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
- New trial
Breast cancer
Phase 2 Signatera™ ctDNA MRD surveillance to time CDK4/6 inhibition (CDK4/6 cell-cycle blockade)
This prospective, single-arm, multicenter Phase 2 study from Natera tests whether ctDNA (molecular residual disease) using the tumor-informed Signatera Genome assay can guide *when* to start adjuvant CDK4/6 inhibitor…
NCT07214532 Exploratory - New trial
Breast cancer
Phase 2 inavolisib PI3Kα inhibitor + ribociclib CDK4/6 inhibitor + fulvestrant ER degrader in HR+ ABC
This Phase 2 multicenter, randomized, double-blind, placebo-controlled Roche/Genentech study tests whether adding inavolisib (a PI3Kα inhibitor) to ribociclib (a CDK4/6 inhibitor marketed by Novartis as Kisqali) plus…
NCT07405801 Exploratory - New trial
Breast cancer
Pilot feasibility study uses IONM for nerve identification during ALND (ICBN/MBCN monitoring)
University of Cincinnati is running an interventional, pilot feasibility study in breast cancer patients undergoing axillary lymph node dissection (ALND) to see whether intraoperative neuromonitoring (IONM)—a…
NCT07528638 Exploratory - New trial
Breast cancer
Phase 1 HLD-0117 oral RIPTAC with no disclosed target/MOA in ER+ metastatic breast cancer
*No disclosed MOA. We do not include details of trials without this basic information.*
NCT07524855 First-in-human - New trial
Breast cancer
Phase I Trial of Avasopasem, a Superoxide Dismutase Mimetic, in Metastatic HR+ Breast Cancer
This trial evaluates the safety of adding Avasopasem—a superoxide dismutase mimetic—to CDK4/6 and hormonal (aromatase inhibitor) therapy in women with metastatic HR+ HER2– breast cancer that has progressed on…
NCT07137871 Exploratory - New trial Spotlight
Breast cancer
Phase 3 patritumab deruxtecan study of HER3-directed ADC in HR+/HER2- breast cancer
This open-label, randomized Phase 3 trial, sponsored by Merck Sharp & Dohme LLC, evaluates whether patritumab deruxtecan—a HER3-directed antibody–drug conjugate delivering a topoisomerase I inhibitor—improves…
NCT07060807 Registrational - New trial
Breast cancer
Pilot SBIR trial: MBI-guided biopsy using radiotracer uptake to target tumor metabolism.
This pilot trial by Smart Breast Corp. compares supplemental molecular breast imaging (MBI) to standard digital breast tomosynthesis (DBT) for cancer detection in women with dense breasts (BIRADS C or D).…
NCT07114679 Exploratory - New trial
Breast cancer
Phase 1 Pilot Study of Breast Radiation: Ionizing DNA Damage Agent
This multi-institutional pilot study led by Alexander Stessin explores whether adding whole-breast external beam radiation therapy to standard care can reduce cancer progression in patients with unresectable, locally…
NCT07122713 Exploratory - New trial Spotlight
Breast cancer
Phase II STEMVAC DNA Vaccine Targeting Breast Cancer Stem Cell Proteins
This phase II trial investigates STEMVAC in combination with standard endocrine therapy plus a CDK4/6 inhibitor or capecitabine in patients with hormone receptor–positive, HER2-negative metastatic breast cancer.…
NCT07112053 Exploratory - New trial
Breast cancer
Phase 3 trial: RLY-2608, a PI3K alpha inhibitor, with fulvestrant for advanced HR+/HER2– breast cancer
This global, multicenter open-label randomized study compares RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant in patients with locally advanced or metastatic HR+/HER2– breast cancer harboring PIK3CA…
NCT06982521 Registrational - New trial
Breast cancer
Phase II STEMVAC DNA vaccine targeting breast cancer stem cell antigens.
