Results from CONTESSA 2: A multinational, multicenter, phase 2 study of tesetaxel (T) plus a reduced dose of capecitabine (C) in patients (pts) with hormone receptor + (HR+), HER2- metastatic breast cancer (MBC) not previously treated with a taxane.
Bibliographic record
Abstract
1061 Research Funding: Odonate Therapeutics, Inc. Background: T is a novel, oral taxane with unique properties, including: oral administration with a low pill burden, a long (8-day) half-life in humans, once-every-3-weeks dosing, no observed hypersensitivity reactions and significant activity against chemotherapy (CT)-resistant breast cancer cell lines. T had encouraging monotherapy activity in a phase 2 study in 38 pts with HR+, HER2- MBC, with a confirmed objective response rate (ORR) per RECIST 1.1 of 45% (Seidman, 2018 ASCO Annual Meeting, Abstract 1042). In CONTESSA, a randomized phase 3 study in 685 pts with HR+, HER2- MBC previously treated with a taxane, T plus a reduced dose of C improved progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC) vs. the approved dose of C alone: median of 9.8 months (mo) vs. 6.9 mo, an improvement of 2.9 mo (HR=0.716; p=0.003) (O'Shaughnessy, SABCS 2020, GS4-01). Methods: CONTESSA 2 is a multinational, multicenter, phase 2 study of T (27 mg/m2 on day 1 of a 21-day cycle) plus a reduced dose of C (1,650 mg/m2/day for 14 days of a 21-day cycle) in pts with HR+, HER2- MBC previously treated with 0-1 prior CT regimens for MBC and not previously treated with a taxane. The primary endpoint is ORR as assessed by the IRC. The secondary efficacy endpoints are duration of response (DoR), PFS and disease control rate (DCR) as assessed by the IRC, and overall survival (OS). Results: 150 pts were enrolled and treated. 80% had visceral disease, 46% had de novo MBC, 52% were previously treated with a CDK 4/6 inhibitor and 33% were ≥65 years old. At the prespecified interim analysis approx 4 mo after the last patient enrolled, the confirmed ORR was 51% (95% CI: 42%-60%), and the unconfirmed ORR was 63% (95% CI: 54%-71%). The median DoR was 9.5 mo (95% CI: 5.4-11.5 mo), the median PFS was 12.9 mo (95% CI: 8.1 mo-NR) and the DCR was 71% (95% CI: 62%-79%). OS data are immature. Grade (Gr) ≥3 treatment-emergent adverse events (TEAEs) occurring in ≥5% of pts were: neutropenia (74.0%), leukopenia (10.7%), hypokalemia (7.3%), anemia (6.7%), hand-foot syndrome (6.0%) and diarrhea (5.3%). Gr 2 alopecia occurred in 11.3% of pts, febrile neutropenia occurred in 4.7% of pts and Gr ≥3 neuropathy occurred in 2.0% of pts. Discontinuation of T and C due to any adverse event occurred in 13.3% of pts. Conclusions: An all-oral regimen of T plus a reduced dose of C demonstrated a high level of antitumor activity in pts with HR+, HER2- MBC not previously treated with a taxane. The confirmed ORR was 51%, median DoR was 9.5 mo and median PFS was 12.9 mo. Neutropenia was the most frequent Gr ≥3 TEAE; the rate of febrile neutropenia was 4.7%. Rates of clinically significant alopecia and neuropathy were low. Clinical trial information: NCT03858972 . Clinical trial information: NCT03858972 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".