Breast Cancer Clinical Trials (2026): 1,835 Recruiting Interventional Studies

Last updated: April 2, 2026

Current Clinical Trial Landscape

Trials by Subtype

HR+/HER2- (Hormone Receptor Positive)

The most common subtype (~70%). Standard treatment includes endocrine therapy + CDK4/6 inhibitors. Key areas of innovation:

• After CDK4/6i progression:
  • NCT04862663 - CAPItello-292: Capivasertib + CDK4/6i + Fulvestrant (Phase 3)
  • NCT05861830 - DAWNA-FES: Dalpiciclib + Endocrine Therapy after CDK4/6i failure (Phase 3)
  • NCT06081959 - SKB264 (sacituzumab analog ADC) for HR+/HER2- (Phase 3)
  • NCT06312176 - Sacituzumab Tirumotecan (MK-2870) + Pembrolizumab vs TPC (Phase 3)
• PIK3CA-mutated:
  • NCT06790693 - Inavolisib + CDK4/6i + Letrozole vs Placebo (Phase 3, first-line)
  • NCT06982521 - RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant (Phase 3)
  • NCT06757634 - Gedatolisib (PI3K/mTOR) as first-line treatment (Phase 3)
• Next-gen SERDs / oral endocrine:
  • NCT06016738 - Palazestrant (OP-1250) vs SOC for ER+/HER2- (Phase 3)
  • NCT05774951 - Camizestrant in ER+/HER2- early breast cancer (Phase 3)
  • NCT06954961 - D-0502 for ER+/HER2- advanced breast cancer (Phase 3)
• Adjuvant CDK4/6i expansion:
  • NCT06341621 - Chemo omission with extended adjuvant abemaciclib, 1-3 positive nodes (Phase 3)
  • NCT07190443 - AURA: Adjuvant abemaciclib for locoregional recurrence (Phase 3)
  • NCT05827081 - Ribociclib + ET in early breast cancer (Phase 3b)
• BRCA-mutated HR+:
  • NCT06380751 - Saruparib (AZD5305) + Camizestrant vs CDK4/6i + ET (Phase 3)

HER2-Positive

325 recruiting trials. Standard treatment includes trastuzumab + pertuzumab ± chemotherapy. Focus on de-escalation and new ADCs:

• Neoadjuvant (before surgery):
  • NCT06891833 - BL-M07D1 (ADC) ± Pertuzumab vs Taxane+THP (Phase 2/3)
  • NCT04547907 - Nab-PHP vs TCbHP in HER2+ early breast cancer (Phase 3)
  • NCT05883852 - EC-THP vs TCbHP in HER2+ node-positive (Phase 3)
  • NCT07393425 - SHR-A1811 (T-DXd analog) + Pertuzumab neoadjuvant (Phase 2)
• Metastatic / Advanced:
  • NCT06846437 - JSKN003 vs T-DM1 for HER2+ advanced (Phase 3)
  • NCT07008976 - TQB2102 vs T-DM1 for HER2+ advanced (Phase 3)
  • NCT07294508 - HLX22 + HLX87 for HER2+ recurrent/metastatic (Phase 2/3)
  • NCT05894239 - Inavolisib + Phesgo for PIK3CA-mutated HER2+ (Phase 3)
• De-escalation:
  • NCT06876714 - ShortStop-HER2: 12 vs 6 months HER2-targeted therapy after pCR (Phase 3)
  • NCT06992882 - Oral chemo + trastuzumab vs paclitaxel + trastuzumab, node-negative (Phase 3)

Triple-Negative Breast Cancer (TNBC)

306 recruiting trials. Immunotherapy + chemotherapy is now standard in early TNBC. Active frontiers include ADCs and de-escalation:

• First-line metastatic:
  • NCT06926868 - Izalontamab Brengitecan (ADC) vs Chemo, first-line mTNBC (Phase 2/3)
  • NCT06419621 - PM8002 (PD-L1/VEGF bispecific) + Nab-Paclitaxel, first-line (Phase 3)
  • NCT06767527 - AK112 (PD-1/VEGF bispecific) + Nab-Paclitaxel, first-line (Phase 3)
  • NCT07173751 - ROSETTA: Pumitamig in TNBC (Phase 3)
• Pretreated / later-line:
  • NCT06841354 - Sacituzumab Tirumotecan (MK-2870) ± Pembrolizumab in TNBC (Phase 3)
  • NCT06279364 - SKB264 vs Chemo in recurrent/metastatic TNBC (Phase 3)
  • NCT07111832 - SHR-A1811 in TNBC (Phase 3)
• Neoadjuvant / early-stage:
  • NCT06081244 - ADAPT-TN-III: SG vs SG+Pembrolizumab in low-risk early TNBC (Phase 3)
  • NCT06606730 - Personalizing pembrolizumab use based on response (Phase 3)
  • NCT05999149 - Camrelizumab + Chemo ± Famitinib neoadjuvant (Phase 3)
  • NCT03150576 - Platinum + PARP inhibitor neoadjuvant for TNBC/gBRCA (Phase 2/3)
• Post-neoadjuvant (non-pCR):
  • NCT06393374 - Sacituzumab Tirumotecan + Pembrolizumab vs TPC in non-pCR TNBC (Phase 3)
  • NCT06533384 - PARPi or Capecitabine + PD-1 inhibitor adjuvant in high-risk TNBC (Phase 3)

HER2-Low

54 recruiting trials. A newer subtype classification (IHC 1+ or IHC 2+/ISH-). T-DXd is already approved in this setting:

• NCT06836792 - T-DXd vs Endocrine Therapy in HER2-low HR+ advanced (Phase 2)
• NCT06486883 - T-DXd vs CDK4/6i-based ET as first-line in HR+/HER2-low (Phase 2)
• NCT07071337 - SKB264 vs Chemo in HR+/HER2-low advanced (Phase 3)

Novel Approaches

• Next-gen ADCs: Sacituzumab tirumotecan (MK-2870), SKB264, izalontamab brengitecan, SHR-A1811 — improving on first-gen ADCs with new payloads and targets
• Bispecific antibodies: PD-1/VEGF bispecifics (PM8002, AK112, ivonescimab), HER2 bispecifics (zanidatamab, HLX22+HLX87) — 30 recruiting trials
• Next-gen PARP inhibitors: Saruparib (AZD5305) with improved selectivity for PARP1, combined with novel endocrine agents
• Oral SERDs: Camizestrant, palazestrant (OP-1250), D-0502 — replacing fulvestrant injections
• Radiopharmaceuticals: NCT05870579 - [177Lu]Lu-NeoB + Ribociclib + Fulvestrant for GRPR+ ER+/HER2- (Phase 1b)

Trial listings from ClinicalTrials.gov. Page summaries generated by AI and may contain errors. Always verify with your healthcare provider.

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