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Two large trials found that adding palbociclib after surgery does not prevent recurrence, even though the same drug helps in metastatic disease.
PALLAS and PENELOPE-B, led by trial NCT02513394 and sponsored by ABCSG, the Alliance, the German Breast Group and Pfizer, were two large trials reported in 2020 that found adding palbociclib after surgery does not prevent recurrence in HR-positive, HER2-negative early breast cancer, even though the same drug helps in metastatic disease. PALLAS gave two years of palbociclib with endocrine therapy to 5,796 women and PENELOPE-B gave one year to 1,250 women with residual disease after neoadjuvant chemotherapy, and neither improved invasive disease-free survival, with no survival difference at PENELOPE-B's final analysis. OnCo links them to CDK4/6 as a target, palbociclib, Miguel Martín and the Austrian Breast and Colorectal Cancer Study Group. Whether duration, dose intensity or drug differences explain the split is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
6,862 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 4-year invasive disease-free survival (PALLAS)primary | Palbociclib + ET | - | 84.2% | 0.96 (0.81 to 1.14) | - | link |
| ET alone | - | 84.5% |
Shares Palbociclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, HR-positive / HER2-negative breast cancer and the tag failure.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Palbociclib, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Palbociclib, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors.
Shares High-risk early HR-positive breast cancer, Palbociclib, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares CDK4/6, Palbociclib, HR-positive / HER2-negative breast cancer.