Patient
BREAST-HER2-EARLY-001 · Algorithm: ALGO-BREAST-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| 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
|
| Biomarker | Status |
|---|
| BIO-ER | Not in KB — ask clinician to verify |
| BIO-PR | Not in KB — ask clinician to verify |
Primary current-line option
- Indication
- IND-BREAST-HER2-POS-MET-1L-THP
- Regimen
- THP — docetaxel + trastuzumab + pertuzumab (HER2+ metastatic 1L)
- Drugs + NSZU
- Docetaxel (DRUG-DOCETAXEL) 75-100 mg/m² IV · Day 1 of 21-day cycle x 6-8 cycles, then HP maintenance · IV ✓ NSZU covered
- Trastuzumab (DRUG-TRASTUZUMAB) 8 mg/kg loading, 6 mg/kg maintenance IV · Day 1 of 21-day cycle, continuous until progression · IV ✓ NSZU covered
- Pertuzumab (DRUG-PERTUZUMAB) 840 mg loading, 420 mg maintenance 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-1L at step 2.
Other current-line alternatives (6 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-BREAST-HR-POS-EARLY-ADJ-CDK46I
- Regimen
- Abemaciclib adjuvant (HR+/HER2- early high-risk breast cancer)
- Drugs + NSZU
- Abemaciclib (DRUG-ABEMACICLIB) 150 mg PO BID · Continuous BID x 2 years (fixed duration) · PO ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB
- Regimen
- Ribociclib adjuvant + AI (HR+/HER2- early breast cancer; NATALEE)
- Drugs + NSZU
- Ribociclib (DRUG-RIBOCICLIB) 400 mg PO QD · Days 1-21 of each 28-day cycle (3 weeks on, 1 week off) · PO ⚠ NSZU — not for this indication
- Letrozole (DRUG-LETROZOLE) 2.5 mg PO QD · Continuous (or anastrozole 1 mg QD or exemestane 25 mg QD as alternatives) · PO ✓ NSZU covered
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-BREAST-HER2-POS-EARLY-NEOADJUVANT
- Regimen
- TCHP — docetaxel + carboplatin + trastuzumab + pertuzumab (HER2+ neoadjuvant)
- Drugs + NSZU
- Docetaxel (DRUG-DOCETAXEL) 75 mg/m² IV · Day 1 of 21-day cycle x 6 cycles · IV ✓ NSZU covered
- Carboplatin (DRUG-CARBOPLATIN) AUC 6 IV · Day 1 of 21-day cycle x 6 cycles · IV ⚠ NSZU — not for this indication
- Trastuzumab (DRUG-TRASTUZUMAB) 8 mg/kg IV loading, 6 mg/kg IV maintenance · Day 1 of 21-day cycle · IV ✓ NSZU covered
- Pertuzumab (DRUG-PERTUZUMAB) 840 mg IV loading, 420 mg IV maintenance · Day 1 of 21-day cycle · IV ✓ NSZU covered
- Supportive care
- SUP-BONE-HEALTH-PROSTATE, SUP-G-CSF-PRIMARY-PROPHYLAXIS-PROSTATE
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-BREAST-HER2-POS-MET-2L-TDXD
- 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
- Current-line alternative presented for HCP consideration
- Indication
- IND-BREAST-TNBC-EARLY-NEOADJUVANT
- Regimen
- Pembrolizumab + chemo (TNBC neoadjuvant)
- Drugs + NSZU
- Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3 weeks · Days 1 of cycles 1-8 (4 cycles each phase) · IV ⚠ NSZU — not for this indication
- Paclitaxel (DRUG-PACLITAXEL) 80 mg/m² IV weekly · Cycles 1-4 (12 weekly doses) · IV ✓ NSZU covered
- Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV · Cycles 1-4 q3 weeks (or weekly AUC 1.5) · IV ⚠ NSZU — not for this indication
- Doxorubicin (DRUG-DOXORUBICIN) 60 mg/m² IV · Cycles 5-8 q3 weeks · IV ✓ NSZU covered
- Cyclophosphamide (DRUG-CYCLOPHOSPHAMIDE) 600 mg/m² IV · Cycles 5-8 q3 weeks · IV ✓ NSZU covered
- Supportive care
- SUP-G-CSF-PRIMARY-PROPHYLAXIS-PROSTATE, SUP-BONE-HEALTH-PROSTATE
