Clinical trials: HER2- Negative Breast Cancer
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
HER2-negative Breast Cancer Patients With Brain Metastases
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases.
- Trial name
- NCT06764940
- Testing
- Utidelone, Utidelone in combination with capecitabine
- Where
- 12 sites in United States
- Volunteers
- 120 people
- Sponsor
- Biostar Pharma, Inc.
Metastatic Breast Cancer
Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
- Trial name
- NCT00958971
- Testing
- TKI258
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,, Primary Peritoneal Cancer or Endometrial Cancer
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.
- Conditions
- Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,, Primary Peritoneal Cancer or Endometrial Cancer, Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
- Trial name
- NCT01209195
- Testing
- MM-121, Paclitaxel
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- Merrimack Pharmaceuticals
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Melanoma, Renal Cell Carcinoma
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D.
- Conditions
- Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma
- Trial name
- PIVOT-02 (NCT02983045)
- Testing
- Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 557 people
- Sponsor
- Nektar Therapeutics
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Breast Cancer
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative…
- Trial name
- NCT02049957
- Testing
- Sapanisertib, Fulvestrant, Exemestane
- Where
- 40 sites in United States, Belgium and 1 more
- Volunteers
- 118 people
- Sponsor
- Calithera Biosciences, Inc
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics
Early-stage HER2+ Breast Cancer
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).
- Trial name
- Close2HER (NCT07527741)
- Where
- 10 sites in Serbia
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Breast Cancer
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: 1.
- Trial name
- NCT05489679
- Testing
- AC682
- Where
- 3 sites in China
- Volunteers
- 6 people
- Sponsor
- Accutar Biotechnology Inc
Breast Cancer
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
This is a single-arm, open-label, exploratory clinical study
- Trial name
- NCT06613373
- Testing
- Dalpiciclib
- Volunteers
- 30 people
- Sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.
- Conditions
- Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases
- Trial name
- NCT01173497
- Testing
- INIPARIB + irinotecan
- Where
- 13 sites in United States
- Volunteers
- 44 people
- Sponsor
- Sanofi
Breast Cancer
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or…
- Trial name
- MoonROSE (NCT07100106)
- Testing
- GDC-4198, Giredestrant, Abemaciclib
- Where
- 77 sites in United States, Australia and 8 more
- Volunteers
- 285 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer.
- Trial name
- NCT00121836
- Testing
- Capecitabine, Bevacizumab
- Where
- 57 sites in United States
- Volunteers
- 109 people
- Sponsor
- Hoffmann-La Roche
Advanced or Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast…
- Trial name
- DB-06 (NCT04494425)
- Testing
- Trastuzumab deruxtecan, Capecitabine, Paclitaxel
- Where
- 293 sites in United States, Argentina and 26 more
- Volunteers
- 866 people
- Sponsor
- AstraZeneca