OpenOnco · Treatment Plan

Treatment plan — Invasive breast cancer

PLAN-BREAST-HR-2L-HER2LOW-001-V1 · v1 · 2026-05-13

Patient

BREAST-HR-2L-HER2LOW-001 · Algorithm: ALGO-BREAST-HR-POS-2L

DiagnosisInvasive breast cancer

MOH / ICD-10C50

ICD-O-38500/3; C50.9

StageIV

Histologyinvasive_ductal_carcinoma_NST

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks

✅ Covered biomarkers (matched in KB)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
BIO-HER2-LOW	IHC 1+ OR IHC 2+/ISH-negative (HER2-low by ASCO/CAP 2023 criteria)	IA	Standard care SRC-DESTINY-BREAST04-MODI-2022: Level A (Supports, Sensitivity/Response) SRC-NCCN-BREAST-2025: Level Category 1 (Supports, Sensitivity/Response) SRC-ESMO-BREAST-METASTATIC-2024: Level A (Supports, Sensitivity/Response)	Trastuzumab deruxtecan (T-DXd, DS-8201) is FDA-approved (Aug 2022) for unresectable or metastatic HER2-low (IHC 1+ or 2+/ISH-) breast cancer following prior chemotherapy. DESTINY-Breast04 (Modi et al. NEJM 2022): HR+/HER2-low — mPFS 10.1 vs 5.4 mo (HR 0.49, p<0.001); mOS 23.9 vs 17.5 mo (HR 0.64, p=0.003). HR-/HER2-low (TNBC subgroup) — mOS 18.2 vs 8.3 mo. DESTINY-Breast06 (Curigliano et al. NEJM 2024) extended indication to HER2-low and HER2-ultralow (IHC 0 with incomplete staining) HR+/HER2- endocrine-pretreated patients — mPFS 13.2 vs 8.1 mo (HR 0.62, p<0.001). T-DXd dose: 5.4 mg/kg IV q3w. Key safety: interstitial lung disease (ILD) / pneumonitis ~12% (grade ≥3 ~3%) — mandatory baseline CT and monitoring per NCCN/ESMO. HER2-low reclassification affects ~60% of previously HER2-negative metastatic breast cancer patients — large population impact.	trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV q3w monotherapy (post-chemotherapy; DESTINY-Breast04) trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV q3w monotherapy (post-endocrine HR+ disease; DESTINY-Breast06)	SRC-NCCN-BREAST-2025 SRC-ESMO-BREAST-METASTATIC-2024 SRC-DESTINY-BREAST04-MODI-2022

⚠️ Not included in plan

Biomarker	Status
BIO-ER	Not in KB — ask clinician to verify
BIO-PR	Not in KB — ask clinician to verify

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW

Regimen

T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic)

Drugs + NSZU

Trastuzumab deruxtecan (T-DXd) (DRUG-TRASTUZUMAB-DERUXTECAN) 5.4 mg/kg IV · Day 1 of 21-day cycle, continuous until progression · IV ✓ NSZU covered

Supportive care

SUP-BONE-HEALTH-PROSTATE

Reason

Primary current-line option selected by ALGO-BREAST-HR-POS-2L at step 4.

Other current-line alternatives (5 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Standard plan

Indication

IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB

Regimen

Alpelisib + fulvestrant (HR+/HER2- PIK3CA-mutant metastatic post-AI/CDK4/6i)

Drugs + NSZU

Alpelisib (DRUG-ALPELISIB) 300 mg PO once daily with food · Continuous, no off-day · PO ⚠ Out-of-pocket
Fulvestrant (DRUG-FULVESTRANT) 500 mg IM days 1, 15, 29, then monthly · Loading days 1, 15, 29; then q4w maintenance · IM ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB

Regimen

Capivasertib + fulvestrant (HR+/HER2- PIK3CA/AKT1/PTEN-altered metastatic post-AI/CDK4/6i)

