💭How do we approach 1L HER2+ MBC in the context of HER2CLIMB05, DB-09, & PATINA?
🔍 Tune into #TumorBoardTuesday 12/16 where we discuss!
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#TumorBoardTuesday
This was a mountain of data to cover in a very fast moving treatment area - thank you so much @drgattimays.bsky.social and @KennaKoehler for this massive effort🙏
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#PostTest Q2️⃣ #TumorBoardTuesday
🧐A 75yo♀️w/ ER+/HER2- PIK3CA+ mBC starts 2L Tx w/alpelisib + fulvestrant. Baseline A1C = 6.1 & BMI = 33. What steps can limit risk for severe hyperglycemia❓
1) Labs QW x 2, then Qmonth
2) Baseline A1C, then Q3 months
3) Consider metformin premed
4) All of the above
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#PostTest Q1️⃣ #TumorBoardTuesday
🤔What 2L Tx would you offer a 45yo♀️w/ ER+/HER2- mBC and an AKT mutation on 🧪liquid biopsy after progression at cycle 47 of ribociclib ➕ AI/OFS❓
1) Capecitabine monotherapy
2) Capivasertib + fulvestrant
3) Elacestrant monotherapy
4) Everolimus + fulvestrant
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18/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 12🏫
🔊Take home points 🔊:
✅ 🩸Bx recommended at⬆️ on 1L to screen for🧬mutations
✅ 2L options: mPFS 5-11 mos, some with⬆️OS
✅ Optimal sequence unknown, likely depends in part on patient factors
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17/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 11🏫
Ongoing HR+/HER2- trials:
2️⃣ TroFuse-011 (NCT06841354)
💊 Sacituzumab tirumotecan vs physician’s choice chemo
💉 Trop-2 directed ADC
👆 Primary endpoints: PFS and OS
www.clinicaltrials.gov/study/NCT068...
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17/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 11🏫
Ongoing HR+/HER2- trials:
1️⃣ HERTHENA-Breast04 (NCT07060807)
💊 Patritumab deruxtecan (HER3-DXd) vs physician’s choice chemo
💉 ADC of HER3 mAb linked to topoisomerase I payload
👆Primary endpoints: PFS and OS
www.clinicaltrials.gov/study/NCT068...
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16/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 10🏫
DESTINY-Breast04
⬆️ mPFS 10.1 months in ER+/HER-low with T-DXd vs mPFS 5.4 doc’s choice
⬆️ mOS 23.9mon in ER+/HER2-low vs mOS 17.5 doc’s choice
📎https://www.nejm.org/doi/full/10.1056/NEJMoa2203690
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16/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 10🏫
DESTINY-Breast04
👩🦳 2L mBC HER2- low
✅ Both ER+ and ER-; HER2-low
➡️IHC1+ = 58% & IHC2+ = 42%
💊 Trastuzumab deruxtecan (T-DXd) v physician’s choice (Cape, eribulin, Gem, paclitaxel or nab-paclitaxel)
💊 T-DXd: ADC of humanized anti-HER2 mAb🔗to topo I⛔
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15/18 #TumorBoardTuesday
What is HER2 low mBC❓
👉 HER2 IHC 1+ or IHC 2+ with ⛔FISH
🔬Recent review➡️among all Pts 35% are HER2-low
🔎HR+ Pts, 40% are HER2-low
🔎HR- Pts, 23% are HER2-low
🚫Clinical data suggest probably not a separate clinical subtype but data is immature
📎 www.nejm.org/doi/full/10....
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15/18 #TumorBoardTuesday
⏭️ Moving on to Case 3…
#TumorBoardTuesday #OncTwitter Case 3
👩🦳 67 y.o. postmenopausal female
💉 Metastatic HR+, “HER2 low” BC to bone, liver
💊 Progressed on 1L CDK4/6i + ET within 4 months of starting therapy
🧪 No BRCA mutations
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14/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 9🏫
evERA study
🥇 Reported that evERA met primary endpoint of PFS in ITT and ESR1 mutated patients
🔊 To be presented at upcoming meeting - #StayTuned
📎ascopubs.org/doi/pdf/10.1200/JCO.2023...
