NSABP FB-6: Phase II trial of weekly paclitaxel (WP) and pazopanib following doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for HER2-negative locally advanced breast cancer (LABC).
Bibliographic record
Abstract
1025 Background: Pazopanib is an oral, small molecule inhibitor of VEGFR-1, -2, and-3, PDGFR-α, and -β, and c-kit tyrosine kinases. The purpose of this trial was to determine the activity and safety profile of pazopanib when added to neoadjuvant WP following AC in LABC. The primary endpoint was pathologic complete response in the breast and nodes (pCR-BN). Methods: Women with HER2-negative stage IIIA-IIIC breast cancer were treated with AC (60 mg/m2/600 mg/m2) for 4 cycles every 3 weeks followed by WP 80 mg/m2 on days 1, 8, and 15 every 28 days for 4 cycles concurrently with pazopanib 800 mg orally daily prior to surgery. Postoperatively, pazopanib was given for 6 months. The regimen would be considered active if ≥14 responses (16% pCR rate in breast and nodes) were observed in 87 evaluable patients. Patients were considered evaluable if they received at least 1 dose of pazopanib. Results: Between July 2009 and March 2011, 101 pts (median age 51 yrs, range 30-71) were enrolled; 56% had stage IIIA, 34% stage IIIB, and 10% stage IIIC disease. 74 pts (73%) had ER-and/or PR-positive tumors and 27 pts (27%) were triple negative. 8 patients did not begin pazopanib. The pCR-BN rate in evaluable patients for whom surgical information was known was 18% (16/89). The pCR-BN rate in ER positive disease was 9% (6/65) and was 42% (10/24) in TNBC. Toxicities observed with WP and pazopanib included diarrhea (gr 2/3, 10%/5%), hand-foot syndrome (gr 2/3, 11%/1%), hypertension (gr 2/3, 12%/3%), neuropathy (gr 2/3, 14%/1%), and neutropenia (gr 3/4, 25%/1%). Liver toxicity during WP and pazopanib included ALT (gr 2/3/4, 13%/7%/1%), AST (gr 2/3, 7%/7%), and total bilirubin (gr 2, 2%). Conclusions: A regimen of WP and pazopanib following AC was active as neoadjuvant therapy in women with LABC and met the pre-specified criteria of interest. The activity in TNBC was notable. The toxicity profile of WP and pazopanib was consistent with previous experience. Support: GlaxoSmithKline.
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 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 | 0.003 |
| 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".