Drugs + NSZU

Capivasertib (DRUG-CAPIVASERTIB) 400 mg PO BID, 4 days on / 3 days off (intermittent schedule) · Days 1-4, 8-11, 15-18, 22-25 of 28-day cycle · PO ✗ Not registered in UA
Fulvestrant (DRUG-FULVESTRANT) 500 mg IM days 1, 15, 29, then monthly · Loading days 1, 15, 29; then q4w maintenance · IM ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT

Regimen

Elacestrant monotherapy (HR+/HER2- ESR1-mutant metastatic post-AI/CDK4/6i)

Drugs + NSZU

Elacestrant (DRUG-ELACESTRANT) 345 mg PO once daily with food · Continuous, no off-day · PO ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS

Regimen

Fulvestrant + everolimus (HR+/HER2- metastatic post-AI/CDK4/6i, no targetable mutation)

Drugs + NSZU

Fulvestrant (DRUG-FULVESTRANT) 500 mg IM days 1, 15, 29, then monthly · Loading days 1, 15, 29; then q4w maintenance · IM ✓ NSZU covered
Everolimus (DRUG-EVEROLIMUS) 10 mg PO once daily continuous · Continuous, no off-day · PO ⚠ Out-of-pocket

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-BRCA-MET-TALAZOPARIB

Regimen

Talazoparib monotherapy (gBRCA-mutant HER2- locally advanced or metastatic breast)

Drugs + NSZU

Talazoparib (DRUG-TALAZOPARIB) 1 mg PO once daily continuous · Continuous, no off-day; reduce to 0.75 / 0.5 / 0.25 mg for AE management · PO ⚠ Out-of-pocket

Reason

Current-line alternative presented for HCP consideration

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.

Step 3 → branch 4

RF-BREAST-HER2-LOW-ACTIONABLE ★ winner: HER2-low breast cancer (IHC 1+ OR IHC 2+ with non-amplified ISH) — ~50-55% of HER2-non-positive breast cancers. T-DXd 2L+ approved in HR+ and TNBC HER2-low post-chemo (DESTINY-Breast04 — mPFS 9.9 vs 5.1 mo, OS 23.4 vs 16.8 mo). SRC-NCCN-BREAST-2025SRC-ESMO-BREAST-METASTATIC-2024SRC-DESTINY-BREAST04-MODI-2022

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Where to order	Needed for
TEST-CECT-CAP	CECT chest/abdomen/pelvis	Critical	imaging	—	all tracks
TEST-ER-PR-IHC	ER + PR immunohistochemistry on tumor	Critical	—	CSD Lab ✓ (code TBC)	all tracks
TEST-HER2-IHC-FISH	HER2 IHC + reflex FISH on tumor	Critical	—	CSD Lab ✓ (code TBC)	all tracks
TEST-GERMLINE-BRCA-PANEL	Germline BRCA1/2 + HRR panel sequencing	Standard	—	CSD Lab: M089	all tracks
TEST-PIK3CA-NGS	PIK3CA mutation testing (tumor or ctDNA)	Standard	—	CSD Lab: M065	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

AKT1 E17K activating hotspot specifically positioning capivasertib + fulvestrant in HR+/HER2- metastatic breast post-endocrine ± CDK4/6i. CAPItello-291 (Turner 2023) enrolled patients with PIK3CA / AKT1 / PTEN-altered tumors; AKT1 E17K accounted for ~7% of the altered cohort. Capivasertib + fulvestrant mPFS 7.3 vs 3.1 mo (HR 0.50, p<0.001) in the altered population. AKT1 E17K is the dominant (>90%) AKT1 hotspot. Candidate RF specifically anchors the E17K → capivasertib pairing distinct from the broader RF-BREAST-AKT1-E17K-ACTIONABLE. RF-BREAST-AKT1-E17K-CAPIVASERTIB-CANDIDATE
HBV/HCV/HIV serology + dental evaluation pre-bisphosphonate/denosumab + DPYD genotyping for capecitabine-containing regimens (EU practice).RF-BREAST-INFECTION-SCREENING
PIK3CA-mutant HR+/HER2- metastatic breast with co-alteration profile (endocrine-resistant biology — relapse on / within 12 months of adjuvant endocrine therapy OR de novo metastatic with rapid progression). INAVO120 (Jhaveri 2024) randomized first-line endocrine-resistant PIK3CA-mut HR+/HER2- MBC to inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant (mPFS 15.0 vs 7.3 mo, HR 0.43, p<0.0001). Inavolisib is a next-gen PI3Kα-selective + mutant-specific degrader with reduced hyperglycemia vs alpelisib. Candidate RF positions the 1L INAVO120 triplet specifically — distinct from RF-BREAST-PIK3CA-MUT-ACTIONABLE (broad 2L+ pathway-altered class). RF-BREAST-PIK3CA-COALT-INAVOLISIB-CANDIDATE

