Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in breast cancer
- Trial result
Breast cancer
Abbreviated THP (paclitaxel+trastuzumab+pertuzumab) drives 99% 5-year EFS in stage II–III HER2+ breast cancer
In the single-arm Phase 2 DAPHNe trial secondary analysis (NCT03716180), patients with stage II–III ERBB2(HER2)-positive breast cancer received 12 weeks of neoadjuvant paclitaxel plus dual HER2 blockade with…
NCT03716180 - Trial result
Breast cancer
HER2-ultralow rescoring finds ~45% prevalence inside “HER2-0” advanced breast cancer
HER2-ultralow refers to IHC 0 tumors with faint/incomplete membrane staining, a boundary that may matter as trastuzumab deruxtecan extends HER2-directed ADC activity below classic HER2-low disease. In a Mayo Clinic…
- Trial result
Breast cancer
Concurrent boost (SIB) during whole-breast RT matches sequential boost control in high-risk early breast cancer, shortening treatment time
NRG/RTOG 1005 tested whether delivering the lumpectomy-cavity boost concurrently (a simultaneous integrated boost using 3D-CRT/IMRT) could maintain local control versus the standard sequential boost delivered after…
- Trial result
Breast cancer
MammaPrint H2 (70-gene signature) flags anthracycline benefit in HR+/HER2− early breast cancer
MammaPrint is a 70-gene prognostic signature; in FLEX real-world, prospectively collected data, the investigators asked whether its High-Risk 1 (H1) vs High-Risk 2 (H2) subgroups predict incremental benefit from…
- Trial result
Breast cancer
SUBITO: Olaparib (PARP inhibitor) matches IACT (alkylator + auto-SCT) for 4-year OS in stage III HRD breast cancer
SUBITO (Phase 3, open-label; NCT02810743) randomized newly diagnosed stage IIIA–C, HER2-negative, HRD breast cancer (n=174; median age 42; 25%–32% gBRCA1/2+) to intensified alkylating chemotherapy with autologous…
NCT02810743 - Trial result
Breast cancer
NRG/NSABP B-35 (tamoxifen vs anastrozole) suggests “close” DCIS margins don’t meaningfully worsen IBTR with WBI
In the Phase 3, double-blind NSABP B-35 trial (NCT00053898), 3104 postmenopausal women with HR-positive DCIS underwent lumpectomy + whole-breast irradiation (WBI) and were randomized to 5 years of tamoxifen (SERM) vs…
NCT00053898 - New trial
Breast cancer
Phase 2 STEMVAC DNA vaccine targets CDH3/CD105/YB-1/MDM2/SOX2 in residual TNBC.
University of Washington is running a randomized Phase 2 adjuvant study testing STEMVAC, a multiantigen plasmid DNA cancer vaccine designed to induce T-cell responses against five “aggressiveness/stemness”-associated…
NCT07721259 Exploratory - New trial Spotlight
Breast cancer
Phase 1 ITI-5000 saRNA vaccine targets HERV-K/CT83 tumor antigens (LAMP-1 enhanced)
This first-in-human, Phase 1, multicenter, open-label study (VITAL-TNBC) tests ITI-5000, a lipid-nanoparticle (LNP)–delivered self-amplifying RNA (saRNA) therapeutic vaccine from Immunomic Therapeutics in people with…
NCT07652242 First-in-human - New trial
Breast cancer
Phase 3b camizestrant oral SERD + ribociclib CDK4/6 inhibitor in 1L ER+/HER2− ABC.
