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
Pembro Lead-In Lifts ORR to 47% and Extends OS to 26 mo in Metastatic TNBC
In a single-institution Phase II trial (NCT02752685) enrolling 50 patients with metastatic triple-negative breast cancer (TNBC), regardless of PD-L1 status, investigators compared two sequential “run-in” strategies…
NCT02752685 - Trial result
Breast cancer
Oncolytic HSV TVEC + Taxane/AC Regimen Yields 46% pCR and 87% 5-Year DFS in Stage II-III TNBC
Talimogene laherparepvec (TVEC) is an intratumoral herpes oncolytic virus engineered to secrete GM-CSF and enhance antitumor immunity. In a single-arm Phase 1/2 study (NCT02779855) involving 46 patients with stage…
NCT02779855 - Trial result
Breast cancer
Ultrasound TVR > 50% at Week 6 Pinpoints 94% of pCRs on Keynote-522 in Early TNBC
In the prospective ARTEMIS study (NCT02276443), 150 patients with stage I–III triple-negative breast cancer received the KN-522 regimen, which includes paclitaxel (a taxane), carboplatin (a platinum-based…
NCT02276443 - Trial result
Breast cancer
H&E-Based Gene-Expression Signature Stratifies pCR 8% vs 59% in ISPY2 Neoadjuvant Breast-Cancer Study
A transformer model capable of inferring 38 gene-expression signatures directly from biopsy H&E slides was applied to 579 HER2-negative patients in the I-SPY2 trial (chemotherapy ± immunotherapy). An…
- Trial result
Breast cancer
Anti-CD73 Oleclumab Fails but ctDNA Wins in First-Line mTNBC
In the randomized Phase I/II SYNERGY trial (NCT03616886), 133 untreated patients with locally advanced or metastatic triple-negative breast cancer (TNBC) received weekly carboplatin (a platinum-based chemotherapy)…
NCT03616886 - Trial result
Breast cancer
High-Grade Neutropenia Marks Palbociclib Benefit in Early HR-Positive Breast Cancer
In PALLAS (N = 5,736 stage II–III HR+/HER2- cases), adding the CDK4/6 inhibitor palbociclib to adjuvant endocrine therapy (ET) failed overall, but an exploratory look at the 2,840 palbo-treated patients showed that…
- New trial
Breast cancer
Phase 1/2 Trial of Sacituzumab Govitecan in TROP2-Positive Triple-Negative Breast Cancer
Gilead Sciences is evaluating sacituzumab govitecan-hziy—a TROP2-directed antibody-drug conjugate delivering SN38—in advanced TNBC using alternate dosing schedules to assess safety, tolerability, ORR, and PFS.
NCT06926920 - New trial
Breast cancer
Phase II ctDNA-Guided Elacestrant Trial in ER+ HER2- Breast Cancer
Yale University is conducting a single-arm phase II study to evaluate elacestrant—a small molecule estrogen receptor inhibitor—at an FDA-approved dose of 345 mg daily for adjuvant treatment in ER+ HER2- breast cancer…
NCT06923527 - Trial result
Breast cancer
PF-07248144, a first‐in‐class KAT6 inhibitor, achieves optimal 5 mg dose with fulvestrant in ER+/HER2– metastatic breast cancer
In phase 1 expansion, 5 mg PF-07248144 plus fulvestrant demonstrated an ORR of 37.2% (vs 24.1%) with a median duration of response of 15.8 months (vs 4.8 months at 1mg) and median PFS of 10.7 months (vs 3.6 months at…
- New trial
Breast cancer
Phase 1/2 Trial of BNT323 + BNT327 in Advanced HER2-Low/Ultralow/Null Breast Cancer
BioNTech is running a multi-site, open-label study evaluating the combination of BNT323—using DB-1303, a HER2-directed mAb ADC—and BNT327, a VEGFA-directed mAb, in patients with advanced breast cancer across a…
NCT06827236 - New trial
Breast cancer
Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer
The NCI trial is evaluating ASTX727—combining decitabine (a hypomethylation agent) with cedazuridine (a cytidine deaminase inhibitor)—in combination with paclitaxel and pembrolizumab across 1st to 4th line metastatic…
NCT05673200 - New trial
Breast cancer
Feasibility Pilot of Topical Azelaic Acid in Breast Cancer Radiation
Virginia Commonwealth University is assessing the feasibility of twice-daily application of azelaic acid—an investigational anti-inflammatory natural product—in breast cancer patients undergoing concurrent…
NCT06966388 - Trial result
Breast cancer
Nivolumab Plus Low-Dose Ipilimumab Shows Promise in Hypermutated HER2-Negative Metastatic Breast Cancer
In the phase II NIMBUS trial, HER2-negative metastatic breast cancer (MBC) patients with high tumor mutational burden (TMB ≥9 mut/Mb) received nivolumab and low-dose ipilimumab, achieving an overall objective…
- New trial
Breast cancer
H-ASSIST: Ultra Hypo-fractionated WBI with SIB for Early-Stage Breast Cancer
UNC Lineberger Comprehensive Cancer Center is evaluating a 5-fraction whole breast irradiation regimen with a simultaneous integrated tumor bed boost in early-stage breast cancer and ductal carcinoma in situ to…
NCT06902311 - New trial
Breast cancer
Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer
Yale is conducting an open-label Phase Ib study evaluating two combination regimens—sacituzumab govitecan with nivolumab versus the same agent paired with fixed-dose nivolumab and relatlimab—in PD-L1 positive…
NCT06963905 - New trial
Breast cancer
Phase 1 Study: BGB-21447 Combination Therapy in HR+/HER2- Metastatic Breast Cancer
BeiGene is evaluating the safety and tolerability of BGB-21447—a Bcl-2 inhibitor—in combination with fulvestrant, with or without BGB-43395 (a CDK4 inhibitor), in adults with HR+/HER2- metastatic breast cancer.…
NCT06756932 - New trial
Breast cancer
LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer
This phase III trial is comparing low-dose tamoxifen to standard endocrine therapy (aromatase inhibitors or full-dose tamoxifen) for post-menopausal, hormone-positive, HER2-negative early stage breast cancer, with…
NCT06671912 - New trial
Breast cancer
Phase Ib/II Study: Low Dose Cyclophosphamide with Axatilimab and Retifanlimab in Metastatic TNBC
M.D. Anderson Cancer Center is evaluating the optimal dosing of low dose oral cyclophosphamide in combination with axatilimab (a CSF1R-directed mAb) and standard-dose retifanlimab (a PD-1 mAb) to treat patients with…
NCT06959537 - New trial
Breast cancer
FAST NOVEMBER: A Phase II Randomized Trial of a 5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
University of Utah is evaluating the optimal duration for whole breast radiotherapy—with both 5- and 9-day schedules using a brachytherapy device—in early-stage adjuvant breast cancer.