This Phase II trial at University of Washington evaluates the immunogenicity of STEMVAC, a DNA vaccine engineered to stimulate Th1 responses against MDM2, YB1, SOX2, CDH3, and CD105 expressed by breast cancer stem…
NCT07078604 Exploratory - New trial
Breast cancer
Phase II Hypofractionated EBRT, fine-tuning targeted ionizing radiation for nodal control in breast cancer.
This Phase II trial at M.D. Anderson evaluates shortened adjuvant regional nodal irradiation schedules using hypofractionated external beam radiation therapy (EBRT) via different dose regimens, including simultaneous…
NCT07076485 Exploratory - New trial
Breast cancer
Phase 1b/2 Disitamab Vedotin ADC (tubulin inhibitor) in advanced breast cancer
This open-label trial by Pfizer evaluates disitamab vedotin monotherapy in adults with metastatic or locally advanced breast cancer expressing various HER2 levels and hormone receptors. Participants receive an IV…
NCT06966453 Exploratory - New trial
Breast cancer
Phase II Dato-DXd ADC Targeting TROP2 and Topoisomerase I in TNBC.
This prospective, interventional single-arm trial by UNC Lineberger Comprehensive Cancer Center evaluates ctDNA-based MRD in stage II/III triple negative breast cancer patients with residual disease post-neoadjuvant…
NCT07069595 Exploratory - Trial result Spotlight
Breast cancer
Biomarker Duo sTILs + TNBC-DX Flags 91% pCR With PD-1/Carbo-Taxane in Early TNBC
Pembrolizumab, a PD-1 antibody, combined with neoadjuvant docetaxel-carboplatin (TCb + Pem) in the Phase II NeoPACT study (NCT03639948, n = 115) for stage I-III triple-negative breast cancer delivered a 58% overall…
NCT03639948 - New trial Spotlight
Breast cancer
Phase 3 Sac-TMT ADC: TROP2-directed antibody-drug conjugate.
This Phase 3 trial compares sac-TMT (a TROP2-directed antibody-drug conjugate) plus pembrolizumab and chemotherapy to a pembrolizumab-chemotherapy regimen as neoadjuvant treatment. Enrolling patients with high-risk,…
NCT06966700 Registrational - New trial
Breast cancer
Phase II: Trastuzumab (HER2-directed mAb) trial combining surgery, radiation, and SBRT for HER2+ breast cancer
This randomized study assesses whether adding surgery, locoregional radiation therapy, and SBRT to standard systemic treatment (trastuzumab, a HER2-directed antibody; pertuzumab, another HER2 inhibitor; and…
NCT07053085 Exploratory - New trial
Breast cancer
Phase IIIb Study: Ribociclib CDK4/CDK6 Inhibitor in HR+ HER2- Early Breast Cancer Adjuvant Setting
The trial evaluates safety and efficacy of ribociclib, a CDK4/CDK6 inhibitor, combined with standard adjuvant endocrine therapy in HR+ HER2- early-stage breast cancer patients, including a subgroup with Stage IIA…
NCT05827081 Registrational - Trial result
Breast cancer
BRCA/PALB2 Mutations Cut Real-World PFS to 11 mo on First-Line CDK4/6i in HR+/HER2− mBC
Using France’s ESME registry, investigators retrospectively analyzed 4820 women with HR+/HER2− metastatic breast cancer who initiated first-line CDK4/6 inhibition plus endocrine therapy between 2013-2023 (palbociclib…
- Trial result
Breast cancer
Bria-IMT Vaccine + Pembrolizumab Shrinks Brain Mets in 5 of 6 Patients; Tumor-Agnostic Basket Trial Launches
Bria-IMT—an irradiated, GM-CSF–secreting allogeneic breast-cancer cell line (SV-BR-1-GM) that functions as an antigen-presenting vaccine—is moving into the single-site ASTRO-VAC CNS phase 1 basket (NCT06072612) after…
NCT06072612 - New trial Spotlight
Breast cancer