AstraZeneca’s SERAFA-1 is a single-arm, open-label, multicenter Phase 3b study testing camizestrant (an oral selective estrogen receptor degrader that binds ER and promotes ER degradation, including in ESR1-mutant…
NCT07647328 Exploratory - New trial
Breast cancer
Phase 2 APBI multicatheter HDR brachytherapy (local radiation) single-fraction after lumpectomy
Virginia Commonwealth University (VCU) is running this Phase 2, single-arm prospective study to test the safety of accelerated partial breast irradiation delivered as multicatheter interstitial brachytherapy in a…
NCT07654257 Exploratory - New trial Spotlight
Breast cancer
Phase 3 BGB-43395 CDK4-selective inhibitor plus letrozole vs CDK4/6 inhibitors in 1L HR+/HER2- MBC
This open-label, randomized, multicenter Phase 3 study (BeOne Medicines) tests whether BGB-43395—an oral, CDK4-selective small-molecule inhibitor—combined with letrozole (aromatase inhibitor) improves outcomes versus…
NCT07492641 Registrational - Trial result Spotlight
Breast cancer
T-DXd (HER2 ADC) + durvalumab (PD-L1) delivers ~83% ORR and ~38-month mPFS in 1L HER2+ mBC
Trastuzumab deruxtecan (T-DXd) is a HER2-targeted antibody–drug conjugate (topoisomerase I payload), combined here with durvalumab, an anti–PD-L1 antibody, as first-line therapy in the DESTINY-Breast07 Phase 1b/2…
NCT04538742 - Trial result Spotlight
Breast cancer
T-DXd (HER2 ADC) + pertuzumab: CRs deepen slowly (8.4mo) but track with NC PFS in 1L HER2+ mBC
Trastuzumab deruxtecan (T-DXd) is a HER2-directed antibody–drug conjugate (topoisomerase I payload) combined with pertuzumab (HER2 dimerization-blocking mAb) in the Phase 3 DESTINY-Breast09 first-line setting…
NCT04784715 - Trial result Spotlight
Breast cancer
Giredestrant (oral SERD/full ER antagonist) cuts recurrence risk in ER+/HER2– early breast cancer—benefit holds in pre- and postmenopause
Giredestrant (GIRE) is a next-generation oral selective estrogen receptor degrader (SERD) and full ER antagonist tested as 5-year adjuvant endocrine therapy in the global, randomized Phase III lidERA BC trial…
NCT04961996 - Trial result Spotlight
Breast cancer
Tucatinib (HER2 TKI) + trastuzumab/pertuzumab extends PFS as 1L HER2+ MBC maintenance—benefit holds across HR/BM subgroups
Tucatinib (TUC), an oral HER2-selective tyrosine kinase inhibitor, was evaluated in the Phase 3 HER2CLIMB-05 maintenance trial (NCT05132582) after induction taxane + trastuzumab/pertuzumab (HP) in HER2+ metastatic…
NCT05132582 - Trial result Spotlight
Breast cancer
Intratumoral DC1 (type 1 dendritic cell) immunotherapy + dual HER2 blockade drives 89% pCR in HR−/HER2+ early breast cancer
IT DC1 is an intratumoral conventional type 1 dendritic-cell (cDC1/DC1) therapy intended to inflame the tumor microenvironment; in the single-arm Phase 2 NATASHA trial (NCT05325632), patients with stage I–III HER2+…
NCT05325632 - Trial result Spotlight
Breast cancer
Dato-DXd (TROP2 ADC) extends PFS2/TFST/TSST vs chemo in 1L IO-ineligible metastatic TNBC
Datopotamab deruxtecan (Dato-DXd) is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload (deruxtecan); in the Phase 3, open-label TROPION-Breast02 trial (NCT05374512), previously…
NCT05374512 - Trial result Spotlight
Breast cancer
Sacituzumab govitecan (TROP2 ADC) + pembrolizumab extends PFS vs chemo+pembro across TROP2, tBRCA, and HER2-low mTNBC subgroups
Sacituzumab govitecan (SG) is a TROP2-directed antibody–drug conjugate delivering SN-38, combined here with pembrolizumab (PD-1 inhibitor) as first-line therapy in the Phase 3 ASCENT-04/KEYNOTE-D19 trial…
NCT05382286 - Trial result Spotlight
Breast cancer
ZN-A-1041 (BBB-permeable HER2 TKI) + T-DXd drives 65%–76% ORR in HER2+ mBC (incl CNS mets)
ZN-A-1041 is an oral, selective HER2 tyrosine kinase inhibitor designed for high intact blood–brain barrier permeability; in the Phase Ic ZN-A-1041-101-US trial (NCT05593094), it was combined with trastuzumab…
NCT05593094 - Trial result Spotlight
Breast cancer
Gedatolisib (pan-PI3K/mTORC1/2 inhibitor) + fulvestrant ± palbociclib doubles PFS vs alpelisib in PIK3CA-mut HR+/HER2− ABC
Gedatolisib (IV, comprehensive PI3Kα/β/δ/γ + mTORC1/2 inhibitor) was tested in the randomized, open-label Phase 3 VIKTORIA-1 Study 2 (NCT05501886) in HR+/HER2− PIK3CA-mutant advanced breast cancer after progression…
NCT05501886 - Trial result
Breast cancer
Cavity shave margins (CSM) cut positive margins/re-excisions but do not improve DFS or OS at ~5 years in Stage 0–III breast cancer (SHAVE + SHAVE2 pooled).
