Clinical trials: Hormone Receptor Positive Malignant Neoplasm of Breast, open to volunteers
Breast Cancer
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Trial name
- TB06 (NCT07205822)
- Testing
- Dato-DXd
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Solid Tumor, Advanced Solid Tumor
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for…
- Conditions
- Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor
- Trial name
- NCT06586957
- Testing
- NKT3964, Paclitaxel, Doxorubicin
- Where
- 21 sites in United States, South Korea
- Volunteers
- 238 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic)
ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population
The goal of this observational study is to assess the prevalence of ESR1 mutations in patients with metastatic hormone receptor-positive/HER2-negative breast cancer in Greece and evaluate the associations of these mutations with…
- Conditions
- ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic), Hormon Receptor Positive Breast Cancer
- Trial name
- ΗΕ 11ESR1/24 (NCT07899463)
- Where
- Greece
- Volunteers
- 500 people
- Sponsor
- Hellenic Cooperative Oncology Group
Breast Cancer (Locally Advanced or Metastatic)
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to compare the objective response rates (ORR) of different doses of BL0175 in patients with postmenopausal hormone receptor (HR)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT07658183
- Testing
- BL0175 Injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Best-Link Bioscience, LLC
Breast Neoplasm, Breast Cancer
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had…
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- NCT05594095
- Testing
- PIK3CA inhibitor, AKT inhibitor, Carrelizumab
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
Breast Cancer, Stage 0 Breast Cancer
A Study of Revaree Plus in People With Breast Cancer
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
- Conditions
- Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT07042581
- Testing
- Revaree Plus
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Breast Neoplasm
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when…
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive
- Trial name
- RESPONSE (NCT05020860)
- Testing
- Paclitaxel, Carboplatin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Baylor Breast Care Center
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Cutaneous Melanoma, Locally Advanced Mucosal Melanoma
- Trial name
- NCT05098210
- Testing
- Neoantigen Peptide Vaccine, Nivolumab, Poly ICLC
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Fred Hutchinson Cancer Center
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04348747
- Testing
- Anti-HER2/HER3 Dendritic Cell Vaccine, Pembrolizumab
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Roswell Park Cancer Institute
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Cervical Cancer, Breast Cancer
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or…
- Conditions
- Cervical Cancer, Breast Cancer, Colon Cancer, NSCLC
- Trial name
- NCT05283330
- Testing
- ²¹²Pb-DOTAM-GRPR1
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Orano Med Theranostics, SAS
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Metastatic (Stage IV) Melanoma
Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.
Although treatments for breast cancer have improved, 20-30% of patients with early disease develop metastases (cancer that spreads to other parts of the body).
- Trial name
- EPIBREAST (NCT07340619)
- Testing
- prifetrastat monotherapy for 15 days then combination with fulvestrant, prifetrastat in combination with fulvestrant
- Where
- 8 sites in France
- Volunteers
- 51 people
- Sponsor
- UNICANCER
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer, Breast Cancer Metastatic
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers.
- Conditions
- Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INX-315-01 (NCT05735080)
- Testing
- INX-315, Fulvestrant, Abemaciclib
- Where
- 18 sites in United States, Australia
- Volunteers
- 150 people
- Sponsor
- Incyclix Bio