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14/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 9🏫
📰 Breaking news! 🔊 evERA study
🔎 Phase III, randomized trial (NCT05306340)
👩🦳 mBC HR+/HER2-
✅ Previous tx w/CDK4/6i+ET
💊 Giredestrant (30 mg QD) + Evero vs Exemestane/Evero
💊 Giredestrant: A novel, nonsteroidal oral SERD 🚫 NOT FDA approved as of today
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#PostTest Q1️⃣ #TumorBoardTuesday
👉🏽#CME Eval 🔗 integrityce.com/TBTeval24
👉🏽ALL CME🔗 integrityce.com/TBT2024
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13/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 8🏫
PrE0102
💉Fulvestrant+💊Everolimus vs Fulvestrant/Placebo
⬆️ mPFS 10.3 months fulvestrant + everolimus vs 5.1 fulvestrant alone
👄 Mucositis common → steroid mouth rinse (SWISH study for prophylaxis)
📎https://pubmed.ncbi.nlm.nih.gov/29664714/
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13/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 8🏫
PrE0102: An oldie by a goodie
👩🦳 2L metastatic AI-resistant, HR+/HER2-
✅ Prior ET and < 1 chemo
💉 Fulvestrant + 💊 Everolimus (10mg daily; mTOR inhibtor) vs Fulvestrant/Placebo
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18/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 12🏫
🔊Take home points 🔊:
✅ Liquid biopsy recommended at progression on 1L to screen for mutations
✅ 2L options have mPFS 5-11 months, some with OS benefit
✅ Optimal sequence unknown at this time, likely depends in part on patient factors
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11/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 6🏫
EMERALD
👩🦳2L metastatic HR+/HER2- received 💊 Elacestrant 400mg daily vs 💉fulvestrant or 💊AI
🤢 Most common AE: nausea and vomiting
📎ascopubs.org/doi/10.1200/JCO.22.00338
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12/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 7🏫
EMBER-3
⬆️ PFS in ESR1m→ 5.5 mon Imlunestrant vs 3.8 mon ET SOC vs 9.4 mon Imlunestrant + Abemaciclib
❓🙋FDA Approved Sept 2025 Imlunestrant monotherapy ONLY [combination not submitted to FDA]
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12/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 7🏫
EMBER-3
👩🦳 2L me HR+/HER2-
💊 Imlunestrant, next gen oral SERD with 🧠CNS activity
✅ 1-2 prior ET+/-CDK4/6i [recurrence <12mo or on adj CDK4/6i/AI or PD on 1L CDK4/6i/ET]
📝 💊 Imlunestrant 400mg QD vs 💊SOC [fulvestrant or exemestane] vs💊 Imlunestrant+Abema
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#tumorboardtuesday
🤔Hmmm....much more rapid disease progression on the CDK4/6🚫+AI - does this portend for a worse prognosis in subsequent lines of therapy❓
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17/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 11🏫
Ongoing trials in the HR+/HER2- space…
1️⃣ HERTHENA-Breast04 (NCT07060807)
💊 Patritumab deruxtecan (HER3-DXd) vs physician’s choice chemo
💉 ADC of HER3 mAb linked to topoisomerase I payload
👆Primary endpoints: PFS and OS
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16/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 10🏫
DESTINY-Breast04
👩🦳 2L metastatic HER2- low BC
✅ Included both ER+ and ER-; HER2-low breakdown: IHC1+ = 58% and IHC2+ = 42%
💊 Trastuzumab deruxtecan (T-DXd) vs physician’s choice chemo (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel)
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11/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 6🏫
⬆️ Elacestrant benefited all subgroups including: 🦴only, 🫁 visceral mets, > 3 mets
⬆️ Elacestrant benefited all🧬subgroups: ✔️ESR1+PIK3CA, ✔️ESR1+TP53, ✔️ESR1+HER2-low
🤢 Most common AE: N/V
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11/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 6🏫
EMERALD
👩🦳 2L metastatic HR+/HER2- received 💊 Elacestrant, an oral selective ER Degrader (SERD)
✅ 1-2 prior ET including CDK4/6i and < 1 chemo
💊 Elacestrant 400mg daily vs 💉fulvestrant or 💊AI
⬆️⬆️ PFS for prior💊 CDK4/6i > 12 mon with ESR1 mutated tumors
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15/18 #TumorBoardTuesday
⏭️ Moving on to Case 3…
#TumorBoardTuesday #OncTwitter Case 3
👩🦳 67 y.o. postmenopausal female
💉 Metastatic HR+, “HER2 low” BC to bone, liver
💊 Progressed on 1L CDK4/6i + ET within 4 months of starting therapy
🧪 No BRCA mutations
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10/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 5🏫
👉 Recurred on adjuvant endocrine tx
👉 Recurred <2y after adjuvant endocrine tx
👉 ⬆️Dz<6mos of starting 1L mBC tx
👉 ⬆️Dz after any duration of >=2nd line of ET-based therapy
👉 Known ESR1 mutation [now have 2 Rx for ESR1m → elacestrant or imlunestrant]
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10/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 5🏫
🤔When is a patient considered to be “endocrine resistant”?
Per Advanced Breast Cancer International Consensus Guidelines,
Link to Guidelines: www.thebreastonline.com/article/S096...
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14/18 #TumorBoardTuesday
👩🏻🏫Mini Tweetorial 9🏫
📰 Breaking news! 🔊 evERA study (#ESMO2025)
🔎 Phase III, randomized trial (NCT05306340)
👩🦳 Metastatic HR+/HER2-
✅ Previous tx w/ CDK4/6i + ET
💊 Giredestrant is a novel, nonsteroidal oral SERD 🚫 NOT FDA approved as of today
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9/18 #TumorBoardTuesday
⏭️ Case 2
#TumorBoardTuesday #OncTwitter Case 2
👩🦳 62 y.o. postmenopausal female
💉 mBC to the🫁, ER 70%, PR 85%, HER2⛔[IHC 1] 🩻 confirmed⬆️Dz on 1L ribo/letrozole at C7
🏃♀️ ECOG PS 1. No co-morbidities.
⛔ Normal vital signs, labs
🩸Liquid Biopsy shows ESR1 mutation, TMB-High
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