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
NRG-BR002: Metastasis-directed ablation (SBRT/surgery) fails to extend PFS in oligometastatic breast cancer on 1L systemic therapy
NRG-BR002 tested metastasis-directed ablation (93% SBRT; remainder surgical resection)—a local control strategy intended to eradicate visible metastatic deposits—added to first-line systemic therapy in…
NCT02364557 - Trial result
Breast cancer
Samuraciclib + fulvestrant shows higher clinical benefit and numerically longer PFS after CDK4/6 inhibition in randomized Phase 2 breast cancer trial
Samuraciclib (CT7001) is an oral, selective CDK7 inhibitor designed to disrupt estrogen receptor-driven transcriptional programs that can sustain tumor growth after resistance to CDK4/6 inhibitors. In the three-arm,…
NCT05963984 - Trial result Spotlight
Breast cancer
Giredestrant (oral SERD) + everolimus improves PFS after CDK4/6 inhibition, with the strongest benefit in ESR1-mutated breast cancer
Giredestrant is an oral selective estrogen receptor degrader (SERD) designed to overcome ER-driven endocrine resistance, and everolimus is an oral mTOR inhibitor targeting the PI3K–AKT–mTOR pathway; the all-oral…
NCT05306340 - Trial result
Breast cancer
Ceralasertib (ATR inhibitor) + Olaparib (PARP inhibitor) hits 37.8% ORR in PARPi‑naïve BRCA‑mut HER2‑neg breast cancer
Ceralasertib is an oral ATR kinase inhibitor that amplifies replication stress and is hypothesized to resensitize tumors to PARP inhibition; here it was combined with olaparib (PARPi) in a modular Phase 1…
NCT02264678 - New trial
Breast cancer
Pilot study tests single-fraction stereotactic radiation plus endocrine therapy without lumpectomy in early breast cancer
This prospective, single-arm pilot from the Renaissance Institute of Precision Oncology and Radiosurgery tests whether a single fraction of highly conformal stereotactic radiation can serve as definitive local…
NCT07844759 Exploratory - New trial
Breast cancer
Phase 1 letrozole SIE study compares quarterly injectable and daily oral aromatase-inhibitor exposure
ROVI Pharmaceuticals Laboratories is running an open-label, one-sequence pharmacokinetic study comparing a long-acting quarterly injectable letrozole formulation with standard daily oral letrozole. Letrozole inhibits…
NCT07401381 Exploratory - Trial result
Breast cancer
Atezolizumab (PD-L1) + trastuzumab/pertuzumab chemo misses EFS/DFS lift in high-risk early HER2+ breast cancer
In the Phase III IMpassion050 trial (NCT03726879), atezolizumab (anti–PD-L1) was added to neoadjuvant pertuzumab + trastuzumab + chemotherapy and continued after surgery with HER2-directed therapy. Among 454 patients…
NCT03726879 - Trial result
Breast cancer
Pembrolizumab (PD-1) + Neoadjuvant Chemo Cuts Recurrence and Death in Asian Early TNBC Subgroup
Pembrolizumab is an anti–PD-1 checkpoint inhibitor given perioperatively with standard neoadjuvant chemotherapy (taxane + carboplatin → anthracycline/cyclophosphamide) and then continued as adjuvant monotherapy; this…
NCT03036488 - New trial
Breast cancer
Phase 2 TheraBionic P1 amplitude‑modulated RF electromagnetic field (tumor‑frequency EMF) device in HR+ breast cancer.
This Phase 2, open-label, single-arm study tests the TheraBionic P1 mouth device as a self-administered, non-drug intervention for locally advanced/unresectable or metastatic hormone receptor–positive (ER/PR >1% in…
NCT07227831 Exploratory - Trial result
Breast cancer
A tumor-informed ctDNA MRD assay flags post-surgery recurrence risk in early TNBC (HR 30.3)
This NSABP B-59/GBG-96-GeparDouze prospective ctDNA substudy used whole-exome sequencing of each patient’s primary tumor to build a bespoke “tumor-informed” circulating tumor DNA (ctDNA) MRD assay, testing serial…
- New trial
Breast cancer
Phase 2 ddCMF chemo (alkylator + antifolate + thymidylate synthase inhibitor) in older breast cancer
Memorial Sloan Kettering Cancer Center is running this Phase 2 feasibility study testing dose-dense CMF (cyclophosphamide, methotrexate, and 5‑fluorouracil) as an anthracycline-sparing alternative to AC…
NCT07768436 Exploratory - New trial
Breast cancer
Phase 2 DETENTE-1 tests pembrolizumab PD‑1 inhibitor with/without carbo‑taxane neoadjuvant therapy.
