Trial Outcomes & Findings for Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (NCT NCT02692755)
NCT ID: NCT02692755
Last Updated: 2021-09-28
Results Overview
For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of \>38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity.
COMPLETED
PHASE2/PHASE3
35 participants
12 months
2021-09-28
Participant Flow
Participant milestones
| Measure |
Palbociclib + Letrozole or Fulvestrant
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
Baseline characteristics by cohort
| Measure |
Palbociclib + Letrozole or Fulvestrant
n=35 Participants
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
|
HR+/HER2- ABC
|
35 Participants
n=99 Participants
|
|
Baseline absolute neutrophil count ≥1000/mm3
|
35 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsFor study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of \>38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity.
Outcome measures
| Measure |
Palbociclib + Letrozole or Fulvestrant
n=35 Participants
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
|
35 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Including all patients who completed ≥1 treatment cycle
Number of patients who required dose delays in palbociclib attributed to neutropenia.
Outcome measures
| Measure |
Palbociclib + Letrozole or Fulvestrant
n=33 Participants
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Dose Delays in Palbociclib Attributed to Neutropenia
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Including all patients who completed ≥1 treatment cycle
Number of patients who required dose reductions in palbociclib therapy
Outcome measures
| Measure |
Palbociclib + Letrozole or Fulvestrant
n=33 Participants
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 weeksClinical Benefit Rate (CBR), for those with evaluable disease, defined as the percentage of patients who achieved complete response, partial response and stable disease. RECIST 1.1 was used as the standard way to measure response to treatment. The mean (SD) of specific metabolites were calculated at each time point and graphically assess these measures over time with clinical response and hematological toxicity. The mean change in these variables from baseline to each follow-up point was be calculated. Generalized linear model was utilized for the correlative analysis of clinical response and hematologic events.
Outcome measures
| Measure |
Palbociclib + Letrozole or Fulvestrant
n=33 Participants
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Clinical Benefit Rate
|
23 Participants
|
Adverse Events
Single ARM
Serious adverse events
| Measure |
Single ARM
n=35 participants at risk
Palbociclib + Letrozole or Fulvestrant
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
General disorders
Fever
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart failure
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Vascular disorders
Hematoma
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Single ARM
n=35 participants at risk
Palbociclib + Letrozole or Fulvestrant
Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
17.1%
6/35 • Number of events 8 • 12 months
|
|
Investigations
Alkaline Phosphate Increased
|
8.6%
3/35 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
34.3%
12/35 • Number of events 20 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
11.4%
4/35 • Number of events 4 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
3/35 • Number of events 5 • 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
11.4%
4/35 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 5 • 12 months
|
|
Investigations
Creatinine increased
|
5.7%
2/35 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.6%
3/35 • Number of events 3 • 12 months
|
|
General disorders
Edema limbs
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
General disorders
Fatigue
|
45.7%
16/35 • Number of events 21 • 12 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
2/35 • Number of events 9 • 12 months
|
|
General disorders
Flu like symptoms
|
8.6%
3/35 • Number of events 3 • 12 months
|
|
Vascular disorders
Hot flashes
|
17.1%
6/35 • Number of events 6 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.7%
2/35 • Number of events 3 • 12 months
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
4/35 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 5 • 12 months
|
|
Investigations
Neutrophil count decreased
|
48.6%
17/35 • Number of events 51 • 12 months
|
|
General disorders
Pain
|
11.4%
4/35 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 3 • 12 months
|
|
Nervous system disorders
Paresthesia
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Investigations
Platelet count decreased
|
11.4%
4/35 • Number of events 6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Infections and infestations
Upper respiratory infection
|
5.7%
2/35 • Number of events 2 • 12 months
|
|
Investigations
White blood cell decreased
|
28.6%
10/35 • Number of events 41 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place