Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer (NCT NCT04031885)

Last Updated: 2021-08-24

Results Overview

ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to the corresponding treatment arm \[intent-to-treat (ITT) population\], based on investigator-assessed tumor responses.CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking in reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Confirmations of CR and PR are not required.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Randomization to Measured Progressive Disease (Up to 12 Months)

Results posted on

2021-08-24

Participant Flow

The study was terminated early as a business decision based on the inability to enroll subjects into the trial.

Participants who have had at least one adequate tumor assessment at baseline and post-baseline and are off study treatment are considered to have completed the study.

Participant milestones

Participant milestones
Measure	Abemaciclib + Fulvestrant 150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.	Standard Chemotherapy Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Overall Study STARTED	1	3
Overall Study Received Any Quantity of Study Treatment	1	1
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib + Fulvestrant n=1 Participants 150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection on C1D1 and C1D15, then Day 1 of each subsequent cycle.	Standard Chemotherapy n=3 Participants Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to Measured Progressive Disease (Up to 12 Months)

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	Abemaciclib + Fulvestrant n=1 Participants 150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection C1D1 and C1D15, then Day 1 of each subsequent cycle.	Standard Chemotherapy n=3 Participants Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: First Dose Date to Objective Progression or Death Due to Any Cause (Up to 12 Months)

Population: Zero participants analyzed, no data collected.

PFS is defined as the time from first dose date until the first occurrence of documented disease progression per Response Criteria In Solid Tumors version 1.1(RECIST v1.1) or death from any cause in the absence of progressive disease. Progression-free survival will be based on investigator-assessed tumor responses; there will not be an independent central review of imaging data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First Dose to Date of CR or PR (Up to 12 Months)

Population: Zero participants analyzed, no data collected.

TTR is defined as the time from first dose date until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 12 Months)

Population: Zero participants analyzed, no data collected.

DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization to Second Objective Progression or Death Due to Any Cause (Up to 12 Months)

Population: Zero participants analyzed, no data collected.

PFS 2 is defined as the time from first dose date to the disease progression date on next line (first line of post-discontinuation treatment), or starting date of the second line of post-discontinuation treatment or death from any cause, whichever is earlier, or death from any cause, whichever is earlier.

Outcome measures

Outcome data not reported

Adverse Events

Abemaciclib + Fulvestrant

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Standard Chemotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib + Fulvestrant n=1 participants at risk 150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection C1D1 and C1D15, then Day 1 of each subsequent cycle.	Standard Chemotherapy n=3 participants at risk Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Abemaciclib + Fulvestrant n=1 participants at risk 150 mg Abemaciclib given orally BID with 500 mg fulvestrant given by IM injection C1D1 and C1D15, then Day 1 of each subsequent cycle.	Standard Chemotherapy n=3 participants at risk Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Cardiac disorders Tachycardia	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Eye disorders Dry eye	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Eye disorders Eye irritation	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Eye disorders Lacrimation increased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 2 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Eye disorders Swelling of eyelid	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	66.7% 2/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Dyspepsia	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Oral pain	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Gastrointestinal disorders Vomiting	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
General disorders Mucosal inflammation	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
General disorders Mucosal pigmentation	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
General disorders Oedema peripheral	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
General disorders Peripheral swelling	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
General disorders Pyrexia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Infections and infestations Abscess jaw	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Infections and infestations Clostridium difficile infection	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Blood calcium decreased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Blood creatinine increased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Lymphocyte count decreased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 4 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations Platelet count decreased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Investigations White blood cell count decreased	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Metabolism and nutrition disorders Decreased appetite	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 2 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Nervous system disorders Depressed level of consciousness	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Nervous system disorders Hyperaesthesia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 4 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Nervous system disorders Seizure	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Nervous system disorders Taste disorder	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Psychiatric disorders Anxiety	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Renal and urinary disorders Micturition urgency	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 2 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	66.7% 2/3 • Number of events 3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	66.7% 2/3 • Number of events 6 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	33.3% 1/3 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.
Vascular disorders Hypotension	100.0% 1/1 • Number of events 1 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.	0.00% 0/3 • Baseline up to 12 months All randomized participants who received any quantity of study treatment.