Clinical trials: HER-2 Positive Breast Cancer
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)
Solid Tumor
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal…
- Trial name
- MasterKey-01 (NCT04209465)
- Testing
- BDTX-189
- Where
- 38 sites in United States, Denmark and 2 more
- Volunteers
- 91 people
- Sponsor
- Black Diamond Therapeutics, Inc.
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy…
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer
- Trial name
- NCT01293032
- Testing
- Neoadjuvant Therapy, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis
- Where
- 8 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Virginia Commonwealth University
Breast Cancer Metastatic
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic…
- Trial name
- AMEERA-3 (NCT04059484)
- Testing
- Amcenestrant, Fulvestrant, Anastrozole
- Where
- 109 sites in United States, Argentina and 21 more
- Volunteers
- 367 people
- Sponsor
- Sanofi
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Cancer
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of…
- Trial name
- NCT00950300
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 106 sites in Argentina, Brazil and 24 more
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. Palbociclib is a drug that may stop cancer cells from growing.
- Trial name
- NCT02040857
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- 10 sites in United States
- Volunteers
- 162 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Neoplasms
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line…
- Trial name
- PERUSE (NCT01572038)
- Testing
- Docetaxel, Nab-paclitaxel, Paclitaxel
- Where
- 299 sites in Algeria, Argentina and 37 more
- Volunteers
- 1,436 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, Recurrent Breast Cancer
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer.
- Conditions
- HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT00079326
- Testing
- trastuzumab, ixabepilone, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
- Trial name
- MONARCH 1 (NCT02102490)
- Testing
- Abemaciclib
- Where
- 36 sites in United States, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression.
- Trial name
- NCT02291913
- Testing
- Everolimus, Exemestane, Tamoxifen
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- SCRI Development Innovations, LLC
Breast Cancer
A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This two-part study is composed of two stages: a Phase Ib stage consisting of a dose-escalation phase and an expansion phase; and a Phase II, randomized, placebo-controlled, double-blind, multicenter stage.
- Trial name
- NCT04298918
- Testing
- Venetoclax, Trastuzumab emtansine
- Where
- 3 sites in Australia, South Korea
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Stage I Breast Cancer
Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff…
- Trial name
- ELPIS (NCT04578106)
- Testing
- Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Fundacio Clinic Barcelona
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with…
- Trial name
- KATE2 (NCT02924883)
- Testing
- Atezolizumab, Trastuzumab emtansine
- Where
- 68 sites in United States, Australia and 7 more
- Volunteers
- 202 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV)…
- Trial name
- NCT00951665
- Testing
- paclitaxel, pertuzumab [Perjeta], trastuzumab emtansine [Kadcyla]
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
Breast Cancer, Cardiac Toxicity
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.
- Trial name
- NCT01009918
- Testing
- Coreg CR®, lisinopril
- Where
- 174 sites in United States
- Volunteers
- 468 people
- Sponsor
- University of South Florida
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.