NCT06961955 - New trial
Breast cancer
Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)
This randomized trial compares a one-week radiotherapy regimen (2600 cGy in 5 fractions) with a two-week schedule (3200 cGy in 10 fractions plus a concomitant tumor bed boost to 3600 cGy) to evaluate side effects,…
NCT06960707 - New trial
Breast cancer
Phase I Trial: Adjuvant Alpha-lactalbumin Vaccine in High-Risk TNBC
Case Comprehensive Cancer Center is evaluating the safety and optimal dosing of an α‑lactalbumin vaccine combined with zymosan in a Phase I trial targeting non-metastatic triple-negative breast cancer patients at…
NCT04674306 - Trial result
Breast cancer
Trastuzumab Deruxtecan Enhances Quality of Life in HER2-Low Metastatic Breast Cancer
In the DESTINY-Breast04 trial, patients with HER2-low metastatic breast cancer treated with trastuzumab deruxtecan maintained stable global health status and quality of life over a longer treatment duration, with…
- Trial result
Breast cancer
Breast Tumor-Bed Biopsy Falls Short of Sufficient pCR Prediction in Neoadjuvant Breast Cancer
In the phase 2 NRG-BR005 trial of 101 evaluable patients with operable invasive ductal carcinoma who achieved a clinical and radiological complete or near-complete response post-neoadjuvant chemotherapy, adding…
- Trial result
Breast cancer
Chemotherapy-Free Triplet Regimen Shows Promise in Pre-Treated HR+/HER2+ Metastatic Breast Cancer
In this phase 2a study of 51 heavily pretreated patients with hormone receptor-positive, HER2-positive metastatic breast cancer, the chemotherapy-free combination of zanidatamab, palbociclib, and fulvestrant achieved…
- New trial
Breast cancer
Phase I Trial: HER2-Directed Peptide Vaccine in Locally Advanced Breast Cancer
This study tests an investigational HER2-directed peptide vaccine designed to activate the immune system against high-risk, HER2-positive breast cancer through a series of intramuscular injections given every 21 days…
NCT06949410 - New trial
Breast cancer
Phase 2 Trial: Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
City of Hope Medical Center is evaluating a five-fraction regimen that delivers both whole breast and lumpectomy cavity radiation over consecutive business days, aiming to reduce treatment time while maintaining…
NCT06954831 - New trial
Breast cancer
Phase II Adjuvant Trial: Evaluating Chemotherapy Omission in ER+/HER2– Breast Cancer
Yale University is investigating whether ribociclib combined with optimized endocrine therapy, minus adjuvant chemotherapy, improves treatment adherence and outcomes in moderate to high-anatomical risk, low-genomic…
NCT06953882 - Trial result
Breast cancer
FALCON Final OS Analysis: Fulvestrant and Anastrozole Deliver Comparable Survival Outcomes in Advanced HR+ Breast Cancer
In the phase III FALCON trial, postmenopausal, endocrine therapy-naïve women with HR+/HER2– advanced breast cancer showed similar overall survival (median OS 44.8 vs 42.7 months; HR 0.97, P = .7579) between…
- New trial
Breast cancer
Phase 2 Umbrella Study Evaluates Boserolimab with Standard Neoadjuvant Therapy in High-Risk Early-Stage TNBC
This trial by Merck Sharp & Dohme LLC investigates whether adding boserolimab to a standard regimen of pembrolizumab, paclitaxel, and carboplatin before surgery enhances safety, tolerability, and pCR rates in newly…
NCT06829199 - New trial
Breast cancer
Phase 3 Trial Evaluates Sacituzumab Tirumotecan Alone and with Pembrolizumab in PD-L1-Low Metastatic TNBC
Merck Sharp & Dohme LLC is testing whether IV sacituzumab tirumotecan, given alone or with pembrolizumab, can improve overall survival and delay progression compared to physician’s choice chemotherapy in first-line,…
NCT06841354
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