A phase 2 single-arm study of the clinical activity and safety of enzalutamide in patients with advanced androgen receptor-positive triple-negative breast cancer.
Bibliographic record
Abstract
TPS1144 Background: Androgen receptor (AR) expression is observed in 10-30% of patients (pts) with triple-negative breast cancer (TNBC). Experiments using AR+ TNBC cell lines have demonstrated enhanced growth in response to androgen stimulation that is inhibited by enzalutamide (ENZA), a potent oral inhibitor of AR signaling (Richer JK. Abstract presented at the AACR Advances in Breast Cancer Research Meeting, San Diego, CA, 2013 October 3-6 and D'Amato NC. Abstract presented at the SABCS, San Antonio, TX, December 4-8, 2012). AR+ TNBC may represent a subtype driven by AR signaling and which may respond to ENZA. Methods: Women with advanced AR+ TNBC (ER and PgR <1% by IHC and Her2 normal) will receive daily ENZA (160 mg) until disease progression (NCT01889238). The primary endpoint (EP) is clinical benefit rate (CBR) where benefit is defined as complete or partial response (CR or PR) or stable disease (SD) ≥16 weeks (wks) as assessed by the Investigator and according to RECIST 1.1. Additional EPs include CBR at 24 wks, safety and tolerability, and the relationship between AR signaling and ENZA activity. If the CBR exceeds 2 in 26 pts, the sample size will increase to 62 pts. Any amount of AR expression (local or central) is allowed, submission of tissue is mandatory. Pts may have bone-only non-measurable disease. Brain imaging is required to exclude patients with CNS metastases. Pts with a seizure history are excluded. The primary EP will analyze pts with centrally defined AR+ TNBC (≥10% nuclear staining by IHC) who have ≥1 post-baseline tumor assessment. An ITT analysis will also be reported. The null hypothesis (H0), that the true CBR is 8%, will be tested against a 1-sided alternative. If CBR exceeds 9 in 62 pts in Stage 2, H0will be rejected. This design yields a 1-sided type 1 error rate of 5% and 85% power when the true response rate is 20%. Enrollment is expected to continue through 2014. Clinical trial information: NCT01889238.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".