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Breast cancerJanuary 2026
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Breast Cancer — Monthly Compass
Jan 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in Breast Cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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Breast Cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • Giredestrant (oral SERD) improved invasive disease–free survival vs standard endocrine therapy in ER+/HER2− early breast cancer (HR=0.70) with fewer discontinuations and reassuring tolerability, signaling a potential first adjuvant endocrine backbone upgrade in two decades.
  • Important Drug Publication Updates
    • The Phase 3 PATINA trial showed adding palbociclib to maintenance anti‑HER2 and endocrine therapy significantly extended progression‑free survival to 44.3 months vs 29.1 months in HR+/HER2+ metastatic breast cancer, with higher rates of grade 3–4 neutropenia.
    • The Phase 3 ASCENT‑04 trial demonstrated that first‑line sacituzumab govitecan plus pembrolizumab significantly extended progression‑free survival compared with chemotherapy plus pembrolizumab in PD‑L1‑positive advanced triple‑negative breast cancer, with a manageable safety profile.
  • Key Clinical Development Updates
    • FDA accepted the NDA for gedatolisib in HR+/HER2−, PIK3CA wild‑type advanced breast cancer with Priority Review and a July 17, 2026 PDUFA goal date, processed under Real‑Time Oncology Review and supported by prior Breakthrough Therapy and Fast Track designations.
    • FDA approved use of Greenwich LifeSciences’ first commercial GP2 lot in the ongoing Phase 3 FLAMINGO‑01 trial, enabling vial shipments to 40 U.S. sites and additional manufacturing as a step toward a U.S. BLA filing under Fast Track.
  • Important Clinical Trial Publications
    • The PHENOMENAL phase 2 study reported an intracranial objective response rate of 22% with liposomal irinotecan in HER2‑negative breast cancer patients with progressive brain metastases, highlighting a potential systemic treatment option for this high‑need population.
    • The randomized phase 2b PIONEER trial found that megestrol plus letrozole significantly reduced Ki67 and ER transcriptional activity in early ER+ breast cancer, suggesting a novel therapeutic approach that may also improve adherence by managing hot flashes.
  • Key Conference Updates
    • January 2026 forums spanning SABCS 2025 coverage, the J.P. Morgan Healthcare Conference, an OncLive State of the Science Summit, and Best of Breast emphasized oral SERDs in adjuvant HR+ disease, bispecific immuno‑oncology in TNBC, targeted pathway‑IO combinations, and the migration of ADCs into earlier settings.
  • Emerging Themes & Macro-Trends
    • Partnering momentum during JPM‑week favored programs with validated targets, tolerability advantages, and earlier‑setting strategies, positioning these assets for near‑term value inflection.
    • Anticipated 2026 readouts flagged in January include ROSETTA BREAST‑01 for pumitamig, expansion outcomes from paxalisib phase 1b TNBC cohorts, and results from early‑stage ADC trials.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-01-01 and 2026-01-31 about Breast Cancer.
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Celcuity announced FDA acceptance of its NDA for gedatolisib to treat HR+/HER2–, PIK3CA wild-type advanced breast cancer; the filing received Priority Review with a PDUFA goal date of July 17, 2026. The NDA was processed under Real-Time Oncology Review and follows prior Breakthrough Therapy and Fast Track designations for the program.¹ (read more)
  • Immunomic Therapeutics reported FDA clearance of its IND for ITI-5000, a UNITE-based self-amplifying RNA vaccine for stage II–III triple-negative breast cancer. The clearance enables initiation of a first-in-human Phase 1 study in Q2 2026 evaluating ITI-5000 as monotherapy and in combination with pembrolizumab (Keytruda).² (read more)
  • Greenwich LifeSciences said FDA reviewed and approved use of its first commercial GP2 lot in the ongoing Phase 3 FLAMINGO-01 trial of GLSI-100. The company highlighted this as a step toward a U.S. BLA filing under Fast Track designation, with plans to ship approved vials to 40 U.S. sites and manufacture additional lots to support the submission.³ (read more)
Publications Related to Approved Drugs
There are no new publication updates during the 2026-01-01 to 2026-01-31 for Breast Cancer.
New Publications Related to Drugs in Clinical Trial Development
Phase 1
Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1. In this Phase I trial, the combination of the oral SERD camizestrant and the AKT inhibitor capivasertib demonstrated a well-tolerated safety profile and encouraging clinical efficacy in pretreated patients. The combination achieved a clinical benefit rate of 51.7% at 24 weeks and a median progression-free survival of 8.3 months, supporting further development in this setting.
