Trial Outcomes & Findings for Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial) (NCT NCT05554354)

Results Overview

ORR is the percentage of patients who reaches a complete or partial response (defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version\[v\]1.1) within 4 months of the start of the treatment. ORR will be calculated as the proportion of patients achieved partial response (PR) or complete response (CR) within 4 months after the initiation of the treatment. ORR will be reported with corresponding 95% exact CI. Patients who have withdrawn from the study before any efficacy follow up are considered non-evaluable for clinical response and will be replaced.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Within 4 months of the start of treatment

Results posted on

2026-03-03

Participant Flow

The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Participant milestones

Participant milestones
Measure	Cohort I (Arm I) (Fulvestrant, Binimetinib) Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study. Binimetinib: Given PO Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Bone Scan: Undergo bone scan Computed Tomography: Undergo CT scan Echocardiography Test: Undergo ECHO Fulvestrant: Given IM Magnetic Resonance Imaging: Undergo MRI Multigated Acquisition Scan: Undergo MUGA	Cohort I (Arm II) Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Bone Scan: Undergo bone scan Computed Tomography: Undergo CT scan Echocardiography Test: Undergo ECHO Fulvestrant: Given IM Magnetic Resonance Imaging: Undergo MRI Multigated Acquisition Scan: Undergo MUGA	Cohort II (Fulvestrant, Binimetinib) Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study. Binimetinib: Given PO Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Bone Scan: Undergo bone scan Computed Tomography: Undergo CT scan Echocardiography Test: Undergo ECHO Fulvestrant: Given IM Magnetic Resonance Imaging: Undergo MRI Multigated Acquisition Scan: Undergo MUGA
Overall Study STARTED	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: The duration between randomization and progression or death from all cause, whichever happens first, assessed up to 5 years