Clinical trials: HER2-Positive Breast Cancer
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1…
- Trial name
- NCT01120561
- Testing
- trastuzumab-MCC-DM1
- Where
- 15 sites in United States
- Sponsor
- Genentech, Inc.
Breast Cancer
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer…
- Trial name
- RIBANNA (NCT06311383)
- Testing
- First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
- Where
- 265 sites in Germany
- Volunteers
- 2,610 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
- Trial name
- NCT00696072
- Testing
- Dasatinib, Letrozole
- Where
- 27 sites in United States
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
HER-2 Positive Breast Cancer, Metastatic Breast Cancer
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel.
- Trial name
- NCT00788931
- Testing
- IV LBH589, Oral LBH589, trastuzumab
- Where
- 7 sites in United States, Australia and 3 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer
This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally…
- Trial name
- NCT02402712
- Testing
- Docetaxel, pertuzumab [Perjeta], trastuzumab [Herceptin]
- Where
- 112 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 418 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors.
- Trial name
- NCT07287917
- Testing
- AMXT 1501 Dicaprate, DFMO, Fulvestrant
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Aminex Therapeutics, Inc.
HER2-positive Breast Cancer, HER2-low Breast Cancer
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior…
- Conditions
- HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer, Advanced Cancer
- Trial name
- NCT06210776
- Testing
- Trastuzumab deruxtecan
- Where
- 54 sites in China
- Volunteers
- 800 people
- Sponsor
- Daiichi Sankyo
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
Breast Cancer
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice…
- Trial name
- BOLERO-6 (NCT01783444)
- Testing
- Capecitabine, Exemestane, Everolimus
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 309 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus…
- Trial name
- NCT01120184
- Testing
- docetaxel, paclitaxel, pertuzumab
- Where
- 257 sites in United States, Argentina and 36 more
- Volunteers
- 1,095 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Gastric Cancer
Safety Study of MGAH22 in HER2-positive Carcinomas
The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer.
- Trial name
- NCT01148849
- Testing
- margetuximab
- Where
- 3 sites in United States, South Korea
- Volunteers
- 66 people
- Sponsor
- MacroGenics
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
ALEXANDRIA Study Egypt
Breast Cancer (BC) is one of the most frequent cancers in women and is the most frequent cause of death in the female population.
- Trial name
- NCT03583463
- Where
- 8 sites in Egypt
- Volunteers
- 436 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial…
- Trial name
- NCT00885755
- Testing
- Standard taxane therapy, capecitabine [Xeloda], trastuzumab [Herceptin]
- Where
- 13 sites in Australia, Spain and 2 more
- Volunteers
- 33 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC).
- Trial name
- NCT01615068
- Where
- 142 sites in United States
- Volunteers
- 1,007 people
- Sponsor
- Genentech, Inc.
Early-stage or Locally Advanced HER2-positive Breast Cancer
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial…
- Trial name
- NCT07196774
- Testing
- SHR-A1811 for Injection, Docetaxel injection, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 740 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free…
- Trial name
- BOLERO-3 (NCT01007942)
- Testing
- everolimus, vinorelbine, trastuzumab
- Where
- 161 sites in United States, Argentina and 19 more
- Volunteers
- 569 people
- Sponsor
- Novartis Pharmaceuticals