Phase 3
The Effect of Itraconazole on the Pharmacokinetics of Vepdegestrant, a PROteolysis TArgeting Chimera Estrogen Receptor Degrader, in Healthy Adult Participants. This study evaluated the drug-drug interaction between the novel PROTAC ER degrader vepdegestrant and the strong CYP3A4 inhibitor itraconazole. Coadministration increased vepdegestrant exposure by 69%, confirming CYP3A4 involvement in its metabolism and informing dosing strategies for the ongoing Phase 3 VERITAC-2 trial.
Phase 3
Palbociclib for Hormone-Receptor-Positive, HER2-Positive Advanced Breast Cancer. The Phase 3 PATINA trial found that adding palbociclib to maintenance anti-HER2 and endocrine therapy significantly improved progression-free survival (44.3 vs. 29.1 months) compared to standard therapy in patients with HR+/HER2+ metastatic breast cancer. While efficacy was superior, the addition of the CDK4/6 inhibitor resulted in higher rates of grade 3-4 neutropenia.
Phase 3
OPERA-01: a phase III study of palazestrant for ER+, HER2- advanced breast cancer after CDK4/6 inhibitor therapy. This publication outlines the design of the Phase III OPERA-01 study, which evaluates palazestrant, a novel oral complete estrogen receptor antagonist (CERAN), versus standard endocrine therapy. The trial targets patients with ER+/HER2- advanced breast cancer who have progressed on prior CDK4/6 inhibitor therapy, regardless of ESR1 mutation status.
Phase 2
Biomarkers of response to neoadjuvant palbociclib plus anastrozole in endocrine-resistant estrogen receptor-positive/HER2-negative breast cancer: a phase 2 trial. In patients with endocrine-resistant ER+/HER2- breast cancer, resistance to neoadjuvant palbociclib plus anastrozole was linked to specific genomic subtypes and the upregulation of cell cycle and immune pathways. The study identified a 33-gene signature capable of predicting response, highlighting potential biomarkers for tailoring CDK4/6 inhibitor therapy.
Phase 3
Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. The Phase 3 ASCENT-04 trial demonstrated that first-line treatment with sacituzumab govitecan plus pembrolizumab significantly extended progression-free survival compared to chemotherapy plus pembrolizumab in patients with PD-L1-positive advanced triple-negative breast cancer. The combination showed a manageable safety profile consistent with the known effects of individual agents.
Phase 1
PI3Kα Inhibitor and Degrader Inavolisib Can Co-opt FGFR2 to Enhance Responses in Patients with PIK3CA-Mutated Solid Tumors and in Preclinical Models. Inavolisib, a p110α inhibitor and degrader, showed antitumor activity and a manageable safety profile in patients with PIK3CA-mutated solid tumors, including breast cancer. Translational data revealed that FGFR2 signaling cooperates with p110α degradation to enhance sensitivity, suggesting a potential synergistic strategy with FGFR2 inhibitors.
Phase 4
Prospective Single-Arm Study of Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node-Positive Early Breast Cancer Patients With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25). The INTERSTELLAR trial is investigating whether ovarian function suppression combined with endocrine therapy is non-inferior to chemotherapy for premenopausal women with pN1, low genomic risk ER+/HER2- breast cancer. This study aims to provide evidence for safely omitting chemotherapy in this specific patient population.
Phase 2
Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial. The bispecific HER2-directed antibody-drug conjugate TQB2102 demonstrated robust efficacy with total pathologic complete response rates ranging from 57.7% to 76.9% in neoadjuvant treatment of HER2-positive breast cancer. The therapy was well-tolerated, with no treatment-related deaths, marking it as a promising candidate for further development.
N/A
Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD. This protocol describes a randomized trial evaluating the CONCURxP mobile health intervention versus enhanced usual care to improve adherence to CDK4/6 inhibitors. The study utilizes smart pill pouches and real-time text reminders to address non-adherence in patients with HR+/HER2- breast cancer.
N/A
Adherence to oral endocrine therapy by menopausal status: post hoc insights from a remote monitoring randomized trial. A post hoc analysis revealed that app-based remote symptom monitoring significantly improved 12-month adherence to oral endocrine therapy in premenopausal women (53.9% vs. 25.0%). These findings suggest that digital health interventions may be particularly effective for younger patients who struggle with adherence.
