Clinical trials: HER2 Positive Breast Cancer
HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without…
- Conditions
- HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer
- Trial name
- NCT02605915
- Testing
- Atezolizumab, Carboplatin, Docetaxel
- Where
- 20 sites in United States
- Volunteers
- 98 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label…
- Trial name
- NCT03671330
- Testing
- Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin
- Where
- 24 sites in China
- Volunteers
- 327 people
- Sponsor
- Novartis Pharmaceuticals
HER2 Positive Breast Cancer
A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients
In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
- Trial name
- TROIKA (NCT03013504)
- Testing
- HD201, Herceptin, Docetaxel
- Where
- 15 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 503 people
- Sponsor
- Prestige Biopharma Limited
Breast Cancer, Adjuvant Therapy
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in…
- Conditions
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- Trial name
- NEAR (NCT05599334)
- Where
- 25 sites in Belgium, Croatia and 3 more
- Volunteers
- 111 people
- Sponsor
- Pierre Fabre Medicament
HER2-expressing Cancers
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety…
- Trial name
- NCT03821233
- Testing
- ZW49
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 112 people
- Sponsor
- Zymeworks BC Inc.
Breast Cancer
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant…
- Trial name
- BERENICE (NCT02132949)
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 80 sites in United States, Canada and 10 more
- Volunteers
- 401 people
- Sponsor
- Hoffmann-La Roche
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
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
- Trial name
- CONTRAST (NCT05555251)
- Testing
- BI-1607, Trastuzumab
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- BioInvent International AB
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2).
- Trial name
- NCT06188559
- Testing
- BB-1701
- Where
- 49 sites in United States, France and 2 more
- Volunteers
- 56 people
- Sponsor
- Eisai Inc.
Breast Cancer
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast…
- Trial name
- NCT06954961
- Testing
- D-0502, Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 640 people
- Sponsor
- InventisBio Co., Ltd
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
HER2-PositiveRecurrent or Metastatic Breast Cancer
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
- Trial name
- NCT06057610
- Testing
- SHR-A1811 Injection, SHR-A1811 Injection ； Pertuzumab Injection, Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection
- Where
- China
- Volunteers
- 868 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Recurrent / Metastatic Breast Cancer
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects.
- Trial name
- NCT05252546
- Testing
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Advanced Breast Cancer, HER2-positive Breast Cancer
A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with…
- Trial name
- ATTILA (NCT03811418)
- Testing
- Trastuzumab, Pertuzumab, Vinorelbine
- Where
- Germany
- Sponsor
- iOMEDICO AG
Breast Cancer
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This was a Phase 1/2 dose escalation and cohort expansion study and assessed the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in participants with estrogen receptor…
- Trial name
- mBC (NCT04072952)
- Testing
- Vepdegestrant, Palbociclib
- Where
- 16 sites in United States
- Volunteers
- 219 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.
Breast Cancer
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or…
- Trial name
- NCT00712881
- Testing
- Liposomal doxorubicin hydrochloride, Cyclophosphamide, Trastuzumab
- Where
- 22 sites in Austria, Belgium and 4 more
- Volunteers
- 126 people
- Sponsor
- Cephalon, Inc.
Breast Cancer
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with…
- Trial name
- AMEERA-2 (NCT03816839)
- Testing
- Amcenestrant (SAR439859)
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Sanofi
HER2 Positive Breast Cancer
Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer
The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast…
- Trial name
- NCT02476539
- Testing
- Hemay022
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd