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 Spotlight
Breast cancer
Rezatapopt Restores Mutant p53, Yields 38% ORR in Heavily Pretreated TP53 Y220C-Mutated Metastatic Breast Cancer
Rezatapopt (PC14586) is an oral, first-in-class small-molecule that binds the p53 Y220C pocket, refolding the mutant protein into a wild-type conformation and reactivating tumor-suppressor function. In the Phase 1…
NCT04585750 - Trial result Spotlight
Breast cancer
Chemo-Free Durvalumab + Trastuzumab + Pertuzumab Yields 49% pCR (68% RCB0/1) in HER2-Enriched Early Breast Cancer
The single-arm Phase II DTP trial (NCT03820141) treated 39 stage I–III, ER/PR-negative, (by a BluePrint [BP] 80-gene molecular subtyping test that classifies early-stage breast cancer (EBC) into Basal, Luminal, and…
NCT03820141 - Trial result
Breast cancer
Real-World Endocrine-Resistant HR+/HER2- mBC Progresses in ≈8 mo on First-Line CDK4/6i, with 40% PIK3CA Mutations
A Flatiron Health EHR review (2015-2023) captured 7,096 U.S. patients starting first-line therapy for recurrent HR+/HER2- metastatic breast cancer. Among 922 who met INAVO120 endocrine-resistant criteria and still…
- Trial result
Breast cancer
Five-Fraction Ablative RT + Endocrine Therapy Achieves 53% pCR, Skips Surgery in Stage I HR+ Breast Cancer
A single-arm Phase II trial (NCT02945579) enrolled 20 women ≥ 50 y with unicentric, stage I HR+/HER2- tumors (Oncotype ≤25). After three months of endocrine therapy and hypofractionated ablative radiotherapy (37.5…
NCT02945579 - Trial result
Breast cancer
Olaparib + Durvalumab (PARP/PD-L1) Achieve 70% pCR, Early CD8+ Spike in TNBC
In the window-of-opportunity MEDIOLA Phase II trial (NCT03594396), 54 stage II/III triple-negative or ER-low breast-cancer patients received 4 weeks of olaparib (PARP inhibitor) with a single durvalumab dose before…
NCT03594396 - Trial result
Breast cancer
Ipatasertib Triplet Doubles PFS in PI3K/AKT/PTEN-Mutant HR+/HER2- Metastatic Breast Cancer After CDK4/6
Ipatasertib—the oral pan-AKT inhibitor—was tested in the Phase Ib TAKTIC trial (NCT03959891) alongside fulvestrant ± palbociclib in 77 pre-treated, CDK4/6-exposed HR+/HER2- MBC patients. In the 20-patient triplet…
NCT03959891 - Trial result
Breast cancer
Palazestrant + Ribociclib Shows 79% Clinical Benefit After Prior CDK4/6 Exposure in ER+/HER2- Metastatic Breast Cancer
Palazestrant (OP-1250), an oral complete ER antagonist/SERD that degrades both wild-type and mutant ESR1, was dose-escalated to 120 mg once daily alongside standard ribociclib 600 mg (3 weeks on/1 week off) in a…
- Trial result
Breast cancer
Zelenectide Pevedotin (Nectin-4 BTC) Delivers 50% ORR in NECTIN4-Amplified, Heavily Pretreated TNBC
Zelenectide pevedotin is a low-molecular-weight Bicycle® toxin conjugate that ferries MMAE to Nectin-4; in the Phase 1b DURAVELO-1 dose-expansion (5 mg/m² weekly), 32 triple-negative breast-cancer patients with a…
- Trial result
Breast cancer
KAT6 Inhibitor PF-07248144 + Fulvestrant Posts 37% ORR and 10.7-Month PFS After CDK4/6 Failure in ER+/HER2⁻ mBC
PF-07248144, an oral catalytic inhibitor of the histone acetyltransferases KAT6A/B, was given at 5 mg QD to 43 heavily pre-treated ER+/HER2⁻ metastatic breast-cancer patients alongside standard fulvestrant (Phase 1…
NCT04606446 - Trial result
Breast cancer
Zanidatamab + Evorpacept Delivers 56% ORR in Centrally-Confirmed HER2-Positive mBC After T-DXd
Zanidatamab is a bispecific antibody that dimerizes HER2 receptors and triggers ADCC/ADCP, while evorpacept is a “silent-Fc” CD47 blocker that augments macrophage phagocytosis. In the open-label phase 1b/2 trial…
