Clinical trials: HER2 + Breast Cancer
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal…
- Trial name
- TROPiCS-02 (NCT03901339)
- Testing
- Sacituzumab Govitecan-hziy, Eribulin, Capecitabine
- Where
- 113 sites in United States, Belgium and 7 more
- Volunteers
- 543 people
- Sponsor
- Gilead Sciences
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast…
- Trial name
- NCT02144012
- Testing
- Trastuzumab, Trastuzumab Emtansine, Docetaxel
- Where
- 8 sites in Malaysia, South Korea and 2 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
ER Reactivation Therapy for Breast Cancer
Before anti-estrogens such as tamoxifen were developed to treat estrogen receptor (ER)-positive breast cancer, high-dose estrogen therapies were used.
- Trial name
- POLLY (NCT02188745)
- Testing
- 17B-estradiol, Letrozole, Anastrozole
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
Testing the Effects of Palbociclib and Fulvestrant or Letrozole for Patients 70 Years of Age of Older With Metastatic Breast Cancer
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03633331
- Testing
- Palbociclib, Letrozole, Fulvestrant
- Where
- 447 sites in United States
- Volunteers
- 93 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Cancer
Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Diarrhoea is the most commonly reported adverse event (AE) associated with Lapatinib treatment, and is also commonly associated with Capecitabine treatment.
- Trial name
- NCT02294786
- Testing
- Lapatinib, Capecitabine, Octreotide
- Where
- 17 sites in Czechia, Israel and 3 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer.
- Trial name
- PrefHER (NCT01401166)
- Testing
- Herceptin, Single-Use Injection Device
- Where
- 75 sites in Canada, Denmark and 10 more
- Volunteers
- 488 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after…
- Trial name
- NCT01528345
- Testing
- Dovitinib, Fulvestrant
- Where
- 67 sites in United States, Argentina and 13 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment…
- Trial name
- FORTRESS (NCT03786094)
- Testing
- Eribulin, Balixafortide
- Where
- 88 sites in United States, Argentina and 11 more
- Volunteers
- 432 people
- Sponsor
- Spexis AG
Breast Cancer
Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells.
- Trial name
- NCT00971737
- Testing
- allogeneic GM-CSF-secreting breast cancer vaccine, trastuzumab, cyclophosphamide
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth…
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT02827877
- Testing
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
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
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Breast Cancer, Brain Metastasis
T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery
Background: Sometimes breast cancer spreads (metastasizes) to the brain. Researchers want to study new treatments for brain metastases. The drug Temozolomide is approved to treat brain tumors.
- Conditions
- Breast Cancer, Brain Metastasis, Brain Cancer
- Trial name
- NCT03190967
- Testing
- T-DM1, TMZ
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Neoplasms, Breast
Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC).
- Trial name
- NCT00709761
- Testing
- Lapatinib/nab-Paclitaxel
- Where
- 13 sites in United States
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, HER2-negative Breast Cancer
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast…
- Trial name
- NCT01705691
- Testing
- Paclitaxel, Eribulin, Doxorubicin
- Where
- 20 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- NSABP Foundation Inc
Breast Cancer
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard…
- Trial name
- NCT01593020
- Testing
- Paclitaxel, Eribulin, 5-Fluorouracil
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- M.D. Anderson Cancer Center