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO
- Regimen
- Pembrolizumab + chemotherapy (TNBC, metastatic PD-L1+)
- Drugs + NSZU
- Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV over 30 min · Day 1 q21d (when combined with paclitaxel or gem-carbo); or Day 1 q28d (when combined with nab-paclitaxel) · IV ⚠ NSZU — not for this indication
- 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 1 → branch 2
- RF-BREAST-HER2-AMP-ACTIONABLE ★ winner: HER2 amplification / overexpression in breast cancer (IHC 3+ OR IHC 2+ with ISH amplified) — ~15-20% of invasive breast. Defines HER2-positive treatment track: trastuzumab + pertuzumab + chemo (CLEOPATRA 1L), T-DXd 2L (DESTINY-Breast03 — mPFS 28.8 vs 6.8 mo vs T-DM1).
SRC-NCCN-BREAST-2025SRC-ESMO-BREAST-METASTATIC-2024SRC-DESTINY-BREAST03-CORTES-2022SRC-HER2CLIMB-MURTHY-2019
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| ID | Name | Priority | Category | Where to order | Needed for |
|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CECT-CAP | CECT chest/abdomen/pelvis | Critical | imaging | — | standard |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-ER-PR-IHC | ER + PR immunohistochemistry on tumor | Critical | — | CSD Lab ✓ (code TBC) | standard |
| TEST-HER2-IHC-FISH | HER2 IHC + reflex FISH on tumor | Critical | — | CSD Lab ✓ (code TBC) | standard |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-BONE-SCAN | Whole-body Tc-99m MDP bone scintigraphy | Standard | — | — | standard |
| TEST-CT-CAP | CT chest/abdomen/pelvis | Standard | imaging | — | standard |
| TEST-ECG | Electrocardiogram | Standard | clinical_assessment | — | aggressive |
| TEST-ECHO | Echocardiography | Standard | imaging | — | all tracks |
| TEST-GERMLINE-BRCA-PANEL | Germline BRCA1/2 + HRR panel sequencing | Standard | — | CSD Lab: M089 | standard |
| TEST-TSH | Thyroid-stimulating hormone | Standard | lab | — | standard |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- Age ≥75 + ECOG ≥2 + significant comorbidity — anthracycline + dose-dense regimens poorly tolerated; consider TC, weekly paclitaxel, single-agent endocrine, or trastuzumab + chemo of reduced intensity.RF-BREAST-FRAILTY-AGE
- HBV/HCV/HIV serology + dental evaluation pre-bisphosphonate/denosumab + DPYD genotyping for capecitabine-containing regimens (EU practice).RF-BREAST-INFECTION-SCREENING
- Cardiac dysfunction (LVEF <50%) — anthracycline + trastuzumab/pertuzumab + T-DM1/T-DXd all carry cardiotoxicity risk; baseline echo + serial monitoring required.RF-BREAST-ORGAN-DYSFUNCTION
- Somatic (tumor-only) BRCA1 or BRCA2 pathogenic variant identified on tumor NGS — pan-tumor PARPi-candidate signal. Disease applicability varies: ovarian (PAOLA-1, SOLO-1 — somatic BRCA pooled with germline in HRD-positive maintenance indication), mCRPC (PROfound cohort-A — olaparib mPFS 7.4 vs 3.6 mo, HR 0.34, somatic + germline pooled), pancreatic PDAC (POLO label is germline-only — somatic BRCA falls to off-label / NCCN "consider" tier), breast (OlympiAD / EMBRACA / OlympiA labels are germline-only — somatic BRCA breast remains investigational). Confirm somatic vs germline status via paired germline NGS before cascade-testing decisions (~40% of tumor-only "BRCA" calls are in fact germline per ASCO/CAP guidance).
