Phase 2
Completed N=93
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
Estrogen Receptor-Positive Breast Cancer · HER2/Neu Negative · Stage IV Breast Cancer AJCC v6 and v7
Source: ClinicalTrials.gov NCT03633331 ↗
Enrolled (actual)
93
Serious AEs
38.0%
Results posted
Oct 2021
Primary outcomePrimary: Incidence of Adverse Events — 0.756 proportion of patients
Summary
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
0.756 | — |
| SECONDARY Commonality of Grade 3+ Drug Toxicities |
62.6 | — |
| SECONDARY Dose Reduction, Dose Hold, and Hospitalization Reasons |
24; 0; 0; 2; 1; 10 | — |
| SECONDARY Time to Treatment Failure (and Reason for Coming Off Study - Toxicity, Patient Preference, Progression) |
450 | — |
| SECONDARY Palbociclib Adherence Rate |
100; 94.3; 97.6 | — |
| SECONDARY Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) |
55 | — |
| SECONDARY Progression Free Survival (PFS) |
895 | — |
| SECONDARY Overall Survival (OS) |
1084 | — |
| SECONDARY Overall Treatment Utility (OTU) Results |
6; 28; 26 | — |
| SECONDARY Sarcopenia Analysis |
— | — |
| SECONDARY Quality of Life as Measured by the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L) |
0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required
- Measurable disease or non-measurable disease
- Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration
- No prior therapy with a CDK inhibitor
- Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade = = 3 years
- No active infection requiring treatment with antibiotics
- Patients must be able to swallow and retain oral medication
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patients must be able to read and comprehend English or Spanish
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count >= 100, 000/mm^3 (100 x 10^9/L)
- Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)
Data sourced from ClinicalTrials.gov (NCT03633331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.