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ClinicalTrials.gov public records Last synced May 21, 2026, 5:34 PM EDT

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Showing 1–24 of 93 matching trials from the live ClinicalTrials.gov search.

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Filters: Condition: HER2 Gene Mutation Clear all

Completed Phase 1 Interventional

Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours

NCT02260661

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Conditions: Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -, Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
Interventions: AZD8835, AZD8835 in combination with fulvestrant; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years to 130 Years

Enrollment: 20 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2016
U.S. locations: 5
States / cities: Denver, Colorado • Greenville, South Carolina • Nashville, Tennessee + 2 more

Source: ClinicalTrials.gov public record

Updated Oct 9, 2016 · Synced May 21, 2026, 5:34 PM EDT

Terminated No phase listed Observational

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

NCT03786107

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Conditions: Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
Interventions: Almac HER-Seq Assay; Diagnostic Test
Lead sponsor: Puma Biotechnology, Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 1,583 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2021
U.S. locations: 1
States / cities: Pittsburgh, Pennsylvania

Source: ClinicalTrials.gov public record

Updated May 18, 2021 · Synced May 21, 2026, 5:34 PM EDT

Recruiting No phase listed Observational

DESTINY-PANTUMOUR04

NCT07124000

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Conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
Interventions: Trastuzumab deruxtecan; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years to 130 Years

Enrollment: 100 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2028
U.S. locations: 17
States / cities: Birmingham, Alabama • Bullhead City, Arizona • Casa Grande, Arizona + 14 more

Source: ClinicalTrials.gov public record

Updated Apr 30, 2026 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 3 Interventional

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

NCT06452277

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Conditions: Advanced Non-small Cell Lung Cancer, HER2 Mutation
Interventions: Sevabertinib, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed; Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older

Enrollment: 444 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2029
U.S. locations: 27
States / cities: Newport Beach, California • San Diego, California • San Francisco, California + 21 more

Source: ClinicalTrials.gov public record

Updated May 17, 2026 · Synced May 21, 2026, 5:34 PM EDT

Terminated Phase 3 Interventional Results available

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

NCT01905592

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Conditions: Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Neoplasms
Interventions: niraparib, Physician's choice; Drug
Lead sponsor: Tesaro, Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 216 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2021
U.S. locations: 25
States / cities: Tucson, Arizona • Los Angeles, California • Fort Myers, Florida + 20 more

Source: ClinicalTrials.gov public record

Updated Nov 14, 2022 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 1 Interventional

HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

NCT03685331

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Conditions: Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation, BRCA1 Mutation
Interventions: Palbociclib, Olaparib, Fulvestrant; Drug
Lead sponsor: Abramson Cancer Center at Penn Medicine; Other
Eligibility: 18 Years and older · Female only

Enrollment: 9 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2025
U.S. locations: 1
States / cities: Philadelphia, Pennsylvania

Source: ClinicalTrials.gov public record

Updated Jan 8, 2026 · Synced May 21, 2026, 5:34 PM EDT

Terminated Phase 1 Interventional

A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer

NCT05622058

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Conditions: Prevention of Chemotherapy-induced Myelosuppression
Interventions: ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2); Drug
Lead sponsor: Aileron Therapeutics, Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023
U.S. locations: 5
States / cities: Tamarac, Florida • Huntersville, North Carolina • Wilson, North Carolina + 2 more

Source: ClinicalTrials.gov public record

Updated Feb 26, 2023 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 3 Interventional

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521

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Conditions: PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Interventions: RLY-2608, Capivasertib, Fulvestrant; Drug
Lead sponsor: Relay Therapeutics, Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 540 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2031
U.S. locations: 51
States / cities: Gilbert, Arizona • Beverly Hills, California • Duarte, California + 41 more

Source: ClinicalTrials.gov public record

Updated May 7, 2026 · Synced May 21, 2026, 5:34 PM EDT

Active, not recruiting Phase 3 Interventional Results available

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

NCT04915755

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Conditions: Neoplasms, Breast
Interventions: Niraparib, Placebo; Drug
Lead sponsor: GlaxoSmithKline; Industry
Eligibility: 18 Years and older

Enrollment: 40 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2025
U.S. locations: 24
States / cities: Burbank, California • Duarte, California • Palo Alto, California + 20 more

Source: ClinicalTrials.gov public record

Updated Jul 15, 2025 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 1 Interventional

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

NCT06488378

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Conditions: Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Interventions: Axatilimab, Olaparib; Drug
Lead sponsor: Dana-Farber Cancer Institute; Other
Eligibility: 18 Years and older

Enrollment: 20 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2029
U.S. locations: 3
States / cities: Boston, Massachusetts