Phase 3 Inavolisib PI3K inhibitor trial in advanced breast cancer
This multicenter study by Hoffmann-La Roche compares inavolisib plus letrozole and a CDK4/6 inhibitor versus placebo with the same backbone in patients with PIK3CA-mutated, hormone receptor–positive, HER2–negative…
NCT06790693 Registrational - New trial
Breast cancer
Phase II Ivonescimab, a PD-1/VEGF bispecific antibody trial
This single arm study evaluates ivonescimab added to carboplatin and docetaxel administered every 3 weeks for 6 cycles as neoadjuvant therapy in early-stage triple negative breast cancer. Sponsored by Cedars-Sinai…
NCT07017673 Exploratory - New trial
Breast cancer
Phase 2 Mayo Ultrasound Marker: Enhancing lymph node imaging via twinkling artifact
This trial evaluates the safety and ultrasound performance of an optimized marker in women with biopsy-confirmed, node-positive breast cancer. Using ultrasound-guided placement followed by imaging and surgical…
NCT06999798 Exploratory - New trial
Breast cancer
Phase I/II Trial: Naxitamab (GD2 mAb) + Sacituzumab Govitecan (TROP2-directed ADC)
This study evaluates safety, dosing, and efficacy of the combination in metastatic triple-negative breast cancer patients eligible for second-line or later treatment. Conducted by MD Anderson in Houston, the trial…
NCT07011654 Exploratory - New trial
Breast cancer
Phase II trial of darolutamide, an androgen receptor inhibitor, in early-stage AR+ TNBC
This study compares neoadjuvant standard chemotherapy plus immunotherapy with versus without darolutamide in stage II-IIIA AR+ triple-negative breast cancer at Nashville, sponsored by Vandana Abramson. It evaluates…
NCT07016399 Exploratory - New trial
Breast cancer
Phase 2/3 trial of Izalontamab Brengitecan, EGFR/HER3 bispecific ADC with topoisomerase inhibition
This randomized, open-label study compares iza-bren monotherapy versus physician’s choice in first-line metastatic triple-negative or ER-low, HER2-negative breast cancer patients ineligible for anti-PD(L)1 or…
NCT06926868 Registrational - Trial result Spotlight
Breast cancer
T-DXd Outscores T-DM1 Across HER2 Copy-Number, PI3K, and HRD Genomic Subsets in DESTINY-Breast03
In this ctDNA biomarker dive from the Phase III DESTINY-Breast03 trial (n≈420), researchers profiled >700 genes at baseline and progression. Despite wide heterogeneity—PIK3CA 48%, TP53 73%, HER2 amplifications…
- Trial result Spotlight
Breast cancer
Gedatolisib (pan-PI3K/mTOR) Triplet Hits 85% ORR in HR+/HER2- mBC
Gedatolisib 180 mg IV weekly plus palbociclib and letrozole/fulvestrant was explored in the phase 1b NCT02684032 dose-expansion (four cohorts by prior therapy). ORR reached 85% with 72% 12-mo PFS in treatment-naïve…
NCT02684032 - Trial result Spotlight
Breast cancer
RLY-2608 Mutant-Selective PI3Kα Inhibitor Achieves 31% ORR and 9-Month mPFS with Minimal Grade 3 Hyperglycemia in Post-CDK4/6 HR+/HER2⁻ mBC
RLY-2608 is an oral, allosteric PI3Kα inhibitor that binds only oncogenic PIK3CA variants, sparing wild-type signaling to reduce metabolic toxicity. In the phase 1 ReDiscover trial, 52 heavily pre-treated HR+/HER2⁻…
- Trial result Spotlight
Breast cancer
T-DXd + Pyrotinib Hits 100% PR in Phase Ib First-Line HER2-Positive mBC (TROPHY)
Trastuzumab deruxtecan (T-DXd), a HER2-directed topoisomerase-I ADC, was paired with the irreversible pan-HER TKI pyrotinib in the TROPHY phase Ib dose-finding study (NCT06245824). Five previously untreated…
NCT06245824
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