NCT05027139 - Trial result
Breast cancer
Tucatinib + Alpelisib (HER2 TKI + PI3Kα) Nets 60% Partial Responses in Heavily Pretreated HER2-Positive, PIK3CA-Mutated mBC
In the phase Ib P5-03-10 “Time-to-Event” dose-escalation study (NCT05230810) post-menopausal women with HER2-positive metastatic breast cancer harboring activating PIK3CA mutations (median 2 prior metastatic lines;…
NCT05230810 - Trial result
Breast cancer
Taxane + SC Pertuzumab/Trastuzumab Scores 86% pCR in Node-Negative HER2+/HR⁻ Early Breast Cancer (DECRESCENDO)
Neoadjuvant weekly taxane plus fixed-dose subcutaneous pertuzumab-trastuzumab for 12 weeks yielded pCR (ypT0/Tis N0) in 113/131 patients (86%) with 15–50 mm, node-negative, hormone-receptor-negative HER2-positive…
- Trial result
Breast cancer
Bria-IMT Whole-Cell Vaccine plus PD-1 Blockade Extends Median OS to 13.4 mo in Heavily Pretreated HR+/HER2- mBC
Bria-IMT combines irradiated HER2/GM-CSF–secreting allogeneic breast-cancer cells with low-dose cyclophosphamide, peg-IFN-α, and pembrolizumab/retifanlimab; 54 metastatic-breast-cancer patients (median 6 prior lines)…
NCT03328026 - Trial result
Breast cancer
Elacestrant (oral SERD) + Everolimus mTOR Blockade Yields 81% 24-wk CBR in Pre-treated ER+/HER2- mBC
Elacestrant 258–345 mg QD combined with everolimus 5–10 mg (ELEVATE phase 1b; NCT05563220) enrolled 23 heavily pre-treated ER+/HER2- metastatic breast-cancer patients (all post-CDK4/6i); safety was dominated by…
NCT05563220 - Trial result
Breast cancer
Larotrectinib Delivers 53% ORR—and 83% in Secretory Subtype—with 73% 4-Year Durability in TRK-Fusion Breast Cancer
Larotrectinib, a highly selective CNS-penetrant TRK inhibitor, was evaluated across NAVIGATE and SCOUT (n = 16; TRK-fusion breast cancer). Notably, NTRK fusions are rare in breast cancer (0.4%) but are present in 90%…
- New trial
Breast cancer
Phase 1b Study of Axatilimab (CSF1R mAb) in Metastatic TNBC
This open-label, single-arm trial evaluates the combination of pembrolizumab, radiotherapy, and axatilimab for patients with metastatic or recurrent TNBC who have received prior immunotherapy. Conducted in Los…
NCT07015853 Exploratory - New trial
Breast cancer
Phase 1 trial of [68Ga]Ga DOTA-5G, somatostatin receptor-targeted PET/CT diagnostic agent.
This prospective trial at University of California, Davis evaluates [68Ga]Ga DOTA-5G PET/CT imaging after a 5 mCi injection in patients with advanced invasive lobular breast cancer. The study examines the safety and…
NCT07020806 First-in-human - Trial result Spotlight
Breast cancer
T-DXd HER2 ADC nearly doubles PFS over chemo in HER2-low HR+ mBC
Trastuzumab deruxtecan (T-DXd), an anti-HER2/topo-I antibody-drug conjugate, was pitted against capecitabine or taxane chemotherapy in the phase 3 DESTINY-Breast06 trial (NCT04494425). In the 625-patients with ctDNA…
NCT04494425 - Trial result
Breast cancer
Zongertinib Irreversible HER2 TKI Posts 27% ORR with Zero ≥G3 Toxicity in Refractory HER2-Driven MBC
Zongertinib is a covalent HER2 tyrosine-kinase inhibitor. In the Phase Ia dose-escalation study (NCT04886804) 15 heavily pre-treated stage IV breast cancer patients with HER2 amplification/over-expression or mutation…
NCT04886804 - Trial result Spotlight
Breast cancer
Camizestrant Switch Halves Progression Risk in Emerging ESR1-Mutant HR+/HER2- mBC
Camizestrant, a next-generation oral selective estrogen-receptor degrader, was tested in the phase 3 SERENA-6 trial (NCT04964934). 315 ER-positive/HER2-negative metastatic breast cancer patients who developed an ESR1…
