Clinical trials: HER2 Positive Metastatic Breast Cancer
Metastatic Breast Cancer
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous…
- Trial name
- NCT00928330
- Testing
- GDC-0941, Trastuzumab, trastuzumab-MCC-DM1
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
This phase II trial studies how well mirvetuximab soravtansine works as first line in treating patients with triple negative breast cancer.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Trial name
- NCT03106077
- Testing
- Mirvetuximab Soravtansine
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Metastatic, Metastatic Breast Cancer
Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II
The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer.
- Trial name
- AVATARII (NCT06882499)
- Testing
- Stereotactic Ablative Radiotherapy, Physician's choice of systemic treatment
- Volunteers
- 74 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT07112053
- Testing
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Capecitabine, Computed Tomography
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Metastatic Breast Cancer
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national…
- Trial name
- NCT05132101
- Testing
- Patients who received Palbociclib as first line therapy in MBC setting
- Where
- South Korea
- Volunteers
- 2,758 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2…
- Trial name
- VinoMetro (NCT03007992)
- Testing
- Vinorelbine
- Where
- 8 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Johannes Gutenberg University Mainz
Early Breast Cancer, Metastatic Breast Cancer
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
- Conditions
- Early Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- RosHER (NCT05217381)
- Where
- 7 sites in Spain
- Volunteers
- 18,533 people
- Sponsor
- MedSIR
Breast, Neoplasm Malignant
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients.
- Conditions
- Breast, Neoplasm Malignant, Female
- Trial name
- NCT04524728
- Testing
- Palbociclib, Letrozole 2.5mg, Fulvestrant
- Where
- Italy
- Volunteers
- 191 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of alpelisib when given together with enzalutamide in treating patients with androgen receptor and PTEN positive breast cancer that has spread to other places in the body.
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT03207529
- Testing
- Alpelisib, Enzalutamide
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- M.D. Anderson Cancer Center
HER2-positive Breast Cancer
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had…
- Trial name
- NCT06316531
- Testing
- BL-M07D1, T-DM1
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and…
- Trial name
- NCT01674062
- Testing
- Pertuzumab, Trastuzumab
- Where
- 20 sites in Canada, France and 3 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Metastatic Breast Cancer
A Study of Pyrotinib Plus Vinorelbine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or…
- Trial name
- NCT03997539
- Testing
- Pyrotinib, Treatment of physician's choice, vinorelbine
- Volunteers
- 256 people
- Sponsor
- Sun Yat-sen University
HER2-positive Breast Cancer
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 +…
- Trial name
- REVER (NCT03619044)
- Testing
- 2 FES-PET Imaging will be performed:
- Where
- 6 sites in France
- Volunteers
- 4 people
- Sponsor
- Institut Claudius Regaud
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Metastatic Breast Cancer
Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer
This is a prospective, single-arm, multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive, ER-Positive metastatic breast cancer.
- Trial name
- NCT04407988
- Testing
- Pyrotinib Maleate plus Letrozole
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Hunan Cancer Hospital
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc