Summary of Study ST003315
This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR002062. The data can be accessed directly via it's Project DOI: 10.21228/M82Z4P This work is supported by NIH grant, U2C- DK119886.
See: https://www.metabolomicsworkbench.org/about/howtocite.php
This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.
| Study ID | ST003315 |
| Study Title | Randomized phase II trial of pre-operative fulvestrant with or without enzalutamide for ER+/Her2- primary breast cancer: effects on tumor immune microenvironment and clinical outcomes. |
| Study Summary | This randomized phase II trial of 4 months of neoadjuvant fulvestrant (Fulv) alone or with enzalutamide (Combo) assessed whether the addition of AR blockade to Fulv would limit residual tumor at time of surgery, as measured by modified preoperative endocrine predictive index (PEPI) score. Eligible patients were women with ER+/HER2- primary BC cT2 or greater. Lithium-heparin (LiHep) plasma samples were obtained every 4 weeks until surgery and one month after surgery then analyzed by MS-based metabolomics. |
| Institute | University of Colorado Anschutz Medical Campus |
| Last Name | Haines |
| First Name | Julie |
| Address | 12801 E 17th Ave, Room 1303, Aurora, Colorado, 80045, USA |
| julie.haines@cuanschutz.edu | |
| Phone | 3037243339 |
| Submit Date | 2024-06-28 |
| Raw Data Available | Yes |
| Raw Data File Type(s) | raw(Thermo) |
| Analysis Type Detail | LC-MS |
| Release Date | 2024-08-01 |
| Release Version | 1 |
Select appropriate tab below to view additional metadata details:
Factors:
Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)
| mb_sample_id | local_sample_id | Sample source | Histology | Lab Ki67 Group | PEPI Score | Visit | Arm |
|---|---|---|---|---|---|---|---|
| SA359418 | AG-54 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Combination |
| SA359419 | AG-45 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Combination |
| SA359420 | AG-80 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Combination |
| SA359421 | AG-72 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Fulvestrant |
| SA359422 | AG-98 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Fulvestrant |
| SA359423 | AG-28 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Fulvestrant |
| SA359424 | AG-109 | Plasma | Ductal | High BL, High W5 | >0 | Baseline | Fulvestrant |
| SA359425 | AG-81 | Plasma | Ductal | High BL, High W5 | >0 | C4D1 | Combination |
| SA359426 | AG-55 | Plasma | Ductal | High BL, High W5 | >0 | C4D1 | Combination |
| SA359427 | AG-29 | Plasma | Ductal | High BL, High W5 | >0 | C4D1 | Fulvestrant |
| SA359428 | AG-99 | Plasma | Ductal | High BL, High W5 | >0 | C4D1 | Fulvestrant |
| SA359429 | AG-73 | Plasma | Ductal | High BL, High W5 | >0 | C4D1 | Fulvestrant |
| SA359430 | AG-39 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Combination |
| SA359431 | AG-35 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Combination |
| SA359432 | AG-106 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Combination |
| SA359433 | AG-88 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Combination |
| SA359434 | AG-86 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Combination |
| SA359435 | AG-13 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359436 | AG-60 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359437 | AG-56 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359438 | AG-48 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359439 | AG-11 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359440 | AG-90 | Plasma | Ductal | High BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359441 | AG-87 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Combination |
| SA359442 | AG-107 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Combination |
| SA359443 | AG-89 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Combination |
| SA359444 | AG-40 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Combination |
| SA359445 | AG-36 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Combination |
| SA359446 | AG-61 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359447 | AG-49 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359448 | AG-91 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359449 | AG-57 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359450 | AG-12 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359451 | AG-14 | Plasma | Ductal | High BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359452 | AG-46 | Plasma | Ductal | Low BL, Low W5 | 0 | Baseline | Combination |
| SA359453 | AG-74 | Plasma | Ductal | Low BL, Low W5 | 0 | Baseline | Combination |
| SA359454 | AG-26 | Plasma | Ductal | Low BL, Low W5 | 0 | Baseline | Combination |
