Trials — SABCS 2026¶
The primary artifact of this vault: one Markdown file per trial / readout. SABCS 2026 is a breast-cancer clinical-readout meeting, so the unit of analysis is the trial — not the speaker, not the tool, not the company.
Status: Template + master index. Per-trial pages will be populated as the SABCS 2026 program is released (Oct–Nov 2026) and embargoes lift (day of presentation, Dec 8–11). Pre-meeting stubs flagged
*expected, subject to embargo*are sourced from company toplines, prior-year readouts, JPM 2026 sponsor guidance, and analyst preview pieces; trial identities and numbers can shift on the actual abstract reveal.
Per-trial template¶
Each trial file (e.g., monarche-7yr.md, destiny-breast09.md) follows this schema. Copy and fill:
# <Trial acronym / name> — <Drug regimen, indication, line>
> **Abstract:** <abstract #, e.g., GS1-01> · **Session:** <session name, date, time CT, hall> · **Embargo:** <date>
## At a glance
- **Sponsor:** <pharma / cooperative group>
- **PI / presenter:** <name, institution>
- **NCT ID:** <NCTxxxxxxxx>
- **Phase:** <1 / 2 / 3 / 2-3>
- **Design:** <arms, randomization, blinding>
- **N:** <enrolled / analyzed>
- **Primary endpoint(s):** <iDFS / EFS / PFS / OS / pCR / ORR>
- **Comparator:** <SOC / placebo / active comparator>
- **Indication:** <HR+/HER2-, HER2+, TNBC; biomarker selection: HER2-low/ultralow, ESR1-mut, BRCA, PD-L1>
- **Line:** <neoadjuvant / adjuvant / 1L MBC / 2L MBC / 3L+ MBC>
## Headline result
<One paragraph. Numbers + HR + p-value if known. If pre-embargo, mark
`*expected per <company> topline <date>*` or `*pre-embargo per <analyst source>*`.>
## Mechanism / class
<Drug class, target, prior approvals if any. Cross-link to related AACR mechanism sessions
or prior SABCS readouts in the same series (e.g., DESTINY-Breast lineage).>
## Discussant takeaway
<Named discussant / session chair + key framing once known. SABCS uses session-level
discussants rather than per-abstract — capture the GS session chair framing.>
## Practice-changing?
<Yes / no / pending, with rationale: NCCN breast guideline implications, FDA filing path,
unmet need, prior SOC. SABCS is the venue where most NCCN breast updates originate.>
## Cross-links
- **SABCS prior years:** <e.g., monarchE original GS5 2020; KEYNOTE-756 GS01 2023>
- **AACR 2026:** <related mechanism / biomarker session>
- **ASCO 2026:** <e.g., ASCENT-04 PFS1 LBA1000, SERENA-6 PFS1 Plenary>
- **ESMO 2026:** <prior interim readouts>
- **JPM 2026:** <sponsor presentation / pipeline framing>
- **Other SABCS 2026 trials:** <same class, same target>
## Sources
- *Cancer Research* SABCS abstract: <DOI or "pending day of presentation">
- Company press release: <URL>
- Trade-press recap: <OncLive / ASCO Post / Targeted Oncology / CancerNetwork URL>
- ClinicalTrials.gov: <NCT URL>
Master trial index¶
The shortlist for pre-meeting stub creation. All entries below are anticipated — sourced from prior-year SABCS slots, JPM 2026 sponsor guidance, ongoing-trial timelines, and analyst preview material. Trial slot assignments (GS numbers) are unknown until program release (Oct–Nov 2026); all numbers are speculative until then. Italicized Result entries are pre-embargo / topline-only.
