Clinical trials: HER2-Positive Early Breast Cancer
HER2-positive Breast Cancer
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.
- Trial name
- GeparPiPPa (NCT05306041)
- Testing
- Inavolisib, PHESGO, Endocrine therapy
- Where
- 62 sites in Germany, Italy and 4 more
- Volunteers
- 170 people
- Sponsor
- GBG Forschungs GmbH
ER+ Breast Cancer, HER2-negative Breast Cancer
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy.
- Trial name
- TRAK-ER (NCT04985266)
- Testing
- Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen
- Where
- 49 sites in France, United Kingdom
- Volunteers
- 1,100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
ER-positive Her2-negative Early Breast Cancer
Assessment of Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in ER-positive, Her2-negative Early Breast Cancer
The need/benefit of adjuvant chemotherapy could be negligible for a certain category of patient with newly diagnosed unilateral non metastatic breast cancer.
- Trial name
- OPTIGEN (NCT03080428)
- Testing
- Genomic test
- Sponsor
- UNICANCER
Breast Cancer
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus…
- Trial name
- PREcoopERA (NCT05896566)
- Testing
- Giredestrant, Triptorelin, Anastrozole
- Where
- 37 sites in France, Germany and 4 more
- Volunteers
- 231 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer (Early Breast Cancer)
ADC Based Therapy Accroding to HER2 Heterogeneous
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and…
- Trial name
- HER2level (NCT07844018)
- Testing
- HER2 target therapy
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Peking University People's Hospital
HER2-positive Breast Cancer
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
To evaluate the pathology complete response rate (pathology Complete Response, pCR) of eribulin combined with trastuzumab + pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer.
- Trial name
- NCT05945368
- Testing
- Eribulin mesylate injection、Pertuzumab、Trastuzumab
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer Stage I, Breast Cancer Stage II
A Study of the TheraBionic P1 Device in Breast Cancer
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect…
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA, Hormone Receptor Positive Tumor
- Trial name
- NCT07218432
- Testing
- TheraBionic P1 Device
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Breast Cancer
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer, Locally Advanced Breast Cancer
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic…
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer
- Trial name
- NCT06220214
- Testing
- CEDM, CEDBT, Omnipaque 350mgI/mL Solution for Injection
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alison Stopeck
Breast Cancer, HER2-low-expressing Breast Cancer
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR…
- Conditions
- Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
- Trial name
- NCT05165225
- Testing
- Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer Female
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study.
- Trial name
- ADAPTlate (NCT04565054)
- Testing
- Abemaciclib 50 MG; 150mg 1-0-1 per os
- Where
- 85 sites in Germany, Poland and 1 more
- Volunteers
- 1,260 people
- Sponsor
- Women's Cancer Study Group GmbH
HER2 Positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.
This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2…
- Trial name
- NCT03947242
- Testing
- Pyrotinib and Trastuzumab plus Vinorelbine
- Volunteers
- 48 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early…
- Trial name
- NCT00964704
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda], docetaxel
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy (PHARE-C)
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (< 3 cm) without axillary lymph node involvement or small (< 2 cm) with minimal lymph node involvement (1 positive node)…
- Trial name
- PHARE-C (NCT05388500)
- Testing
- Paclitaxel + Trastuzumab, Trastuzumab
- Volunteers
- 800 people
- Sponsor
- Institut de cancérologie Strasbourg Europe
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Neoplasms, Breast
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone…
- Trial name
- ALTTO (NCT00490139)
- Testing
- Lapatinib, Trastuzumab
- Where
- 924 sites in United States, Argentina and 42 more
- Volunteers
- 8,381 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
Early-stage HER2+ Breast Cancer
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).
- Trial name
- Close2HER (NCT07527741)
- Where
- 10 sites in Serbia
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer
Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment…
- Trial name
- NCT04665986
- Testing
- Navelbine, Docetaxel
- Volunteers
- 50 people
- Sponsor
- Zhejiang Cancer Hospital