CONTRA-AGGRESSIVE

Hard contraindications to escalation

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic)

21-day cycles × Continuous until progression or unacceptable toxicity

Standard plan

Induction · Alpelisib + fulvestrant (HR+/HER2- PIK3CA-mutant metastatic post-AI/CDK4/6i)

28-day cycles × Continuous until progression or unacceptable toxicity

Standard plan

Induction · Capivasertib + fulvestrant (HR+/HER2- PIK3CA/AKT1/PTEN-altered metastatic post-AI/CDK4/6i)

28-day cycles × Continuous until progression or unacceptable toxicity

Standard plan

Induction · Elacestrant monotherapy (HR+/HER2- ESR1-mutant metastatic post-AI/CDK4/6i)

28-day cycles × Continuous until progression or unacceptable toxicity

Standard plan

Induction · Fulvestrant + everolimus (HR+/HER2- metastatic post-AI/CDK4/6i, no targetable mutation)

28-day cycles × Continuous until progression or unacceptable toxicity

Standard plan

Induction · Talazoparib monotherapy (gBRCA-mutant HER2- locally advanced or metastatic breast)

28-day cycles × Continuous until progression or unacceptable toxicity

MDT brief

Discussion questions (5, 1 blocking)

BLOCKING OQ-BIOMARKER-ESTROGEN-RECEPTOR
What is the status of Estrogen receptor (ER) (BIO-ESTROGEN-RECEPTOR)? It is required by track(s): IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW, IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB, IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB, IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT, IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS, IND-BREAST-BRCA-MET-TALAZOPARIB. Expected value: positive.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ pathologist
OQ-BIOMARKER-AKT1
What is the status of AKT1 E17K mutation (BIO-AKT1)? It is required by track(s): IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB. Expected value: E17K mutation.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist
OQ-BIOMARKER-BRCA1-BRCA2-GERMLINE
What is the status of BRCA1/BRCA2 germline pathogenic variant (BIO-BRCA1-BRCA2-GERMLINE)? It is required by track(s): IND-BREAST-BRCA-MET-TALAZOPARIB. Expected value: pathogenic OR likely-pathogenic germline variant.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist
OQ-BIOMARKER-ESR1
What is the status of ESR1 mutation (ligand-binding domain) (BIO-ESR1)? It is required by track(s): IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT. Expected value: ligand-binding-domain mutation present (ctDNA preferred — D538G, Y537S, Y537N, Y537C, L536H, E380Q).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist
OQ-BIOMARKER-PTEN
What is the status of PTEN loss-of-function (BIO-PTEN)? It is required by track(s): IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB. Expected value: loss-of-function (biallelic NGS or complete IHC loss).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist

MDT talk tree (6 steps)

