A Phase 2/3 interventional study of Palbociclib + Letrozole or Fulvestrant in Hormone Receptor Positive HER-2 Negative Breast Cancer, sponsored by Georgetown University. Completed at 6 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Georgetown University · Phase 2/3, Interventional, and Treatment
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia
The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.
An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Adequate bone marrow function:
Exclusion Criteria:
Previous CDK4/6 inhibitor
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Drug: 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
Also known as: Ibrance, Femara, Faslodex
Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
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.
Time frame: 12 months
Dose Delays in Palbociclib Attributed to Neutropenia
Number of patients who required dose delays in palbociclib attributed to neutropenia.
Time frame: 12 months
Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
Number of patients who required dose reductions in palbociclib therapy
Time frame: 12 months
Clinical Benefit Rate
Clinical 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.
Time frame: 24 weeks
| Milestone | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Started | 35 |
| Completed | 35 |
| Not completed | 0 |
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.
| Participants | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event | 35 |
Number of patients who required dose delays in palbociclib attributed to neutropenia.
| Participants | Single ARM |
|---|---|
| Dose Delays in Palbociclib Attributed to Neutropenia | 17 |
Number of patients who required dose reductions in palbociclib therapy
| Participants | Single ARM |
|---|---|
| Dose Reductions in Palbociclib Therapy Attributed to Neutropenia | 13 |
Clinical 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.
| Participants | Single ARM |
|---|---|
| Clinical Benefit Rate | 23 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single ARM | 1/35 (2.9%) | 8/35 (22.9%) | 32/35 (91.4%) |
| Event | Single ARM |
|---|---|
| Acute kidney injuryRenal and urinary disorders | 1/35 |
| AnorexiaMetabolism and nutrition disorders | 1/35 |
| ColitisGastrointestinal disorders | 1/35 |
| DiarrheaGastrointestinal disorders | 1/35 |
| FeverGeneral disorders | 1/35 |
| Heart failureCardiac disorders | 1/35 |
| HematomaVascular disorders | 1/35 |
| Neutrophil count decreasedInvestigations | 1/35 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 1/35 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 1/35 |
| Event | Single ARM |
|---|---|
| Neutrophil count decreasedInvestigations | 17/35 |
| FatigueGeneral disorders | 16/35 |
| AnemiaBlood and lymphatic system disorders | 12/35 |
| White blood cell decreasedInvestigations | 10/35 |
| Abdominal PainGastrointestinal disorders | 6/35 |
| Hot flashesVascular disorders | 6/35 |
| NauseaGastrointestinal disorders | 5/35 |
| AnorexiaMetabolism and nutrition disorders | 4/35 |
| ConstipationGastrointestinal disorders | 4/35 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/35 |
| Age, Categorical(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 15 |
| Sex: Female, Male(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Female | 35 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 35 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| United States | 35 |
| HR+/HER2- ABC(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Count of participants | 35 |
| Baseline absolute neutrophil count ≥1000/mm3(Participants) | Palbociclib + Letrozole or Fulvestrant |
|---|---|
| Count of participants | 35 |
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