| SA359455 | AG-75 | Plasma | Ductal | Low BL, Low W5 | 0 | C4D1 | Combination |
| SA359456 | AG-27 | Plasma | Ductal | Low BL, Low W5 | 0 | C4D1 | Combination |
| SA359457 | AG-47 | Plasma | Ductal | Low BL, Low W5 | 0 | C4D1 | Combination |
| SA359458 | AG-70 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359459 | AG-110 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359460 | AG-104 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359461 | AG-9 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359462 | AG-58 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359463 | AG-78 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359464 | AG-51 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359465 | AG-50 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359466 | AG-68 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359467 | AG-82 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359468 | AG-84 | Plasma | Ductal | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359469 | AG-105 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359470 | AG-10 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359471 | AG-71 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359472 | AG-111 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359473 | AG-59 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359474 | AG-85 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359475 | AG-79 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359476 | AG-83 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359477 | AG-69 | Plasma | Ductal | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359478 | AG-52 | Plasma | Ductal | not available | 0 | Baseline | Combination |
| SA359479 | AG-37 | Plasma | Ductal | not available | 0 | Baseline | Combination |
| SA359480 | AG-53 | Plasma | Ductal | not available | 0 | C4D1 | Combination |
| SA359481 | AG-38 | Plasma | Ductal | not available | 0 | C4D1 | Combination |
| SA359482 | AG-76 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359483 | AG-18 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359484 | AG-100 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359485 | AG-43 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359486 | AG-20 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359487 | AG-96 | Plasma | Ductal | not available | >0 | Baseline | Combination |
| SA359488 | AG-65 | Plasma | Ductal | not available | >0 | Baseline | Fulvestrant |
| SA359489 | AG-64 | Plasma | Ductal | not available | >0 | Baseline | Fulvestrant |
| SA359490 | AG-94 | Plasma | Ductal | not available | >0 | Baseline | Fulvestrant |
| SA359491 | AG-21 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359492 | AG-44 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359493 | AG-101 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359494 | AG-77 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359495 | AG-97 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359496 | AG-19 | Plasma | Ductal | not available | >0 | C4D1 | Combination |
| SA359497 | AG-66 | Plasma | Ductal | not available | >0 | C4D1 | Fulvestrant |
| SA359498 | AG-95 | Plasma | Ductal | not available | >0 | C4D1 | Fulvestrant |
| SA359499 | AG-108 | Plasma | Ductal | not available | >0 | C4D1 | Fulvestrant |
| SA359500 | AG-7 | Plasma | Lobular | High BL, High W5 | >0 | Baseline | Combination |
| SA359501 | AG-8 | Plasma | Lobular | High BL, High W5 | >0 | C4D1 | Combination |
| SA359502 | AG-1 | Plasma | Lobular | High BL, Low W5 | 0 | Baseline | Combination |
| SA359503 | AG-2 | Plasma | Lobular | High BL, Low W5 | 0 | C4D1 | Combination |
| SA359504 | AG-3 | Plasma | Lobular | Low BL, Low W5 | 0 | Baseline | Fulvestrant |
| SA359505 | AG-5 | Plasma | Lobular | Low BL, Low W5 | 0 | Baseline | Fulvestrant |
| SA359506 | AG-4 | Plasma | Lobular | Low BL, Low W5 | 0 | C4D1 | Fulvestrant |
| SA359507 | AG-6 | Plasma | Lobular | Low BL, Low W5 | 0 | C4D1 | Fulvestrant |
| SA359508 | AG-15 | Plasma | Lobular | Low BL, Low W5 | >0 | Baseline | Combination |
| SA359509 | AG-41 | Plasma | Lobular | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359510 | AG-24 | Plasma | Lobular | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359511 | AG-92 | Plasma | Lobular | Low BL, Low W5 | >0 | Baseline | Fulvestrant |
| SA359512 | AG-16 | Plasma | Lobular | Low BL, Low W5 | >0 | C4D1 | Combination |
| SA359513 | AG-42 | Plasma | Lobular | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359514 | AG-93 | Plasma | Lobular | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359515 | AG-25 | Plasma | Lobular | Low BL, Low W5 | >0 | C4D1 | Fulvestrant |
| SA359516 | AG-22 | Plasma | Lobular | not available | 0 | Baseline | Combination |
| SA359517 | AG-23 | Plasma | Lobular | not available | 0 | C4D1 | Combination |
