Interim results from the full population of the phase 3b CompLEEment-1 study of ribociclib (RIBO) plus letrozole (LET) in the treatment of HR+/HER2– advanced breast cancer (ABC).
Bibliographic record
Abstract
1041 Background: RIBO, an oral, selective inhibitor of CDK4/6 (CDK4/6i), is approved for use in combination with endocrine therapy (ET) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) ABC in multiple countries worldwide. Here we report interim safety and efficacy results from CompLEEment-1, a phase 3b trial evaluating RIBO+LET in an expanded patient (pt) population and the largest CDK4/6i trial in ABC to date. Methods: Pts with HR+, HER2– ABC, ≤1 line of prior chemotherapy (CT), and no prior ET for ABC received RIBO+LET. Treatment regimens and study endpoints have been reported previously (De Laurentiis, et al. ASCO 2018. Poster 1056). Results: Overall, 3,246 pts, who received ≥1 dose of study treatment, were evaluated (cut-off date, August 8, 2018). Median duration of RIBO exposure was 8.1 months (min, 0.0; max, 22.4). Demographic and baseline characteristics indicated a diverse population including men (1.2%), premenopausal women (22.2%), and patients aged ≥70 years (19.5%). Pts were well represented in terms of age, race, and disease history; 5.9% of pts received prior CT for ABC. The only non-hematologic any-cause grade ≥3 AEs ≥5% were increased alanine (7.3%) and aspartate (5.3%) aminotransferase. Treatment-related AEs (any grade) led to discontinuation in 11.4% of pts. Of the 51 (1.6%) on-treatment deaths, 26 were due to study indication and 25 to other reasons. The median time to progression was not estimable (NE) (95% confidence interval [CI], 17.1-NE). Overall response rate was 20.5% (95% CI, 19.1%-21.9%) and clinical benefit rate was 66.1% (95% CI, 64.4%-67.7%). Consistent mean change from baseline in Functional Assessment of Cancer Therapy – Breast Cancer questionnaire scores indicated that pts maintained their quality of life throughout treatment. Conclusions: This interim analysis demonstrates the safety, tolerability, and efficacy of RIBO+LET in a large, diverse cohort of pts with HR+, HER2– ABC who had not previously received ET for ABC. Safety results were consistent with those observed in RIBO pivotal studies and no new safety signals were observed. Clinical trial information: NCT02941926.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".