| Trial | Sponsor | Indication | Phase | Endpoint | Result (pre-embargo) | Expected status | Practice-changing? |
|---|---|---|---|---|---|---|---|
| monarchE 7-yr | Lilly | HR+/HER2- high-risk EBC adjuvant (abemaciclib + ET) | 3 | iDFS / OS | Prior 5-yr iDFS HR 0.68; 7-yr OS the watched endpoint | expected, GS slot likely | Strengthens / confirms adjuvant SOC if OS HR <0.85 |
| NATALEE long-term | Novartis | HR+/HER2- stage II–III EBC adjuvant (ribociclib + ET) | 3 | iDFS / OS | Prior iDFS HR 0.749; OS pending | expected, GS slot likely | Practice-changing — extends CDK4/6 adjuvant to stage II; competes with monarchE on tolerability |
| DESTINY-Breast09 | Daiichi Sankyo / AZ | HER2+ 1L MBC (T-DXd ± pertuzumab vs THP) | 3 | PFS | PFS positive per AZ/Daiichi topline; magnitude TBD | expected, GS01 / late-breaker | Yes — would displace THP as 1L HER2+ SOC |
| DESTINY-Breast05 | Daiichi Sankyo / AZ | HER2+ high-risk residual disease post-neoadj (T-DXd vs T-DM1) | 3 | iDFS | expected, subject to embargo | anticipated | Yes if positive — displaces T-DM1 in KATHERINE niche |
| DESTINY-Breast11 | Daiichi Sankyo / AZ | HER2+ high-risk EBC neoadj (T-DXd → THP vs ddAC-THP) | 3 | pCR / EFS | expected, subject to embargo | anticipated; may slip to 2027 | Practice-changing if pCR meaningfully higher |
| DESTINY-Breast12 update | Daiichi Sankyo / AZ | HER2+ MBC with active/stable brain mets (T-DXd) | 3b | CNS-PFS / OS | Prior CNS-ORR ~80% at SABCS 2024 / ESMO 2025 | expected update | Confirmatory; brain-mets framing |
| EMBER-3 update | Lilly | 2L ER+/HER2- MBC, ESR1-mut and wild-type (imlunestrant ± abema) | 3 | PFS | Prior PFS positive in ESR1-mut subgroup | expected mature OS | Class-defining for next-gen oral SERDs |
| persevERA OS | Roche/Genentech | 1L ER+/HER2- MBC (giredestrant + palbo vs letrozole + palbo) | 3 | OS (sec) | PFS missed primary per Roche Mar 2026; OS context-setting | expected secondary readout | Preserves CDK4/6 + AI SOC; confirms SERD-monotherapy ceiling |
| EMBER-4 | Lilly | HR+/HER2- EBC adjuvant (imlunestrant vs ET SOC, post-monarchE strata) | 3 | iDFS | Enrolling; readout not expected at SABCS 2026 | ongoing-trial poster only | Future readout — 2027/28 |
| VERITAC-2 | Arvinas / Pfizer | 2L/3L ER+/HER2- MBC, ESR1-mut (vepdegestrant PROTAC) | 3 | PFS | PFS positive in ESR1-mut subgroup per AACR 2025 / SABCS 2024 | expected mature data / OS update | Class-validating for ER-targeted PROTAC |
| postMONARCH update | Lilly | 2L HR+/HER2- MBC post-CDK4/6 (abema + fulv vs fulv) | 3 | PFS | Prior PFS HR 0.73; mature OS the watch | expected update | Strengthens post-CDK4/6 sequencing |
| KEYNOTE-756 follow-up | MSD | HR+/HER2- high-risk EBC neoadj (pembro + chemo neoadj → pembro + ET adj) | 3 | EFS / OS | pCR positive at SABCS 2023; EFS the practice-changing endpoint | expected, GS slot | Yes if EFS positive — extends pembro to HR+ EBC |
| CheckMate 7FL follow-up | BMS | HR+/HER2- high-risk EBC neoadj (nivo + chemo) | 3 | EFS | pCR positive at SABCS 2023 | expected EFS update | Confirmatory PD-1 + chemo neoadj in HR+ EBC |
| A-BRAVE final | Cooperative (Italy) | TNBC post-neoadj residual disease (avelumab adjuvant) | 3 | DFS | Prior DFS marginal | expected mature data | Marginal — likely subgroup-driven |
| OptimICE-RD / NRG-BR009 | NRG / cooperative | TNBC residual disease post-neoadj (pembro + cape vs pembro alone) | 3 | iDFS | enrolling/maturing; readout window plausible 2026–27 | anticipated | Post-KEYNOTE-522 adjuvant intensification question |
| ASCENT-04 PFS2 / OS update | Gilead | 1L PD-L1+ MBC TNBC (sacituzumab + pembro) | 3 | PFS2 / OS | PFS1 positive at ASCO 2026 LBA1000 | expected confirmatory | Confirmatory TROP2-ADC durability |
| ASCENT-03 | Gilead | 1L PD-L1- MBC TNBC (sacituzumab vs chemo) | 3 | PFS | Sacituzumab + pembro precedent; PD-L1- subset | expected | Potential 1L TNBC niche extension |
| TROPiCS-02 long-term | Gilead | 2L+ HR+/HER2- MBC (sacituzumab) | 3 | OS update | Prior PFS / OS positive | expected mature data | Strengthens TROP2-ADC in HR+ post-endocrine |
