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

Last updated: April 26, 2026

Current Clinical Trial Landscape

Active research areas in 2026:

Antibody-drug conjugates — ADCs (152 trials): T-DXd, sacituzumab govitecan, sacituzumab tirumotecan, datopotamab deruxtecan, next-gen bispecific ADCs
CDK4/6 inhibitors (160 trials): next-generation agents, new combinations, adjuvant expansion, post-CDK4/6i strategies
Checkpoint immunotherapy (146 trials): pembrolizumab in TNBC, PD-1/VEGF bispecifics, de-escalation studies
PIK3CA/AKT pathway inhibitors (43 trials): inavolisib, capivasertib, gedatolisib, RLY-2608 (mutant-selective)
PARP inhibitors (54 trials): olaparib, talazoparib, saruparib (next-gen PARP1-selective) for BRCA-mutated tumors
Oral SERDs (next-gen endocrine): camizestrant, palazestrant, D-0502 — replacing fulvestrant injections

Standard of care by subtype: HR+/HER2-: Endocrine therapy + CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib) for metastatic; adjuvant endocrine therapy ± abemaciclib for high-risk early-stage. HER2+: Trastuzumab + pertuzumab + chemotherapy; T-DXd after prior trastuzumab. TNBC: Pembrolizumab + chemotherapy (neoadjuvant/adjuvant for early-stage); sacituzumab govitecan or T-DXd for metastatic. BRCA-mutated: Olaparib or talazoparib for HER2- metastatic; olaparib adjuvant for high-risk HER2- early-stage.

Key Biomarkers for Trial Eligibility

Breast cancer treatment is driven by biomarkers. Knowing your status determines which trials you're eligible for:

Hormone receptor (ER/PR) status — ER+ and/or PR+ (~70% of breast cancers). Determines eligibility for endocrine therapy trials, CDK4/6 inhibitor combinations, and oral SERD trials.
HER2 status — HER2-positive (~15-20%), HER2-low (IHC 1+ or IHC 2+/ISH-negative, ~50%), or HER2-zero (IHC 0). HER2-low is now a distinct treatment category with T-DXd approved. HER2 ADC trials require specific IHC/FISH testing.
BRCA1/2 germline mutation — present in ~5-10% overall (higher in TNBC). Eligible for PARP inhibitors (olaparib, talazoparib, saruparib), platinum-based chemotherapy, and combination trials.
PIK3CA mutation — present in ~40% of HR+/HER2- tumors. Eligible for PI3K inhibitors (inavolisib, alpelisib), AKT inhibitors (capivasertib), and PI3K/mTOR inhibitors (gedatolisib).
PD-L1 expression (CPS) — determines eligibility for pembrolizumab in TNBC. CPS ≥10 is the standard cutoff for metastatic TNBC immunotherapy.
Ki-67 proliferation index — high Ki-67 may qualify for more intensive treatment or specific trial arms. Used in some risk stratification systems (e.g., Oncotype DX).
Tumor mutational burden (TMB) — TMB-high (≥10 mut/Mb) eligible for pembrolizumab regardless of subtype.

Know your HER2, ER/PR, and BRCA status? Get matched to breast cancer trials in minutes.

Find Matching Trials

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)

Showing selected notable trials. View all 1,835 recruiting interventional trials on ClinicalTrials.gov.

Frequently Asked Questions

How do I find breast cancer clinical trials for my subtype?

Enter your breast cancer details into ClinTrialFinder — including HER2 status (positive, low, or zero), hormone receptor status (ER/PR), BRCA mutations, PIK3CA status, PD-L1 expression, and prior treatments. The AI matches you with trials based on your specific profile in minutes. No login required.

What breast cancer trials are currently recruiting?

There are 1,835 recruiting interventional trials for breast cancer including ADCs (trastuzumab deruxtecan, sacituzumab govitecan, sacituzumab tirumotecan), CDK4/6 inhibitors, checkpoint immunotherapy, PARP inhibitors for BRCA-mutated tumors, PI3K/AKT pathway inhibitors for PIK3CA-mutated disease, oral SERDs, and PD-1/VEGF bispecific antibodies.

What is HER2-low breast cancer and how does it affect trial options?

HER2-low is a newer classification for breast cancers with IHC 1+ or IHC 2+/ISH-negative HER2 expression — about 50% of all breast cancers. Trastuzumab deruxtecan (T-DXd) is now FDA-approved for HER2-low metastatic breast cancer based on the DESTINY-Breast04 trial. Additional HER2-low-specific ADC trials (SKB264, SHR-A1811) are recruiting. Ask your pathologist to confirm your exact HER2 IHC score.

What options are there after CDK4/6 inhibitor progression in HR+ breast cancer?

After progressing on CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib), options include: PI3K/AKT pathway inhibitors (capivasertib, inavolisib for PIK3CA-mutated), ADCs (T-DXd, sacituzumab govitecan), oral SERDs (camizestrant, palazestrant), and next-generation PARP inhibitors (saruparib for BRCA-mutated). Many Phase 3 trials are specifically recruiting post-CDK4/6i patients.

Find Breast Cancer Trials Matched to Your Situation

Enter your subtype, biomarkers (HER2, ER/PR, BRCA, PIK3CA), and treatment history to get AI-matched results in minutes.