Trial Outcomes & Findings for Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer (NCT NCT04305236)

Last Updated: 2023-06-06

Results Overview

This is defined as the percentage of subjects who achieve a pathological complete response (pCR). A pCR is defined by no evidence of tumor cells in the final surgical specimen.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

From start of study treatment to surgery, on average we expect 6 months.

Results posted on

2023-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib and Fulvestrant Abemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days. Abemaciclib: Given PO Fulvestrant: Given Intramuscularly
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib and Fulvestrant n=1 Participants Abemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days. Abemaciclib: Given PO Fulvestrant: Given Intramuscularly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Data not collected

This is defined as the percentage of subjects who achieve a pathological complete response (pCR). A pCR is defined by no evidence of tumor cells in the final surgical specimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Data not collected

To assess the overall response rate to the combination of Abemaciclib and Fulvestrant. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Percentage of participants could not be analyzed due to early study termination.

This is defined as the percentage of subjects who undergo breast conserving surgery after receiving Abemaciclib and Fulvestrant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: Data not collected

Recurrence disease free survival will be defined as the time from surgery until patient develops recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Refer to the adverse event table for specifics. There were no reported adverse events.

To evaluate the safety and tolerability of administering Abemaciclib and Fulvestrant. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Outcome measures

Outcome measures
Measure	Abemaciclib and Fulvestrant n=1 Participants Abemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days. Abemaciclib: Given PO Fulvestrant: Given Intramuscularly
Percentage of Grade 3-5 Adverse Events	0 percentage of participants

SECONDARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Data not collected.

Percentage change in the Ki 67 will be evaluated from baseline to the treated specimen after breast surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of study treatment to surgery, on average we expect 6 months.

Population: Data not collected.

The preoperative endocrine prognostic index (PEPI) Score is a score that is used in clinical trials to assess response to Neo-Adjuvant endocrine therapy. The PEPI score takes into account the tumor and nodal stage, level of ER expression and Ki 67 following neoadjuvant endocrine therapy.

Outcome measures

Outcome data not reported

Adverse Events

Abemaciclib and Fulvestrant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

UC Irvine Health / Chao Family Comprehensive Cancer Center

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place