Source: ClinicalTrials.gov public record

Updated Aug 21, 2025 · Synced May 21, 2026, 5:34 PM EDT

Active, not recruiting Phase 1 Interventional

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

NCT05650879

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Conditions: HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
Interventions: ELVN-002, Fam-Trastuzumab Deruxtecan-Nxki, Trastuzumab emtansine; Drug
Lead sponsor: Enliven Therapeutics; Industry
Eligibility: 18 Years and older

Enrollment: 198 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2026
U.S. locations: 5
States / cities: Aurora, Colorado • Orlando, Florida • Plantation, Florida + 2 more

Source: ClinicalTrials.gov public record

Updated Jul 14, 2025 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 3 Interventional

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

NCT05696626

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Conditions: Metastatic Breast Cancer
Interventions: Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib; Drug
Lead sponsor: LeonaBio; Industry
Eligibility: 18 Years and older

Enrollment: 500 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2028
U.S. locations: 36
States / cities: Scottsdale, Arizona • Tucson, Arizona • Santa Rosa, California + 25 more

Source: ClinicalTrials.gov public record

Updated Apr 20, 2026 · Synced May 21, 2026, 5:34 PM EDT

Terminated Phase 2 Interventional

Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

NCT03318939

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Conditions: NSCLC
Interventions: Poziotinib; Drug
Lead sponsor: Spectrum Pharmaceuticals, Inc; Industry
Eligibility: 18 Years and older

Enrollment: 648 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2023
U.S. locations: 43
States / cities: Phoenix, Arizona • Arcadia, California • Duarte, California + 37 more

Source: ClinicalTrials.gov public record

Updated Apr 2, 2024 · Synced May 21, 2026, 5:34 PM EDT

Suspended Not applicable Interventional

Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)

NCT02993068

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Conditions: BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, Estrogen Receptor Negative, HER2/Neu Negative, MLH1 Gene Mutation, MSH2 Gene Mutation, MSH6 Gene Mutation, PALB2 Gene Mutation, PMS2 Gene Mutation, Progesterone Receptor Negative, RAD51C Gene Mutation, RAD51D Gene Mutation, Triple-Negative Breast Carcinoma
Interventions: Educational Intervention, Genetic Counseling, Laboratory Biomarker Analysis, Questionnaire Administration; Other
Lead sponsor: M.D. Anderson Cancer Center; Other
Eligibility: 30 Years and older · Female only

Enrollment: 5,200 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2026
U.S. locations: 2
States / cities: Houston, Texas • Seattle, Washington

Source: ClinicalTrials.gov public record

Updated Feb 18, 2026 · Synced May 21, 2026, 5:34 PM EDT

Withdrawn Phase 1 Interventional Accepts healthy volunteers

ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer

NCT04602117

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Conditions: HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985, Vic-trastuzumab Duocarmazine, Metastatic Cancer, Metastatic Breast Cancer, Metastatic Gastrointestinal Carcinoid Tumor, Metastatic, HER2 Low Breast Cancer, GastroEsophageal Cancer, Gastroesophageal Adenocarcinoma, Endometrium Tumor, Ovarian Cancer, Ovarian Carcinoma, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, HER2 Mutation-Related Tumors, HER-2 Protein Overexpression, HER2 Low HR Positive, HR Positive, Hormone Receptor-positive Breast Cancer, Estrogen Receptor Positive Tumor, Progesterone Receptor-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Negative Breast Carcinoma, Bladder Cancer
Interventions: Vic-trastuzumab duocarmazine (SYD985) + paclitaxel; Drug
Lead sponsor: QuantumLeap Healthcare Collaborative; Other
Eligibility: 18 Years and older

Healthy volunteers: Accepts healthy volunteers
Timeline: 2021
U.S. locations: 1
States / cities: Aurora, Colorado

Source: ClinicalTrials.gov public record

Updated Nov 17, 2023 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 2 Interventional Results available

Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors

NCT02401347

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Conditions: Advanced Breast Cancer, HER2/Neu Negative, Triple-Negative Breast Cancer
Interventions: Talazoparib Tosylate; Drug
Lead sponsor: Melinda Telli; Other
Eligibility: 18 Years and older

Enrollment: 21 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2015 – 2022
U.S. locations: 1
States / cities: Stanford, California

Source: ClinicalTrials.gov public record

Updated Feb 20, 2023 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 1Phase 2 Interventional