Phase 3
Biomarkers for dietary fatty acid densities among postmenopausal United States females derived using a habitual-diet human feeding study. Researchers developed biomarker equations using serum and urine metabolites to objectively estimate dietary fatty acid densities in postmenopausal women. These biomarkers provide a more reliable method for studying the relationship between diet and chronic disease risk in large cohorts like the Women's Health Initiative.
Phase 3
Greater adherence to healthful dietary patterns is associated with lower insomnia risk in the Women's Health Initiative Observational Study. This study found that higher adherence to Mediterranean and DASH dietary patterns was associated with a significantly lower risk of incident and chronic insomnia in postmenopausal women. The results highlight diet quality as a modifiable lifestyle factor that may improve sleep health in this population.
Phase 1
Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence. Model-informed drug development facilitated the approval of a new soft gelatin capsule formulation of talazoparib by demonstrating that AUC equivalence was sufficient for safety, despite a higher Cmax. This approach allowed for successful bridging to the commercial formulation without compromising patient safety.
Phase 2
Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030). In the TBCRC-030 trial, both visual and computational assessments of tumor-infiltrating lymphocytes (TILs) were prognostic for response to neoadjuvant paclitaxel in triple-negative breast cancer. However, computational methods did not outperform standard visual assessment, suggesting further validation is needed before clinical implementation.
Phase 4
Efficacy of Topical Betamethasone Valerate and Olive Oil in Preventing Acute Radiation Dermatitis in Breast Cancer: A Randomized Double-Blind Placebo-Controlled Study. A randomized trial showed that olive oil cream was as effective as topical betamethasone valerate in preventing and alleviating acute radiation dermatitis in breast cancer patients. Both treatments significantly reduced dermatitis severity compared to placebo, offering a non-steroidal option for symptom management.
Phase 3
Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index. An adjusted Breast Cancer Index (BCI) model successfully identified a subgroup of premenopausal women with node-negative, HR-positive breast cancer who have a minimal (<5%) 10-year risk of distant recurrence. This classification could help personalize treatment by identifying patients who may safely de-escalate adjuvant therapy.
N/A
Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. This observational study confirmed that the trastuzumab biosimilar CT-P6, when combined with pertuzumab and chemotherapy, achieves pathologic complete response rates comparable to reference trastuzumab in HER2-positive early breast cancer. The regimen was well-tolerated with no new safety or immunogenicity signals.
Phase 3
Main factors associated with variability in the assessment of the objective response rate. A re-analysis of the PHEREXA phase 3 clinical trial. A re-analysis of the PHEREXA trial data confirmed that local investigators tend to overestimate objective response rates compared to blinded independent central review. The discrepancy was associated with the number of target lesions evaluated and specific organ sites, emphasizing the value of independent review in clinical trials.
Phase 3
Pembrolizumab for Early-Stage Triple-Negative Breast Cancer: KEYNOTE-522 Japan Subgroup Analysis. The Japanese subgroup analysis of the KEYNOTE-522 study confirmed the benefit of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab in high-risk early-stage TNBC. The regimen improved pathologic complete response rates and event-free survival with a safety profile consistent with the global population.
Phase 2
Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer. In the ALICE trial, adding atezolizumab to chemotherapy for metastatic TNBC improved patient-reported quality of life, emotional functioning, and pain control compared to chemotherapy alone. These findings support the clinical value of this combination beyond its impact on progression-free survival.
Phase 1
Phase Ib/II Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. Zanidatamab combined with tislelizumab and chemotherapy demonstrated a high confirmed objective response rate of 75.8% and durable responses in patients with HER2-positive gastric/GEJ adenocarcinoma. While this study focused on gastric cancer, the results validate the potential of this HER2-targeted bispecific antibody strategy.
Phase 2
Molecular profiling of chemotherapy-resistant breast cancer reveals DNA methylation remodeling associated with the acquisition of paclitaxel resistance. This study identified that DNA methylation remodeling is a key driver of paclitaxel resistance in breast cancer, with resistant tumors showing distinct epigenetic signatures. Treatment with the DNA methyltransferase inhibitor decitabine partially restored chemosensitivity, suggesting a potential strategy to overcome resistance.
Phase 2
Evaluating progesterone receptor agonist megestrol plus letrozole for women with early-stage estrogen-receptor-positive breast cancer: the window-of-opportunity, randomized, phase 2b, PIONEER trial. The PIONEER trial demonstrated that adding the progesterone receptor agonist megestrol to letrozole significantly reduced tumor proliferation (Ki67) in early-stage ER+ breast cancer. This combination also reduced ER transcriptional activity, suggesting a novel therapeutic approach that may also improve treatment adherence by managing hot flashes.