RF-PAN-BRCA-SOMATIC-PARPI-CANDIDATE
CONTRA-AGGRESSIVE
Hard contraindications to escalation
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-BREAST-HR-POS-EARLY-ADJ-CDK46I)
- Do NOT use in pregnancy — CDK4/6i are teratogenic.
- Do NOT start until full surgical wound healing.
- Do NOT combine with strong CYP3A4 inhibitors — significant abemaciclib concentration increase.
- Do NOT skip CBC monitoring q2w first 2 months — severe neutropenia risk.
Aggressive plan (IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB)
- Do NOT use in pregnancy — CDK4/6i are teratogenic.
- Do NOT start if baseline QTcF >450 ms — ribociclib prolongs QT interval (boxed warning; fatal arrhythmia risk).
- Do NOT combine with strong CYP3A4 inhibitors (azole antifungals, clarithromycin, etc.) — significant ribociclib exposure increase.
- Do NOT skip ECG/QTc monitoring (baseline, Day 14 Cycle 1, periodic thereafter) — fatal arrhythmia risk.
- Do NOT use 600 mg dose adjuvantly — NATALEE protocol uses 400 mg; 600 mg is metastatic dosing only.
Standard plan (IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO)
- НІКОЛИ не призначати пембролізумаб при CPS <10 — відсутня OS перевага; тільки токсичnoсть
- Не призначати без тестування BRCA1/2 — BRCA-мутоваno пацієнти мають кращу відповідь на PARPi
- Не використовувати атезолізумаб при TNBC — FDA відкликала реєстрацію у серпno 2021
- Не застосовувати схему при стадії I-III (неоад'ювантnoй) — використовувати KEYNOTE-522 протокол
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Standard plan
Induction · THP — docetaxel + trastuzumab + pertuzumab (HER2+ metastatic 1L)
21-day cycles × Docetaxel × 6-8; HP continues until progression
Standard plan
Induction · Abemaciclib adjuvant (HR+/HER2- early high-risk breast cancer)
28-day cycles × 26 cycles (2 years fixed duration)
Aggressive plan
Induction · Ribociclib adjuvant + AI (HR+/HER2- early breast cancer; NATALEE)
28-day cycles × 36 cycles (3 years) for ribociclib; AI continues to 5 years
Standard plan
Induction · TCHP — docetaxel + carboplatin + trastuzumab + pertuzumab (HER2+ neoadjuvant)
21-day cycles × 6 (then surgery → adjuvant trastuzumab + pertuzumab to complete 1 year HER2-targeted therapy; T-DM1 if residual disease)
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 · Pembrolizumab + chemo (TNBC neoadjuvant)
21-day cycles × 8 (paclitaxel/carbo+pembro phase 1-4, then AC+pembro phase 5-8)
Standard plan
Induction · Pembrolizumab + chemotherapy (TNBC, metastatic PD-L1+)
28-day cycles × Pembrolizumab: up to 35 cycles (2 years) total or until progression/toxicity; chemo: typically 6-8 cycles then pembrolizumab maintenance
MDT brief
Discussion questions (3, 0 blocking)
OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist
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-EARLY-ADJ-CDK46I, IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB, IND-BREAST-TNBC-EARLY-NEOADJUVANT. Expected value: ER positive (>=1% by IHC).
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-PDL1-CPS
What is the status of PD-L1 Combined Positive Score (CPS) (BIO-PDL1-CPS)? It is required by track(s): IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO. Expected value: CPS ≥10 by 22C3 pharmDx — required for OS benefit per KEYNOTE-355.
