Breast Neoplasms, Neoplasm Metastasis
Conditions
Brief summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
Interventions
DRUGAbemaciclib
Administered orally
Letrozole or anastrozole administered orally (physician choice)
DRUGFulvestrant
Administered intramuscularly
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer * Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease * Have postmenopausal status * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have adequate organ function * Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy * Are able to swallow oral formulation
Exclusion criteria
* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. * Have clinical evidence or history of central nervous system metastasis. * Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 & 6 inhibitor. * Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted. * Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years. * Have received an autologous or allogeneic stem-cell transplant * Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment. * Are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event | Baseline until end of follow-up (Up To 7 Months) | Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events | Baseline until end of study treatment (Up To 6 Months) | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abemaciclib + NSAI Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care. | 137 |
| Abemaciclib + Fulvestrant Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care. | 63 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance with study drug | 1 | 0 |
| Overall Study | Progressive disease | 9 | 10 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | Abemaciclib + NSAI | Total | Abemaciclib + Fulvestrant |
|---|---|---|---|
| Age, Continuous | 55.60 years STANDARD_DEVIATION 11.66 | 54.40 years STANDARD_DEVIATION 12.05 | 51.80 years STANDARD_DEVIATION 12.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 137 Participants | 200 Participants | 63 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 137 Participants | 200 Participants | 63 Participants |
| Sex: Female, Male Female | 137 Participants | 200 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 137 | 1 / 63 |
| other Total, other adverse events | 105 / 137 | 44 / 63 |
| serious Total, serious adverse events | 9 / 137 | 5 / 63 |
Outcome results
Primary
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline until end of follow-up (Up To 7 Months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abemaciclib + NSAI | Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event | 78.1 percentage of participants |
| Abemaciclib + Fulvestrant | Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event | 69.8 percentage of participants |
Secondary
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Baseline until end of study treatment (Up To 6 Months)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abemaciclib + NSAI | Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events | 3.6 percentage of participants |
| Abemaciclib + Fulvestrant | Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events | 4.8 percentage of participants |