N/A
Acupuncture for peripheral neuropathy induced by paclitaxel in early-stage breast cancer: a randomized, parallel, controlled, blinded study in a Brazilian Oncologic Center (PACLILIN Study). A randomized controlled trial found that true acupuncture significantly reduced the severity of paclitaxel-induced peripheral neuropathy symptoms in breast cancer patients compared to sham acupuncture. The benefit was observed after 8 weeks of treatment, offering a non-pharmacologic option for this common adverse event.
Phase 2
Liposomal irinotecan in patients with HER2-negative breast cancer and brain metastases: The PHENOMENAL phase 2 study. The PHENOMENAL study showed that liposomal irinotecan has intracranial activity, achieving an intracranial objective response rate of 22% in patients with HER2-negative breast cancer and progressive brain metastases. These results highlight a potential systemic treatment option for a patient population with limited therapeutic choices.
Conference
Major Conference Updates
Conference Information
  • San Antonio Breast Cancer Symposium (SABCS) 2025, San Antonio, TX; December 9–12, 2025 (coverage published January 2026). (read more)
  • 44th J.P. Morgan Healthcare Conference, San Francisco, CA; January 12–15, 2026. (read more)
  • OncLive State of the Science Summit: Breast Cancer, New York, NY; January 13, 2026. (read more)
  • 2026 Best of Breast (Total Health), Fort Lauderdale, FL; January 17–18, 2026. (read more)
  • Overall sentiment: January forums emphasized mechanism-driven advances—oral SERDs in adjuvant HR+ disease, bispecific immuno‑oncology in TNBC, targeted pathway/IO combinations, and momentum for ADCs migrating into earlier settings.
  • Theme 1: Oral SERDs Redefine Adjuvant HR+ Disease
    • Significance: Emergence of giredestrant suggests the first endocrine backbone upgrade in two decades for ER+/HER2− early breast cancer. (read more)
    • Mechanism insights / clinical impact: Giredestrant (oral SERD) improved invasive disease–free survival vs standard endocrine therapy (HR=0.70) with fewer discontinuations and reassuring tolerability—supporting durable adherence advantages. (read more)
    • Patient populations affected: Stage I–III ER+/HER2− patients at medium/high risk; potential utility across menopausal status and clinical risk strata per lidERA Breast Cancer. (read more)
  • Theme 2: Bispecific Immuno‑Antiangiogenic Strategy in TNBC
    • Significance: PD‑L1×VEGF‑A bispecifics may expand benefit beyond PD‑L1–positive TNBC and consolidate dual biology into a single agent. (read more)
    • Mechanism insights / clinical impact: Pumitamig (BNT327/BMS986545) plus nab‑paclitaxel achieved cORR 61.5% (uORR 71.8%) in 1L/2L TNBC, aligning with SABCS‑presented data and informing phase 3 ROSETTA BREAST‑01. (read more)
    • Patient populations affected: Locally advanced/metastatic TNBC irrespective of PD‑L1 status; first‑ and second‑line settings. (read more)
  • Theme 3: PI3K/mTOR + IO/Chemo Combinations in Metastatic TNBC
    • Significance: Early signals support adding pathway inhibitors to immunochemotherapy to overcome resistance and deepen responses. (read more)
    • Mechanism insights / clinical impact: Paxalisib (pan‑PI3K/mTOR) combined with pembrolizumab and chemotherapy produced two partial responses among two evaluable trial patients and a confirmed complete metabolic response under expanded access; tolerability described as generally favorable. (read more)
    • Patient populations affected: PD‑L1–selected metastatic TNBC (trial cohort) and heavily pretreated TNBC under expanded access. (read more)
  • Theme 4: ADCs Push Into Early Triple‑Negative Disease
    • Significance: January education programs highlighted ongoing neoadjuvant/adjuvant ADC trials, signaling potential chemo‑sparing or response‑intensifying strategies earlier in the trajectory. (read more)
    • Mechanism insights / clinical impact: ADCs leverage tumor‑antigen targeting to deliver cytotoxics with improving efficacy/safety profiles; translational focus on TROP2 and other targets may optimize pathologic response and residual disease management. (read more)
    • Patient populations affected: Early‑stage TNBC candidates for neoadjuvant/adjuvant therapy across academic and community settings. (read more)
  • Significance
    • Expected clinical or translational readouts: Continued updates from ROSETTA BREAST‑01 (pumitamig), expansion of paxalisib phase 1b TNBC cohorts, and readouts from early‑stage ADC trials highlighted in January programs. (read more)
    • Regulatory or policy implications: Priority review news for gedatolisib in advanced breast cancer underscores an active 2026 regulatory slate alongside potential SERD submissions downstream of lidERA visibility. (read more)
