In this study, patients with advanced breast cancer that was both hormone receptor-positive and HER2-positive, whose disease had not progressed after chemotherapy, had a medicine called palbociclib added to their usual maintenance treatment (a targeted anti-HER2 drug plus hormone therapy). Adding this medicine kept the disease under control for longer on average (about 44 months vs about 29 months). On the other hand, side effects, especially a drop in white blood cells (neutropenia), were more common. The decision to use this medicine should be made with your treating doctor, weighing the benefits and side effects.
HR-positive/HER2-positive advanced or metastatic disease without progression after 4 to 8 cycles of a taxane + trastuzumab (with or without pertuzumab)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Palbociclib | 125 mg | Oral, with or without food, tablet swallowed whole | Once daily, days 1 to 21, every 28 days |
| Trastuzumab (± pertuzumab) | As in those drugs' labels | IV | Every 3 weeks |
| Endocrine therapy (fulvestrant or an aromatase inhibitor) | As in the label | — | — |
On the page “Palbociclib (Ibrance)” · Standard doses (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
HER2-targeted and endocrine maintenance therapy plus palbociclib.
After 4 to 8 cycles of induction therapy: palbociclib 125 mg orally daily for 21 days followed by 7 days off (reduction to 100 and 75 mg allowed) + trastuzumab (6 mg/kg every 3 weeks; loading dose 8 mg/kg if needed) ± pertuzumab (420 mg every 3 weeks; loading dose 840 mg if needed) + endocrine therapy (letrozole, anastrozole, exemestane or fulvestrant); until progression.
HER2-targeted and endocrine maintenance therapy without palbociclib.
The same anti-HER2 and endocrine therapy without palbociclib, until progression.
Source of the regimen details: ClinicalTrials.gov NCT02947685
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with hormone receptor-positive, HER2-positive metastatic breast cancer without disease progression after 4 to 8 cycles of chemotherapy with HER2-targeted therapy.
Primary endpoint: investigator-assessed progression-free survival (PFS). Secondary endpoints: objective response, clinical benefit, safety and overall survival.
Grade 3 adverse events occurred in 79.7% and grade 4 in 10.0% of patients in the palbociclib group, compared with 30.6% and 3.6% in the standard-therapy group. These were mainly due to neutropenia.
This phase 3 trial shows that adding palbociclib to anti-HER2 and endocrine maintenance therapy after response induction with chemotherapy improves progression-free survival in hormone receptor-positive, HER2-positive metastatic breast cancer, at the cost of more adverse events, especially neutropenia. The abstract reports no overall survival result. The status of this approach in clinical guidelines and regulatory approvals should be checked separately.
The study design was open-label and the primary endpoint was investigator-assessed. Overall survival and other secondary endpoint results (objective response and clinical benefit) are not given in the abstract. The marked increase in grade 3 and 4 adverse events in the palbociclib group should be considered in patient selection.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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