UT Southwestern’s Phase 2 randomized pilot study (DETENTE-1) evaluates whether tailoring neoadjuvant therapy can increase pathologic complete response (pCR) in treatment-naive stage I TNBC (T1a–T1c, M0) before…
NCT07786428 Exploratory - Trial result
Breast cancer
Olaparib (PARP inhibitor) Sustains OS/IDFS Gains at 6.1 Years in gBRCA High-Risk HER2− eBC (OlympiA)
Olaparib (Lynparza), an oral PARP inhibitor that exploits homologous recombination deficiency in germline BRCA1/2–mutated tumors, was tested vs placebo for 1 year in the randomized Phase 3 OlympiA trial (NCT02032823)…
NCT02032823 - New trial
Breast cancer
Phase 2 romosozumab sclerostin-directed monoclonal antibody as bone-anabolic therapy in bone-metastatic ER/PR+ breast cancer
Memorial Sloan Kettering Cancer Center is running REMOLD-Breast (Phase 2) to test whether romosozumab (Evenity; Amgen/UCB)—a sclerostin-neutralizing monoclonal antibody that increases bone formation and also reduces…
NCT07776613 Exploratory - Trial result
Breast cancer
THP (taxane + trastuzumab/pertuzumab) posts 43.8% pCR in stage II/IIIa HER2+ breast cancer—63.7% in ER− vs 32.4% in ER+
EA1181/CompassHER2 pCR (NCT04266249) tested neoadjuvant THP: 4 cycles of trastuzumab + pertuzumab with either weekly paclitaxel (12 weeks) or q3w docetaxel (x4), then surgery, in clinical stage II/IIIa HER2+ breast…
NCT04266249 - New trial Spotlight
Breast cancer
Phase 2 pembrolizumab PD‑1 inhibitor with anthracycline-sparing neoadjuvant chemo in high‑TIL TNBC
This Phase 2 NeoTILs study from the Medical University of South Carolina (MUSC) tests a biomarker-guided de-escalation strategy in stage II–IIIB triple-negative or hormone receptor–low (ER/PR <10%) invasive breast…
NCT07743190 Exploratory - New trial
Breast cancer
Phase 2 partial breast irradiation (EBRT) trial tests localized radiation field to omit axillary staging
NYU Langone Health is running RADIANS (NCT07723209), a single-arm, prospective pilot evaluating the safety and longer-term regional control of partial breast irradiation (PBI) delivered with external beam radiation…
NCT07723209 Exploratory - New trial
Breast cancer
Phase 1b/2 asciminib allosteric BCR-ABL inhibitor + trastuzumab HER2 mAb in HER2+ BrM
Duke University is running ASCENdANT, a single-arm, open-label Phase 1b/2 study testing asciminib plus trastuzumab for patients with metastatic HER2-positive breast cancer with brain metastases, with the primary goal…
NCT07136428 Exploratory - New trial
Breast cancer
Phase 3 SRG-514 ketorolac COX-1/2 inhibitor hydrogel placed in lumpectomy cavity in TNBC
SURGE Therapeutics is running a randomized, blinded Phase 3 study testing SRG-514, a ketorolac (NSAID) hydrogel placed intraoperatively into the breast-conserving surgery resection cavity, versus breast-conserving…
NCT07723469 Registrational - New trial
Breast cancer
Phase 1b/2 BreakVax personalized neoantigen vaccine + PD-1 and CTLA-4 blockade immunotherapy
BreakBio Corp’s Phase 1b/2 study tests a multi-component regimen built around BreakVax, a per-patient manufactured personalized vaccine intended to prime tumor-specific T cells (a neoantigen peptide immunotherapy) in…
NCT07762703 Exploratory - New trial
Breast cancer
Phase 2 neratinib pan-HER (EGFR/HER2/HER4) TKI added to endocrine therapy in ER+/HER2- breast cancer.
