Clinical trials: HER-2 Positive Breast Cancer
HER2 + Breast Cancer
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
- Trial name
- NCT07294534
- Testing
- HLX87+HX22, HLX87 + Pertuzumab, TCbHP
- Volunteers
- 817 people
- Sponsor
- Shanghai Henlius Biotech
Locally Advanced or Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human…
- Trial name
- NCT05296798
- Testing
- Phesgo, Giredestrant, Docetaxel
- Where
- 198 sites in United States, Argentina and 27 more
- Volunteers
- 922 people
- Sponsor
- Hoffmann-La Roche
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice.
- Trial name
- NCT01152606
- Testing
- trastuzumab [Herceptin]
- Where
- 205 sites in Austria, Belgium and 7 more
- Volunteers
- 3,942 people
- Sponsor
- Hoffmann-La Roche
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
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12…
- Trial name
- NCT03433313
- Testing
- EG12014, Herceptin
- Where
- 91 sites in United States, Belarus and 9 more
- Volunteers
- 807 people
- Sponsor
- EirGenix, Inc.
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 Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
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
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
HER2-positive Advanced Breast Cancer
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy…
- Trial name
- NCT07047365
- Testing
- TQB2930+ chemotherapy, Trastuzumab+ chemotherapy
- Where
- 75 sites in China
- Volunteers
- 416 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
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
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
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
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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