Clinical trials: HER2 Negative Breast Cancer
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage…
- Trial name
- NCT04629846
- Testing
- Trastuzumab, QL1209, Pertuzumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved.
- Conditions
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor Positive Breast Cancer
- Trial name
- NCT03854903
- Testing
- Palbociclib, Bosutinib, Fulvestrant
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Georgetown University
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer
Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery
This phase II trial is studying how well giving entinostat and anastrozole together works in treating postmenopausal women with triple-negative breast cancer that can be removed by surgery.
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage I Breast Cancer
- Trial name
- 0927GCC (NCT01234532)
- Testing
- entinostat, anastrozole, diagnostic laboratory biomarker analysis
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Maryland, Baltimore
Breast Cancer
A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Breast Cancer After Adjuvant Therapy
The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast cancer.
- Trial name
- NCT01152398
- Testing
- MVA-BN-HER2
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Bavarian Nordic
Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
- Trial name
- DUET-3 (NCT03752398)
- Testing
- XmAb®23104, Yervoy® (ipilimumab)
- Where
- 18 sites in United States
- Volunteers
- 198 people
- Sponsor
- Xencor, Inc.
Breast Cancer
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
- Trial name
- CADENCE (NCT02547987)
- Testing
- Docetaxel, Carboplatin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Mothaffar Rimawi
HER2-negative Metastatic Breast Cancer, HER2-positive Circulating Tumor Cells
DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs
The HER2 status in breast cancer patients may change during the course of the disease. In 30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs can be detected in peripheral blood…
- Trial name
- DETECT III (NCT01619111)
- Testing
- standard chemo- or endocrine therapy, standard chemo- or endocrine therapy + Lapatinib
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- Prof. Wolfgang Janni
Breast Diseases, Breast Neoplasms
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2…
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases
- Trial name
- NCT07581834
- Testing
- Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- 2 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Fujian Cancer Hospital
Breast Neoplasms, Breast Cancer
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Carcinoma, Genes
- Trial name
- NCT06125314
- Where
- 7 sites in Kuwait, Qatar and 2 more
- Volunteers
- 517 people
- Sponsor
- AstraZeneca
Breast Cancer
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node…
- Trial name
- NCT06996093
- Testing
- 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
- Where
- China
- Volunteers
- 2,508 people
- Sponsor
- Fudan University
Invasive Breast Cancer (Stage I-III)
Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer
The goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human…
- Trial name
- NCT07801898
- Testing
- NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- The Second Hospital of Anhui Medical University
Hormone Receptor-Positive Male Breast Cancer
Divergent Long-Term Clinical Courses in Two Men With Breast Cancer
This observational study describes the long-term clinical courses of two men with hormone receptor-positive, HER2-negative invasive breast cancer.
- Trial name
- NCT07865507
- Testing
- Follow-up
- Where
- Azerbaijan
- Volunteers
- 2 people
- Sponsor
- Azerbaijan Medical University
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
This study will examine if a short-term, reduced protein diet for the 3-day period prior to and on the day of each of the first 4 chemotherapy cycles and 4 days prior to primary breast surgery is well tolerated and adhered to by…
- Trial name
- NCT07897344
- Testing
- Dietary Protein Intervention
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Josephine Connolly-Schoonen
Breast Cancer
BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab
The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.
- Trial name
- BETH (NCT00625898)
- Testing
- Docetaxel, Trastuzumab, Carboplatin
- Where
- 649 sites in United States, Argentina and 38 more
- Volunteers
- 3,509 people
- Sponsor
- NSABP Foundation Inc
Breast Cancer, Metastasis
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- Trial name
- NCT05095207
- Testing
- Abemaciclib, Bicalutamide
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05216432
- Testing
- RLY-2608, Fulvestrant, Palbociclib 125mg
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 930 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer, Ovarian Cancer
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in…
- Conditions
- Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT05905341
- Testing
- PF-07224826, Fulvestrant
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
- Trial name
- NCT03703466
- Testing
- Abemaciclib
- Where
- 15 sites in Australia, Belgium and 3 more
- Volunteers
- 72 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Apatinib Combined With Oral Etoposide in Metastatic HER2 Negative Breast Cancer
The hypothesis of this study is to discover if the all-oral therapy with apatinib plus oral Etoposide can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.
- Trial name
- NCT03535961
- Testing
- apatinib+oral etoposide
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Chinese Academy of Medical Sciences
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
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