Clinical trials: Early Stage Breast Cancer
Chemotherapy Adjuvant, Breast Cancer
Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia
The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens.
- Trial name
- NCT01831024
- Testing
- Dignicap System
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Target Health Inc.
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve…
- Trial name
- PEONY (NCT02586025)
- Testing
- FEC Chemotherapy, Surgery, Docetaxel
- Where
- 23 sites in China, South Korea and 2 more
- Volunteers
- 329 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer
The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
- Trial name
- Lilac (NCT01901146)
- Testing
- ABP 980, Trastuzumab, Paclitaxel
- Where
- 98 sites in Belarus, Brazil and 16 more
- Volunteers
- 725 people
- Sponsor
- Amgen
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive…
- Trial name
- NCT01196052
- Testing
- Trastuzumab emtansine
- Where
- 44 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage…
- Trial name
- NCT04629846
- Testing
- Trastuzumab, QL1209, Pertuzumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
Breast Cancer
Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems.
- Trial name
- OlympiaN (NCT05498155)
- Testing
- Neoadjuvant Olaparib monotherapy group, Neoadjuvant combination therapy with olaparib plus durvalumab
- Where
- 36 sites in United States, Australia and 7 more
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.
- Trial name
- TAMARA (NCT00784888)
- Testing
- Aromatase inhibitors
- Where
- 16 sites in Turkey (Türkiye)
- Volunteers
- 344 people
- Sponsor
- Pfizer
HER2 + Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Trial name
- NCT07601620
- Testing
- HLX319, EU-Phesgo®
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative…
- Trial name
- ELEGANT (NCT06492616)
- Testing
- Elacestrant, Anastrozole, Letrozole
- Where
- 567 sites in United States, Argentina and 26 more
- Volunteers
- 4,220 people
- Sponsor
- Stemline Therapeutics, Inc.
Early Breast Cancer (Phase 2), Advanced Breast Cancer (Phase 1b)
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and…
- Trial name
- NCT01430585
- Testing
- PF-04691502, PF-04691502 in combination with Letrozole, Letrozole
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 14 people
- Sponsor
- Pfizer
Breast Cancer
ctDNA Monitoring in Early Breast Cancer
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.
- Trial name
- NCT04353557
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Geneplus-Beijing Co. Ltd.
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products
Breast Cancer, Metastatic, Breast Cancer Invasive
Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.
- Conditions
- Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Trial name
- PROBE-CTC (NCT06807502)
- Testing
- The DM/DIV ScreenCell is the experimental product studied during this research
- Where
- France
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- ScreenCell
Breast Cancer
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast…
- Trial name
- NCT01077154
- Testing
- Denosumab
- Where
- 459 sites in United States, Argentina and 37 more
- Volunteers
- 4,509 people
- Sponsor
- Amgen
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, Recurrence
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC).
- Trial name
- NCT03772197
- Where
- Taiwan
- Volunteers
- 138 people
- Sponsor
- Amwise Diagnostics Pte. Ltd.
Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS
Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on…
- Trial name
- SHIELD (NCT07711847)
- Testing
- VENUS SHELL™ immobilization device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HeroSupport SA
Breast Cancer, Breast Neoplasms
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT03556358
- Testing
- TX05 (trastuzumab), Herceptin®, Paclitaxel
- Where
- 146 sites in Belarus, Chile and 8 more
- Volunteers
- 809 people
- Sponsor
- Tanvex BioPharma USA, Inc.
Breast Cancer
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel…
- Trial name
- NCT02301988
- Testing
- Ipatasertib, Paclitaxel
- Where
- 42 sites in United States, Portugal and 1 more
- Volunteers
- 151 people
- Sponsor
- Genentech, Inc.