improve understanding of tumor responses and resistance in patients suffering from ER-positive/HER-2 negative locally advanced breast cancer, focusing on the role of the immune system including the gut microbiome.

Key Dates

Start date
Dec 1, 2022
Status verified
Aug 2024
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
85 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib and Letrozole Arm
    Patients entered into this study will be given letrozole (FemarTM) in combination with ribociclib (KisqaliTM) for at least 6 months. Premenopausal women will also receive treatment with goserelin 3.6 mg s.c. every 4 weeks.

Primary Outcome Measure

To study the change in levels of direct and indirect immunologic biomarkers of targeted cancer therapy with letrozole and ribociclib given in combination for patients with locally-advanced, ER-positive, HER-2 negative, luminal A7B breast cancer [ Time Frame: Baseline, Day 21 and at time of surgery (Day 180) ]

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