Clinical trials: HER2-positive Advanced Breast Cancer
Breast Cancer, Breast Cancer, Male
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with…
- Conditions
- Breast Cancer, Breast Cancer, Male, Breast Cancer Female, HER2-positive Breast Cancer
- Trial name
- NCT03112590
- Testing
- Interferon-gamma (IFN-γ), Paclitaxel, Trastuzumab
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
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 Neoplasms
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast…
- Trial name
- NCT00826267
- Testing
- lapatinib, BIBW 2992, trastuzumab
- Where
- 17 sites in United States, Brazil and 2 more
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without…
- Trial name
- NCT01480674
- Testing
- Trastuzumab
- Where
- 78 sites in France
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00796978
- Testing
- trastuzumab, laboratory biomarker analysis, adjuvant therapy
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cynthia Owusu, MD
Breast Cancer
Agatolimod and Trastuzumab in Treating Patients With Locally Advanced or Metastatic Breast Cancer
RATIONALE: Biological therapies, such as agatolimod, may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways.
- Trial name
- NCT00824733
- Testing
- Trastuzumab, PF03512676, Correlative Studies
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Bhuvaneswari Ramaswamy
Hormone Receptor Positive Breast Cancer
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2…
- Trial name
- BOLERO-4 (NCT01698918)
- Testing
- Everolimus, Letrozole, Exemestane
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and…
- Trial name
- NCT01998906
- Testing
- Trastuzumab, Doxorubicin, Paclitaxel
- Where
- 36 sites in Austria, Germany and 4 more
- Volunteers
- 330 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Hormone Receptor Positive HER-2 Negative Breast Cancer
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
- Trial name
- PALINA (NCT02692755)
- Testing
- Palbociclib + Letrozole or Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Georgetown University
Bone Metastases, HER2-positive Breast Cancer
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in…
- Conditions
- Bone Metastases, HER2-positive Breast Cancer, Liver Metastases, Lung Metastases
- Trial name
- NCT02226276
- Testing
- fludeoxyglucose F 18, positron emission tomography, computed tomography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- City of Hope Medical Center
Breast Cancer, Metastasis
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
- Trial name
- NCT00371345
- Testing
- Dasatinib, Dasatinib 100 mg
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 92 people
- Sponsor
- Bristol-Myers Squibb
HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen…
- Conditions
- HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7
- Trial name
- NCT02003209
- Testing
- Aromatase Inhibition Therapy, Carboplatin, Cytology Specimen Collection Procedure
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 315 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery.
- Trial name
- NCT02520063
- Testing
- Letrozole, Everolimus, TRC105
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Alabama at Birmingham
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative
- Trial name
- NCT02115282
- Testing
- Biospecimen Collection, Computed Tomography, Entinostat
- Where
- 653 sites in United States, South Africa
- Volunteers
- 608 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer
Panacea is a phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2- positive metastatic breast cancers
- Trial name
- PANACEA (NCT02129556)
- Testing
- MK-3475
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 58 people
- Sponsor
- ETOP IBCSG Partners Foundation