Phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with weekly paclitaxel (WP) or eribulin (E) followed by doxorubicin and cyclophosphamide (AC) in women with locally advanced HER2-negative breast cancer (LABC): NSABP FB-9.
Bibliographic record
Abstract
1058 Background: Eribulin (E) is a non-taxane, tubulin- and microtubule-targeting agent. In the randomized, phase III EMBRACE trial, disease-free survival and overall survival were prolonged in E versus physician's choice in heavily pretreated patients (pts). In this phase II randomized neo-adjuvant clinical trial, WP or E is followed by AC in patients with HER-2 negative LABC. The primary endpoint was pathologic complete response (pCR) in the breast and nodes. Methods: A total of 50 pts with LABC were accrued between January and August 2013. Median age was 50.5 years (range: 29-70 years). Twenty-three pts had stage IIB, 16 had stage IIIA, 9 had stage IIIB, and 2 had stage IIIC. Four pts had inflammatory breast cancer. Thirty-three were hormone-receptor positive and 17 were triple negative. Pts were randomly assigned (2:1) to receive either E (n= 31) (1.4 mg/m2 day 1 and day 8) every 3 weeks for 4 cycles, or WP (n= 19) (80 mg/m2) for 12 treatments. Both groups received AC (60 mg/m2 and 600 mg/m2) every 3 weeks for 4 cycles before surgery. Pts were evaluated by clinical examination and breast MRI at baseline and after completion of E or WP. MRI clinical partial response was defined as ≥30% decrease in tumor diameter. Results: Significant grade 3 toxicities included diarrhea (2%), febrile neutropenia (2%), mucositis (2%), and thromboembolic events (2%), 1 pt each. No pt experienced grade 3 or higher neuropathy. Baseline and follow-up MRI results are available on 44 pts. In the WP arm, 15/18 (83%) pts had a response (14 PR and 1 CR) and in the E arm, 15/26 (57%) had response (14 PR and 1 CR), either by investigator and/or central review. By central review WP pts had 50% response and E had 45%. Primary endpoint of pCR results will be reported. Conclusions: Both regimens are well tolerated with no unexpected toxicities. Both E and WP had moderate activity as per imaging in this LABC. A full analysis of complete pathological response data is pending. Clinical trial information: NCT01705691.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
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".