This single-center, randomized Phase 2 UC San Diego study tests whether adding neratinib (an oral, irreversible pan-HER tyrosine kinase inhibitor targeting EGFR/HER2/HER4) can improve disease control when layered…
NCT07729046 Exploratory - Trial result Spotlight
Breast cancer
Camizestrant (oral SERD) + CDK4/6i doubles PFS when ctDNA ESR1 mutations emerge on 1L AI
Camizestrant (AZD9833) is an oral selective estrogen receptor degrader (SERD) designed to antagonize and degrade ER, including mutant ER, and in SERENA-6 (Phase 3, double-blind) it was used as an early “molecular…
NCT04964934 - Trial result
Breast cancer
PH FDC SC (pertuzumab+trastuzumab) dual-HER2 blockade matches IV outcomes at 4 years in early breast cancer
PH FDC SC is a fixed-dose, subcutaneous co-formulation of pertuzumab (HER2 dimerization inhibitor) and trastuzumab (anti-HER2 mAb) designed to replace IV dosing while preserving exposure; in the Phase III FeDeriCa…
NCT03493854 - Trial result
Breast cancer
Pembrolizumab (PD-1) KEYNOTE-522 neoadjuvant regimen: gBRCA+ trends to higher pCR and 2-year RFS in early TNBC
Pembrolizumab, an anti–PD-1 antibody, combined with platinum/taxane → anthracycline/cyclophosphamide chemotherapy per the KEYNOTE-522 regimen (NCT03036488) was evaluated in a retrospective single-center real-world…
NCT03036488 - Trial result
Breast cancer
PLD (pegylated liposomal doxorubicin; immunogenic anthracycline) + pembrolizumab (PD-1) posts 67% disease control and 10 responses in heavily pretreated ER+/HER2− mBC
Pegylated liposomal doxorubicin (PLD), a liposomal anthracycline that can induce immunogenic cell death, was combined with pembrolizumab (PEM), an anti–PD-1 checkpoint inhibitor, in a Phase Ib, 2-cohort dose/schedule…
- Trial result Spotlight
Breast cancer
Inavolisib (PI3Kα inhibitor/p110α degrader) more than doubles PFS vs placebo in Asian PIK3CA-mut HR+/HER2– aBC
In the Phase 3 INAVO120 trial (NCT04191499), inavolisib (INAVO) is an oral, selective PI3Kα inhibitor that also promotes degradation of mutant p110α, combined with palbociclib (CDK4/6 inhibitor) plus fulvestrant…
NCT04191499 - Trial result Spotlight
Breast cancer
Durvalumab (PD-L1) + trastuzumab deruxtecan (HER2 ADC) delivers 62% ORR but 21% ILD in 1L HR−/HER2-low mBC
Durvalumab is an anti–PD-L1 checkpoint inhibitor and trastuzumab deruxtecan (T-DXd) is a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload; the combo was tested as first-line…
NCT03742102 - Trial result
Breast cancer
Tucatinib + T-DXd posts 51% ORR in pretreated HER2+ metastatic breast cancer
Tucatinib is an oral HER2-selective TKI combined here with trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate carrying a topoisomerase I payload, in the single-arm, open-label Phase 2 HER2CLIMB-04 trial…
NCT04539938 - Trial result
Breast cancer
Bria-IMT (SV-BR-1-GM whole-cell vaccine + GM-CSF) + PD-1 blockade shows 44% 12-mo OS in heavily pretreated MBC
Bria-IMT pairs SV-BR-1-GM (an irradiated allogeneic breast cancer cell-line vaccine engineered to secrete GM-CSF; given as IFNγ-stimulated vs unstimulated formulations) with PD-1 checkpoint inhibition (pembrolizumab…
NCT06072612 - Trial result
Breast cancer
Alpelisib (PI3Kα) benefit tracks with FGFR1/2 alterations and low TMB in SOLAR-1
Alpelisib is an oral PI3Kα-selective inhibitor combined with fulvestrant, an estrogen-receptor degrader, for HR+/HER2− advanced breast cancer with PIK3CA-altered disease. In this retrospective SOLAR-1 Phase 3…
NCT02437318
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