In the pooled SHAVE (single-center) and SHAVE2 (9-site US) randomized trials (n=631; Stage 0–III planned partial mastectomy; median follow-up 60.4 months), patients were intraoperatively randomized after standard…
NCT01452399 - Trial result
Breast cancer
Pembrolizumab (PD-1) added to neoadjuvant THP trends toward higher 3-year EFS in stage II–III HER2+ breast cancer
In the randomized Phase 2 neoHIP trial (NCT03747120), patients with stage II–III HER2-positive breast cancer received neoadjuvant paclitaxel + trastuzumab + pertuzumab (THP) with or without pembrolizumab (an…
NCT03747120 - Trial result
Breast cancer
Durvalumab (PD-L1) + paclitaxel posts ~56% ORR in 1L mTNBC; capivasertib (AKT) or oleclumab (CD73) add little
Durvalumab is an anti–PD-L1 monoclonal antibody combined here with weekly paclitaxel chemotherapy, with exploratory triplets adding capivasertib (a pan-AKT inhibitor) or oleclumab (an anti-CD73 adenosine-pathway…
NCT03742102 - Trial result
Breast cancer
HER2-targeted trastuzumab shows “on-time” benefit but late RFS drop-off in HER2+ lobular breast cancer
Trastuzumab (anti-HER2 monoclonal antibody) outcomes were dissected by histology in the Phase III adjuvant NCCTG N9831 trial (NCT00005970), comparing HER2+ invasive lobular carcinoma (ILC; n=122) vs invasive ductal…
NCT00005970 - Trial result
Breast cancer
Low-dose RT (9Gy) + pembrolizumab boosts early T-cell infiltration and trends to higher nodal clearance in node+ TNBC
TBCRC-053 (P-RAD; NCT04443348) tested adding preoperative breast-only radiation (0Gy vs 9Gy vs 24Gy) concurrently with pembrolizumab to a KEYNOTE-522–like neoadjuvant backbone (paclitaxel/carboplatin → AC, all with…
NCT04443348 - Trial result
Breast cancer
RT→pembrolizumab (PD-1) preop window yields higher major pathologic response than pembrolizumab→RT in early breast cancer
Pembrolizumab is an anti–PD-1 immune checkpoint inhibitor, and this Phase 1b/2 multi-arm adaptive “window-of-opportunity” study (NCT04454528) tested whether a single 7Gy RT fraction sequenced before vs after a single…
NCT04454528 - Trial result
Breast cancer
Sacituzumab govitecan (TROP2 ADC delivering SN-38) extends PFS vs taxane or gem/carbo across Trop-2, tBRCA, and HER2-low subgroups in 1L advanced TNBC
Sacituzumab govitecan (SG) is a TROP2-targeted antibody–drug conjugate delivering the topo-I inhibitor payload SN-38; in the Phase 3 ASCENT-03 trial (NCT05382299), previously untreated locally advanced…
NCT05382299 - Trial result
Breast cancer
Vepdegestrant (PROTAC ER degrader) + abemaciclib delivers 30.6% ORR (45.0% in ESR1m) post-CDK4/6 in ER+/HER2− ABC
Vepdegestrant is an oral proteolysis targeting chimera (PROTAC) estrogen receptor (ER) degrader combined with abemaciclib, an oral CDK4/6 inhibitor, in Substudy A of the open-label Phase 1b/2 TACTIVE-U umbrella study…
NCT05548127 - Trial result
Breast cancer
Elacestrant (oral SERD) + capivasertib (AKT inhibitor) posts 11.3-mo mPFS in post-CDK4/6 ER+/HER2− ABC (Ph 1b)
Elacestrant is an oral selective estrogen receptor degrader (SERD) combined here with capivasertib, an oral AKT inhibitor, to address endocrine resistance driven by ESR1 mutations and PI3K/AKT/PTEN pathway…
NCT05563220 - Trial result
Breast cancer
Tersolisib (LY4064809/STX-478) mutant-selective PI3Kα inhibitor shows 19–35% ORR with low hyperglycemia in PIK3CA-mutant HR+/HER2- ABC
Tersolisib is an oral, allosteric, CNS-penetrant, pan-mutant-selective PI3Kα inhibitor designed to spare wild-type PI3Kα and potentially reduce PI3K-inhibitor class toxicities; in the PIKALO-1 Phase 1/2 trial…
NCT05768139
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