#	Owner	Topic	Action
1	pathologist	Biomarker status BLOCKING	What is the status of Estrogen receptor (ER) (BIO-ESTROGEN-RECEPTOR)? It is required by track(s): IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW, IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB, IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB, IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT, IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS, IND-BREAST-BRCA-MET-TALAZOPARIB. Expected value: positive.
2	molecular_geneticist	Biomarker status	What is the status of AKT1 E17K mutation (BIO-AKT1)? It is required by track(s): IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB. Expected value: E17K mutation.
3	molecular_geneticist	Biomarker status	What is the status of BRCA1/BRCA2 germline pathogenic variant (BIO-BRCA1-BRCA2-GERMLINE)? It is required by track(s): IND-BREAST-BRCA-MET-TALAZOPARIB. Expected value: pathogenic OR likely-pathogenic germline variant.
4	molecular_geneticist	Biomarker status	What is the status of ESR1 mutation (ligand-binding domain) (BIO-ESR1)? It is required by track(s): IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT. Expected value: ligand-binding-domain mutation present (ctDNA preferred — D538G, Y537S, Y537N, Y537C, L536H, E380Q).
5	molecular_geneticist	Biomarker status	What is the status of PTEN loss-of-function (BIO-PTEN)? It is required by track(s): IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB. Expected value: loss-of-function (biallelic NGS or complete IHC loss).
6	social_worker_case_manager	Specialist review	Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed.

Skills (recommended) — for consideration (2)

Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
Owns: OQ-BIOMARKER-AKT1, OQ-BIOMARKER-BRCA1-BRCA2-GERMLINE, OQ-BIOMARKER-ESR1, OQ-BIOMARKER-PTEN
Social worker / case manager recommended
Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed.

Data quality

Incomplete for default-track review. Default-track review is incomplete until required biomarker gaps are resolved.

Biomarker coverage: 2/7 known (29%), 5 missing, 1 default-track gaps
Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-BREAST-AKT1-E17K-ACTIONABLE, RF-BREAST-AKT1-E17K-CAPIVASERTIB-CANDIDATE, RF-BREAST-BRCA-GERMLINE-ACTIONABLE, RF-BREAST-CDH1-LOBULAR-CANDIDATE, RF-BREAST-EARLY-STAGE, RF-BREAST-ESR1-MUT-ACTIONABLE, RF-BREAST-ESR1-Y537S-D538G-CANDIDATE, RF-BREAST-FRAILTY-AGE, RF-BREAST-HER2-AMP-ACTIONABLE, RF-BREAST-HER2-LOW-ACTIONABLE, RF-BREAST-HER2-ULTRALOW-CANDIDATE, RF-BREAST-HIGH-RISK-BIOLOGY, RF-BREAST-INFECTION-SCREENING, RF-BREAST-ORGAN-DYSFUNCTION, RF-BREAST-OVARIAN-HRD-ASSAY-DISTINCTION, RF-BREAST-PIK3CA-COALT-INAVOLISIB-CANDIDATE, RF-BREAST-PIK3CA-MUT-ACTIONABLE, RF-BREAST-STAGE-IV-METASTATIC, RF-BREAST-TNBC, RF-BREAST-TRANSFORMATION-PROGRESSION, RF-PAN-ATM-CHEK2-CDK12-PARPI-CANDIDATE, RF-PAN-BRCA-SOMATIC-PARPI-CANDIDATE, RF-PAN-PALB2-PARPI-CANDIDATE

Missing biomarker	Label	MDT owner	Default track	Required by	Next action
`BIO-ESTROGEN-RECEPTOR`	Estrogen receptor (ER)	pathologist	yes	IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW, IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB, IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB, IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT, IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS, IND-BREAST-BRCA-MET-TALAZOPARIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive
`BIO-AKT1`	AKT1 E17K mutation	molecular_geneticist	no	IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: E17K mutation
`BIO-BRCA1-BRCA2-GERMLINE`	BRCA1/BRCA2 germline pathogenic variant	molecular_geneticist	no	IND-BREAST-BRCA-MET-TALAZOPARIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: pathogenic OR likely-pathogenic germline variant
`BIO-ESR1`	ESR1 mutation (ligand-binding domain)	molecular_geneticist	no	IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT	Verify result, method, specimen, and report date before sign-off. Expected/constraint: ligand-binding-domain mutation present (ctDNA preferred — D538G, Y537S, Y537N, Y537C, L536H, E380Q)
`BIO-PTEN`	PTEN loss-of-function	molecular_geneticist	no	IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: loss-of-function (biallelic NGS or complete IHC loss)