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
MDT talk tree (4 steps)
| # | Owner | Topic | Action |
|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | pathologist | Biomarker status | What is the status of Estrogen receptor (ER) (BIO-ESTROGEN-RECEPTOR)? It is required by track(s): IND-BREAST-HR-POS-EARLY-ADJ-CDK46I, IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB, IND-BREAST-TNBC-EARLY-NEOADJUVANT. Expected value: ER positive (>=1% by IHC). |
| 3 | pathologist | Biomarker status | What is the status of PD-L1 Combined Positive Score (CPS) (BIO-PDL1-CPS)? It is required by track(s): IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO. Expected value: CPS ≥10 by 22C3 pharmDx — required for OS benefit per KEYNOTE-355. |
| 4 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
Skills (recommended) — for consideration (2)
- Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
- Pathologist (general) recommended
Confirm lymphoma histology + assess transformation risk (DLBCL/Richter).
Owns: OQ-BIOMARKER-ESTROGEN-RECEPTOR, OQ-BIOMARKER-PDL1-CPS
Data quality
Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.
- Biomarker coverage: 1/3 known (33%), 2 missing, 0 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-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 | no | IND-BREAST-HR-POS-EARLY-ADJ-CDK46I, IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB, IND-BREAST-TNBC-EARLY-NEOADJUVANT | Verify result, method, specimen, and report date before sign-off. Expected/constraint: ER positive (>=1% by IHC) |
BIO-PDL1-CPS | PD-L1 Combined Positive Score (CPS) | pathologist | no | IND-BREAST-TNBC-METASTATIC-1L-PEMBRO-CHEMO | Verify result, method, specimen, and report date before sign-off. Expected/constraint: CPS ≥10 by 22C3 pharmDx — required for OS benefit per KEYNOTE-355 |
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 | Sign-offs | Domain |
|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
Sources cited
- SRC-DESTINY-BREAST03-CORTES-2022: Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer (2022)
- SRC-ESMO-BREAST-EARLY-2024: ESMO Clinical Practice Guideline on Early Breast Cancer (2024)
- SRC-ESMO-BREAST-METASTATIC-2024: ESMO Clinical Practice Guideline on Metastatic Breast Cancer (2024)
- SRC-HER2CLIMB-MURTHY-2019: Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer (2019)
- SRC-KEYNOTE-355-CORTES-2020: Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355) (2020)
- SRC-KEYNOTE-522-SCHMID-2022: Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer (2022)
- SRC-MONARCHE-JOHNSTON-2023: Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial (2023)
- SRC-NATALEE-SLAMON-2024: Ribociclib plus Endocrine Therapy in Early Breast Cancer (2024)
- SRC-NCCN-BREAST-2025: NCCN Clinical Practice Guidelines — Breast Cancer (2025.v4)
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: 2026-05-12.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT07137416 | Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer | PHASE1 | RECRUITING | — | Phase 1 only Small N (<50) Single country | |
| NCT04115306 | Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer | PHASE1 / PHASE2 | RECRUITING | — | Biomarker: unclear Single country | |
| NCT05059444 | ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation | N/A | RECRUITING | — | — | |
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 THP — docetaxel + trastuzumab + pertuzumab (HER2+ metastatic 1L) (REG-THP-METASTATIC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Abemaciclib adjuvant (HR+/HER2- early high-risk breast cancer) (REG-ABEMACICLIB-ADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Ribociclib adjuvant + AI (HR+/HER2- early breast cancer; NATALEE) (REG-RIBOCICLIB-AI-ADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan TCHP — docetaxel + carboplatin + trastuzumab + pertuzumab (HER2+ neoadjuvant) (REG-TCHP-NEOADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic) (REG-TDXD-METASTATIC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Pembrolizumab + chemo (TNBC neoadjuvant) (REG-PEMBRO-CHEMO-TNBC-NEOADJUVANT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Pembrolizumab + chemotherapy (TNBC, metastatic PD-L1+) (REG-PEMBRO-CHEMO-TNBC-MET) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT07137416 Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04115306 Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer 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 |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-12.