Clinical trials: HER2-positive Early-stage Breast Cancer
HER2 Positive Breast Cancer, Cardiovascular Abnormalities
A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging
The Cardio-Oncology program at Northwestern offers care to cancer patients who develop cardiac toxicities from chemotherapy. Breast cancer patients with the tumor marker for HER2 necessitate treatment with anthracycline and/or…
- Trial name
- NCT02993198
- Testing
- Carvedilol
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Northwestern University
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Breast Cancer
A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This non-randomized, multicenter, open-label study will assess the safety and efficacy of subcutaneously administered trastuzumab in participants with early and locally advanced HER2-positive breast cancer in two sequential…
- Trial name
- SCHEARLY (NCT01940497)
- Testing
- Doxorubicin, Docetaxel, Paclitaxel
- Where
- 54 sites in Italy
- Volunteers
- 240 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
This is a prospective, open label, single-arm study to evaluate the efficacy and safety of neoadjuvant pyrotinib in HER2+ breast cancer patients
- Trial name
- NCT04290793
- Testing
- Pyrotinib, Epirubicin, Cyclophosphamide
- Where
- China
- Volunteers
- 113 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer
Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with Non-pegylated liposomal doxorubicin (NPLD; Myocet…
- Trial name
- LAPADO (NCT01172223)
- Testing
- Myocet (Non-pegylated liposomal doxorubicin (NPLD)), Paclitaxel, Lapatinib (GW572016, Tykerb)
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Prof Dirk Elling
Breast Cancer
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
- Trial name
- NCT04066790
- Testing
- Pyrotinib, nab-Paclitaxel, Trastuzumab
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Cancer
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by…
- Trial name
- IMpassion050 (NCT03726879)
- Testing
- Atezolizumab, Doxorubicin, Cyclophosphamide
- Where
- 76 sites in United States, Brazil and 10 more
- Volunteers
- 454 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Triple Negative Breast Neoplasms
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency.
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, HRpos Breast Neoplasms, BRCA 1 /2 and / or HRD
- Trial name
- GeparOla (NCT02789332)
- Testing
- PwO, PwCb, EC
- Where
- 12 sites in Germany
- Volunteers
- 107 people
- Sponsor
- GBG Forschungs GmbH
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSepto (NCT01583426)
- Testing
- nab-Paclitaxel, Paclitaxel
- Where
- Germany
- Volunteers
- 1,229 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients.
- Trial name
- Cinderella (NCT07213206)
- Testing
- CDK 4/6 inhibitor combined therapy (omit chemo), standard of care
- Volunteers
- 1,500 people
- Sponsor
- Fudan University
Triple Negative Breast Cancer, HER2-negative Breast Cancer
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast…
- Trial name
- DecipHER (NCT05504707)
- Testing
- HER2 - primed Dendritic cells, HER3 - primed Dendritic cells
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive…
- Trial name
- NCT00976989
- Testing
- Pertuzumab, Trastuzumab, FEC
- Where
- 55 sites in Bosnia and Herzegovina, Brazil and 18 more
- Volunteers
- 225 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT07407920
- Testing
- Biospecimen Collection, Hormone Therapy, Pembrolizumab
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer.
- Conditions
- Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT04553770
- Testing
- Anastrozole, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan
- Where
- 9 sites in United States
- Volunteers
- 88 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
HER-2 Positive Breast Cancer, Breast Cancer
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2.
- Conditions
- HER-2 Positive Breast Cancer, Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Trial name
- NCT02326974
- Testing
- T-DM1, Pertuzumab, Excision of tumor/mastectomy
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Dana-Farber Cancer Institute
Early Breast Cancer, HER2 + Breast Cancer
SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen.
- Conditions
- Early Breast Cancer, HER2 + Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Trial name
- NCT07129187
- Testing
- SHR-A1811
- Volunteers
- 30 people
- Sponsor
- Chuan Wang