Study of clinical effect of Fulvestrant + letrozole + ribociclib triple therapy compared to standard treatment for hormone receptor positive metastatic breast cancer

Comparison of clinical efficacy between letrozole + ribociclib vs. Fulvestrant + letrozole + ribociclib in Hormone receptor positive, HER2 negative metastatic breast cancer – a randomized, phase 2 study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008051

Enrollment

202

Registered

2022-12-30

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : arm A: patients will be received fulvestrant + letrozole + ribociclib combination treatment. Fulvestrant 500mg IM will be administered on day 1, 15, and 28, after then every 4 weeks. Letrozole

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female = 19 years of age - Patients must have histologically confirmed estrogen receptor (ER) or progesterone receptor (PR) positive and HER2-negative invasive breast cancer, as defined by the 2010 and 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines - Patients must have metastatic or advanced inoperable disease : 1) De novo metastatic breast cancer, 2) Recurrent breast cancer diagnosed more than 12 months after completion of adjuvant endocrine therapy. Patients diagnosed with recurrent breast cancer within 12 months after completion of adjuvant tamoxifen treatment will be allowed. - Patients who did not receive any systemic treatment for their metastatic/recurrent breast cancer. - Patients who have measurable or evaluable lesions based on RECIST version 1.1 criteria. - Patients must have ECOG performance status = 2 - Patients must sign and give written informed consent for this protocol in accordance with institutional guidelines - Patients should have adequate organ function within 21 days prior to the start of study treatment (cycle 1, day1). - Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 150 days after the last dose of study medication.

Exclusion criteria

Exclusion criteria: - Patients who received CDK4/6 inhibitor for their metastatic disease - Patients who experienced disease recurrence during adjuvant endocrine therapy with aromatase inhibitor - Uncontrolled CNS metastasis - Patients who are not adequate for endocrine therapy due to visceral crisis.

Design outcomes

Primary

Measure	Time frame
progression free survival rate at 24 months	—

Secondary

Measure	Time frame
progression free survival ;overall survival ;objective response rate ;clinical benefit rate ;safety profiles	—

Countries

Korea, Republic of

Contacts

Public ContactIn Hae Park

Koera University Guro Hospital

parkih@korea.ac.kr+82-2-2626-3172

Outcome results