NCT04964934 - Trial result
Breast cancer
Inavolisib + Palbo–Fulvestrant Adds 7 mo OS Benefit in PIK3CA-Mut HR+/HER2- mBC
Inavolisib, a PI3Kα-selective inhibitor, was combined with palbociclib and fulvestrant in the double-blind, randomized Phase 3 INAVO120 trial (NCT04191499). The trial population included 325 CDK4/6-naïve patients…
NCT04191499 - Trial result
Breast cancer
Fixed-Dose SC Pertuzumab/Trastuzumab Delivers 94% 3-Year IDFS in Early HER2+ Breast Cancer
In the randomized phase II PHranceSCa crossover trial (NCT03674112), 159 adjuvant HER2-positive early-stage patients received three cycles of a fixed-dose subcutaneous pertuzumab-trastuzumab combo (PH FDC SC) and…
NCT03674112 - Trial result
Breast cancer
Atezolizumab + Paclitaxel + Bevacizumab Triplet Hits 11-mo PFS in PD-L1-Negative First-Line TNBC
Atezolizumab (anti-PD-L1 mAb) combined with paclitaxel and bevacizumab (anti-VEGF) was tested in the single-arm phase 2 ATRACTIB study (NCT04408118) as first-line therapy for advanced triple-negative breast cancer…
NCT04408118 - Trial result
Breast cancer
Elacestrant + Everolimus (mTOR) Delivers 8.5 mo PFS After CDK4/6 Failure in ER+/HER2- mBC
Elacestrant, an oral selective estrogen-receptor degrader (SERD), was paired with either everolimus (mTOR inhibitor) or ribociclib (CDK4/6 inhibitor) in the phase 1b/2 ELEVATE umbrella study (NCT05563220). In…
NCT05563220 - Trial result
Breast cancer
ESG401 TROP2-Directed ADC Hits 83% ORR First-Line TNBC, ~35% in Heavily Pretreated Breast Cancers
ESG401, an ADC consisting of humanized anti-TROP2 IgG1 conjugated to SN-38. ESG401 was evaluated in the phase 1 ESG401-101 study in China (NCT04892342) across 156 patients with metastatic breast and other solid…
NCT04892342 - Trial result
Breast cancer
Inavolisib Adds 7 Months OS atop Palbo-Fulvestrant in PIK3CA-Mutant HR⁺/HER2- MBC
In the Phase 3 double-blind INAVO120 trial (NCT04191499), 161 women with endocrine-resistant, PIK3CA-mutated HR+⁺/HER2- metastatic breast cancer received the PI3Kα inhibitor inavolisib plus palbociclib-fulvestrant;…
NCT04191499 - Trial result
Breast cancer
12-Week Dual-HER2 ± Paclitaxel Delivers 97% 5-Yr OS in De-Escalated HER2-Positive Early Breast Cancer
A pooled analysis of 713 patients from three trials (NCT01817452, NCT01779206, NCT03272477) tested short-course neoadjuvant regimens—trastuzumab + pertuzumab with or without 12 weekly paclitaxel, or antibody–drug…
NCT01817452 - Trial result
Breast cancer
Alpelisib + Sacituzumab Govitecan Yields 36% ORR (50% in TNBC) at Recommended Phase-2 Dose
In a 3 + 3 phase I dose-escalation study (NCT05143229), 12 women with heavily pre-treated, HER2-negative metastatic breast cancer received daily alpelisib (an α-specific PI3K inhibitor) plus sacituzumab govitecan (A…
NCT05143229 - Trial result
Breast cancer
ctDNA Surveillance Pinpoints Relapse Risk in High-Risk ER+/HER2- Breast Cancer—Early Clearance Triples on Palbo + Fulvestrant
In the multicenter DARE trial (NCT04567420), 552 high-risk ER+/HER2- patients on adjuvant endocrine therapy underwent Signatera™ ctDNA testing every 6 mo. Over a median 27 mo, 432 remained ctDNA-negative and showed a…
NCT04567420 - New trial
Breast cancer
Phase 3 EG1206A HER2 mAb vs. Perjeta: Neoadjuvant Breast Cancer Trial
This study compares the efficacy and safety of EG1206A versus Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant and adjuvant treatments for HER2-positive, hormone receptor–negative early breast…
NCT06884254
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