Technical MDT skill metadata (2/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-BOLERO2-BASELGA-2012: Everolimus in Postmenopausal Hormone-Receptor-Positive Advanced Breast Cancer (2012)
SRC-CAPITELLO291-TURNER-2023: Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer (2023)
SRC-DESTINY-BREAST04-MODI-2022: Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer (2022)
SRC-EMBRACA-LITTON-2018: Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation (2018)
SRC-EMERALD-BIDARD-2022: Elacestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer: Results from the Randomized Phase III EMERALD Trial (2022)
SRC-ESMO-BREAST-METASTATIC-2024: ESMO Clinical Practice Guideline on Metastatic Breast Cancer (2024)
SRC-NCCN-BREAST-2025: NCCN Clinical Practice Guidelines — Breast Cancer (2025.v4)
SRC-SOLAR1-ANDRE-2019: Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer (2019)

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT05607004	(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer	PHASE2	RECRUITING	Atossa Therapeutics, Inc.	—	Biomarker: enriched Surrogate endpoint only Single country
NCT06067503	Biomarkers to Detect Endocrine Therapy Resistance	PHASE2	RECRUITING	University of Wisconsin, Madison	—	Biomarker: enriched Small N (<50) Single country
NCT06763328	Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy	PHASE3	RECRUITING	City of Hope Medical Center	—	Biomarker: enriched Single country
NCT04660435	To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer	N/A	RECRUITING	Fondazione Sandro Pitigliani	—	Biomarker: enriched Surrogate endpoint only Single country
NCT06666439	Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer	N/A	RECRUITING	Julia Foldi	—	Biomarker: enriched Small N (<50) Single country
NCT04383275	Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS)	PHASE2	RECRUITING	Fudan University	—	Biomarker: enriched Surrogate endpoint only Single country
NCT04230109	Sacituzumab Govitecan In TNBC	PHASE2	RECRUITING	Massachusetts General Hospital	—	Biomarker: enriched Single country
NCT06092892	IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases	PHASE2	RECRUITING	Alice Chung	—	Biomarker: enriched Small N (<50) Single country
NCT05059444	ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation	N/A	RECRUITING	Guardant Health, Inc.	—	Biomarker: enriched
NCT07483307	A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer	PHASE2	RECRUITING	Memorial Sloan Kettering Cancer Center	—	Biomarker: enriched Single country

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).

Option	UA registration	NSZU	Cost orientation	Access pathway
Standard plan T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic) (REG-TDXD-METASTATIC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Alpelisib + fulvestrant (HR+/HER2- PIK3CA-mutant metastatic post-AI/CDK4/6i) (REG-ALPELISIB-FULVESTRANT-BREAST) 1/2 component drug(s) not on NSZU formulary	✓ registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Capivasertib + fulvestrant (HR+/HER2- PIK3CA/AKT1/PTEN-altered metastatic post-AI/CDK4/6i) (REG-CAPIVASERTIB-FULVESTRANT-BREAST) 1/2 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Elacestrant monotherapy (HR+/HER2- ESR1-mutant metastatic post-AI/CDK4/6i) (REG-ELACESTRANT-BREAST) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Fulvestrant + everolimus (HR+/HER2- metastatic post-AI/CDK4/6i, no targetable mutation) (REG-FULVESTRANT-EVEROLIMUS-BREAST) 1/2 component drug(s) not on NSZU formulary	✓ registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Talazoparib monotherapy (gBRCA-mutant HER2- locally advanced or metastatic breast) (REG-TALAZOPARIB-MONO-BREAST) 1/1 component drug(s) not on NSZU formulary	✓ registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT05607004 (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06067503 Biomarkers to Detect Endocrine Therapy Resistance No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06763328 Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04660435 To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06666439 Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04383275 Stage I HER2 Positive Invasive Breast Cancer De-escalation Study(IRIS) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04230109 Sacituzumab Govitecan In TNBC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06092892 IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05059444 ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07483307 A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-13.

plan_id: PLAN-BREAST-HR-2L-HER2LOW-001-V1 | version: 1 | generated: 2026-05-13T10:01:52.944292+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.