| TROPION-Breast01 / -02 | Daiichi / AZ | HR+/HER2- and TNBC MBC (datopotamab deruxtecan) | 3 | PFS / OS | Prior PFS positive HR+; TNBC data evolving | expected updates | Class competition with sacituzumab |
| CAPItello-291 follow-up | AZ | 2L HR+/HER2- MBC (capivasertib + fulv, AKT pathway-altered subset) | 3 | OS | PFS positive; OS the watched endpoint | expected mature data | Confirms AKT-i in PIK3CA/AKT1/PTEN-altered subset |
| INAVO120 / INAVO121 | Roche/Genentech | 1L/2L HR+/HER2- PIK3CA-mut MBC (inavolisib combos) | 3 | PFS / OS | INAVO120 PFS HR 0.43 at SABCS 2023; OS now the watch | expected update | Strengthens 1L PIK3CA-mut combo |
| HER2CLIMB-05 / HER2CLIMB-02 update | Pfizer / Seagen | HER2+ MBC and brain mets (tucatinib combinations) | 3 | PFS / CNS-PFS | Prior HER2CLIMB positive | expected ongoing-trial or update | Sequencing question vs T-DXd |
| DARE / LEADER / c-TRAK-TN ctDNA updates | Cooperative / academic | ctDNA-MRD-guided adjuvant decisions, HR+/HER2- and TNBC | 2/3 | RFS / intervention triggering | Signal-finding; not practice-changing yet | expected updates | Sets up ctDNA-MRD adjuvant guideline path |
| POSITIVE follow-up | IBCSG / cooperative | HR+ EBC fertility / pregnancy interruption of ET | observational/randomized | BCFI / disease events | Original GS4 2022; 3-yr safety positive; longer follow-up the question | expected update | Strengthens shared decision-making for young patients |
| HER2-ultralow analyses | Multiple | Assay standardization for HER2-low/-ultralow IHC; T-DXd eligibility | analytic / correlative | concordance / outcome | Pathology standardization theme | expected mini-symposium | Sets the eligible-population denominator for ADC SOC |
Additional shortlist candidates to stub once the program drops:
- Brain metastases: intrathecal T-DXd / tucatinib early-phase, leptomeningeal disease trials, novel BBB-penetrant HER2 / TROP2 conjugates.
- HER2+ de-escalation: PHERGain follow-up (chemo-free neoadj), CompassHER2 series.
- Early-phase / novel: CDK2-selective inhibitors, KAT6 / SMARCA2 degraders, AR-targeted in TNBC, oral GnRH antagonists (relugolix combinations).
- Health disparities / survivorship: GLP-1 in breast cancer obesity, racial disparities in ADC outcomes, cardiotoxicity in HER2 long-term survivors.
- Prevention: anastrozole / tamoxifen chemoprevention long-term follow-up, denosumab fracture / DFS follow-up.
Cross-cutting themes (for themes.md)¶
To synthesize across trials/ once populated:
- HER2+ 1L SOC reset. DESTINY-Breast09 vs THP — if PFS magnitude is large, the entire HER2+ 1L paradigm shifts to T-DXd-first. Echoes the DESTINY-Breast03 2L reset of 2021.
- CDK4/6 adjuvant battle: monarchE vs NATALEE. 7-yr OS for abemaciclib + the maturing NATALEE OS define which agent (and which patient subset, II vs III high-risk) wins the adjuvant niche.
- Next-gen oral SERDs — class definition. EMBER-3, persevERA, VERITAC-2, plus ELAINE/ARV-471 — does any oral SERD beat the CDK4/6 + AI 1L SOC, or do they stay 2L+/ESR1-mut?
- Post-CDK4/6 sequencing. postMONARCH, INAVO121, CAPItello-291 OS — the field has multiple second-line options; SABCS 2026 will start to rank them by subset (PIK3CA, AKT, ESR1, wild-type).
- TROP2-ADC class. Sacituzumab govitecan vs datopotamab deruxtecan — cross-trial PFS / OS / tolerability comparisons in HR+ and TNBC.
- ctDNA-MRD adjuvant decision-making. DARE / LEADER / c-TRAK-TN — moving from signal-finding to randomized intervention. The FDA / NCCN posture watch.
- Brain-metastasis activity as a class differentiator. T-DXd (DB-12), tucatinib (HER2CLIMB), intrathecal regimens — the ADC + small-molecule brain-mets data is becoming a category for label / guideline differentiation.
- Neoadjuvant IO in HR+ EBC. KEYNOTE-756 EFS, CheckMate 7FL EFS — does pembro / nivo extend from TNBC (KEYNOTE-522 SOC) into HR+ high-risk EBC?
- Pregnancy / fertility / survivorship. POSITIVE long-term — the practice-changing data that made it OK to pause ET; longer follow-up tests durability.