    • Potential shifts in standard of care: If sustained, giredestrant could become a preferred adjuvant endocrine backbone; positive bispecific/ADC data could broaden chemo‑sparing or response‑intensifying approaches in TNBC. (read more)
    • Strategic implications: At JPM‑week and clinician forums, partnering gravitated to ADCs, bispecifics, and pathway‑IO combinations; companies positioned with validated targets, tolerability advantages, and early‑setting strategies are best placed for near‑term value inflection. (read more)
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in Breast Cancer updated from 2026-01-01 to 2026-01-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation--2-1-3
Not Yet Recruiting742115240
Recruiting5132461274161
Available-------
Approved for Marketing-------
Active, Not Recruiting17928224181
Completed9---1-10
Total8445974587295
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
WH002, paclitaxel injection NCT06513364 COMPLETED A Phase Ib Randomized Parallel Study of Comparing WH002 With Paclitaxel Both Sequential of Epirubicin and Cyclophosphamide As Neoadjuvant Treatment of Women With HER2-Negative Breast Cancer 2025-11-17
: MK-4700, : Pembrolizumab NCT06894771 COMPLETED A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors 2025-11-24
Olaparib, Fulvestrant, Palbociclib NCT03685331 COMPLETED Harnessing Olaparib, Palbociclib and Endocrine Therapy: A Phase I/II Trial of Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer (HOPE) 2025-12-01
Vorasidenib, Bupropion, Flurbiprofen, Omeprazole, Repaglinide, Rosuvastatin, Midazolam NCT07235748 COMPLETED A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants 2025-12-23
Niraparib, Talazoparib, ART4215 NCT04991480 COMPLETED A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors 2025-12-24
Itraconazole Capsule, HRS-8080 Tablet NCT07229560 COMPLETED The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study 2025-12-31
SNB-101 NCT04640480 COMPLETED A Phase I, Open-Label, Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Infused SNB-101(as SN-38) in Patients With Advanced Solid Tumors 2026-01-05
Nab-Paclitaxel, Pembrolizumab NCT02999477 COMPLETED A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer 2026-01-08
Standard of Care (SOC) gadolinium Breast MRI, reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. NCT04340180 COMPLETED Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction 2026-01-20
Letrozole LEBE 150 mg, Letrozole LEBE 75 mg, Letrozole LEBE 225 mg NCT06315205 ACTIVE_NOT_RECRUITING A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole LEBE at Different Strengths in Voluntary Healthy Post-Menopausal Women. 2026-02
[14C]HRS-8080 NCT07320521 NOT_YET_RECRUITING A Phase I Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects. 2026-03
Oxaliplatin, Fluorouracil, Leucovorin, Zimberelimab, AB598 NCT05891171 ACTIVE_NOT_RECRUITING A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies 2026-03
: Dendritic Cell Vaccine NCT05809752 RECRUITING A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) 2026-03
Capivasertib, Rosuvastatin NCT07088913 RECRUITING An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin (a BCRP, OATP1B1 and OATP1B3 Sensitive Substrate) in Healthy Participants 2026-03-26
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
dose-dense nab-paclitaxel followed by EC NCT05728268 RECRUITING Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index 2025-12-30
Aromatase inhibitor, Alpelisib, Fulvestrant NCT04762979 ACTIVE_NOT_RECRUITING A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer 2026-05
Azacitidine NCT04891068 RECRUITING BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer 2026-05
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Pertuzumab IV, Trastuzumab Emtansine, Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), Trastuzumab IV, Investigator's Choice of Chemotherapy NCT05415215 COMPLETED A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer 2025-11-07
Induction of anesthesia with dexmedetomidine nasal spray prior to surgery NCT07350928 RECRUITING A Phase III Randomized Controlled Clinical Trial Evaluating the Efficacy of Preoperative Dexmedetomidine Hydrochloride Nasal Spray in Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status 2026-03-01
Exemestane Tablets, Tamoxifen, Anastrozole Tablets, TOL2506, Letrozole Tablets NCT04906395 ACTIVE_NOT_RECRUITING Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer 2026-04-30
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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