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

NCT03602079

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Conditions: HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer, Salivary Gland Cancer, Salivary Gland Tumor, Salivary Gland Carcinoma, Salivary Gland Neoplasms, Lung Cancer, Colo-rectal Cancer, Rare Diseases, Solid Tumor, Recurrent Gastric Cancer, Recurrent Colon Cancer, Recurrent Breast Cancer, Head and Neck Cancer, Head and Neck Carcinoma, Bladder Cancer, Cervical Cancer, Liver Cancer, Bile Duct Cancer, Urologic Cancer, Pancreatic Cancer, Prostate Cancer, Recurrent Prostate Cancer, Rectal Cancer, Recurrent Ovarian Carcinoma, Recurrent Renal Cell Cancer, Rectal Cancer Stage II, Rectal Cancer Stage I, Rectal Cancer Stage III, Skin Cancer, Mouth Cancer, Lip Cancer Stage I, Tongue Cancer, Breast Neoplasm Malignant Primary, Larynx Cancer, Tonsil Cancer, Palate Cancer, Mucoepidermoid Carcinoma, Primary Peritoneal Carcinoma, Mucinous Adenocarcinoma Gastric, Mucinous Breast Cancer Recurrent, Cholangiocarcinoma
Interventions: A166; Drug
Lead sponsor: Klus Pharma Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 49 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2022
U.S. locations: 10
States / cities: Sarasota, Florida • Boston, Massachusetts • Detroit, Michigan + 7 more

Source: ClinicalTrials.gov public record

Updated Aug 2, 2023 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 3 Interventional Results available

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

NCT02000622

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Conditions: Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Interventions: Olaparib, Physician's choice chemotherapy; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years to 99 Years

Enrollment: 302 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2025
U.S. locations: 42
States / cities: San Diego, California • Santa Rosa, California • Whittier, California + 35 more

Source: ClinicalTrials.gov public record

Updated Feb 12, 2026 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 1 Interventional

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

NCT05681780

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Conditions: Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer
Interventions: Tumor-infiltrating Lymphocytes (TIL), Nivolumab, Cyclophosphamide, Fludarabine, Tumor-infiltrating Lymphocyte Therapy, Interleukin-2 (IL2); Biological · Drug · Other
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute; Other
Eligibility: 18 Years and older

Enrollment: 20 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2027
U.S. locations: 1
States / cities: Tampa, Florida

Source: ClinicalTrials.gov public record

Updated Mar 30, 2026 · Synced May 21, 2026, 5:34 PM EDT

Terminated Phase 1 Interventional

A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

NCT03410927

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Conditions: Advanced Solid Tumors With HER2 Abnormalities, Advanced Solid Tumors With HER3 Abnormalities
Interventions: TAS0728; Drug
Lead sponsor: Taiho Oncology, Inc.; Industry
Eligibility: 18 Years and older

Enrollment: 19 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2022
U.S. locations: 5
States / cities: Duarte, California • Atlanta, Georgia • New York, New York + 2 more

Source: ClinicalTrials.gov public record

Updated Sep 4, 2024 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants

NCT06378658

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Conditions: Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
Interventions: BAY2927088, Esomeprazole, Food; Drug · Other
Lead sponsor: Bayer; Industry
Eligibility: 18 Years to 55 Years

Enrollment: 21 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2024
U.S. locations: 1
States / cities: Baltimore, Maryland

Source: ClinicalTrials.gov public record

Updated Jul 4, 2024 · Synced May 21, 2026, 5:34 PM EDT

Withdrawn Phase 2 Interventional

ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)

NCT05041972

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Conditions: HER2 Mutation-Related Tumors, HER2 Amplified Solid Tumors
Interventions: ARX788; Drug
Lead sponsor: Ambrx, Inc.; Industry
Eligibility: 18 Years and older

Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2022
U.S. locations: 2
States / cities: Miami Beach, Florida • Kansas City, Missouri

Source: ClinicalTrials.gov public record

Updated Sep 12, 2022 · Synced May 21, 2026, 5:34 PM EDT

Completed Phase 3 Interventional

Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy

NCT04447118

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Conditions: Non-squamous NSCLC, HER2 Exon 20 Mutation
Interventions: Pyrotinib, Docetaxel; Drug
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.; Industry
Eligibility: 18 Years and older

Enrollment: 151 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2024
U.S. locations: 11
States / cities: Orange, California • Sacramento, California • Whittier, California + 8 more

Source: ClinicalTrials.gov public record

Updated Dec 18, 2025 · Synced May 21, 2026, 5:34 PM EDT

Recruiting Phase 2 Interventional

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

NCT07222215

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Conditions: Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, HER2- Breast Cancer, ESR1 Gene Mutation, ER Wildtype, Breast Neoplasms
Interventions: Capecitabine, Elacestrant; Drug
Lead sponsor: Kristina A. Fanucci; Other
Eligibility: 18 Years and older

Enrollment: 297 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 1
States / cities: Boston, Massachusetts

Source: ClinicalTrials.gov public record

Updated Jan 21, 2026 · Synced May 21, 2026, 5:34 PM EDT