Clinical trials: HER2-negative Early Breast Cancer
Breast Cancer, ER-positive Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC).
- Conditions
- Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05826964
- Testing
- AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Miami
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Study participants with primary breast cancer will receive a standard chemotherapy with an anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses and duration in concordance to current…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSixto (NCT01426880)
- Testing
- Carboplatin, background treatment
- Where
- 3 sites in Germany
- Volunteers
- 595 people
- Sponsor
- GBG Forschungs GmbH
Early Breast Cancer
This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.
Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Trial name
- PRIORITY (NCT07309887)
- Where
- South Korea
- Volunteers
- 100,000 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients.
- Trial name
- APP (NCT03982485)
- Testing
- Apatinib, Paclitaxel, Cisplatin
- Where
- China
- Volunteers
- 196 people
- Sponsor
- RenJi Hospital
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma
- Trial name
- NCT06042569
- Testing
- Cyclophosphamide, Docetaxel, Medical Chart Review
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- City of Hope Medical Center
Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.
- Conditions
- Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Circulating Tumor Cells
- Trial name
- TREAT-CTC (NCT01548677)
- Testing
- trastuzumab
- Where
- 80 sites in Belgium, France and 2 more
- Volunteers
- 1,317 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Breast
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2
- Trial name
- NCT06791161
- Testing
- Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNADalHR (NCT06970912)
- Testing
- Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy
- Where
- China
- Volunteers
- 393 people
- Sponsor
- Peking University People's Hospital
Breast Cancer
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative…
- Trial name
- NCT07492394
- Testing
- entinostat, Dalpiciclib, Letrozole
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Neoplasm Female
Evaluation of ATRA Activity in Combination With Anastrozole in Pre-operative Phase of Operable Early Breast Cancer
This is an Italian, single center, randomized, phase II study. ATRA (all-trans retinoic acid) and derivatives (retinoids) are promising anticancer agents and exert their anti-proliferative, differentiating and apoptotic effects…
- Trial name
- ATRA (NCT04113863)
- Testing
- all-trans retinoic acid, Anastrozole 1mg
- Where
- 2 sites in Italy
- Volunteers
- 76 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Breast Cancer, Hyperinsulinism
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.
- Conditions
- Breast Cancer, Hyperinsulinism, HER2-negative Breast Cancer
- Trial name
- NCT05989347
- Testing
- Dapagliflozin 10mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Yale 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.
Solid Tumor
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
This is an prospective, multicenter, single-arm clinical study.
- Trial name
- NCT05525767
- Testing
- Bevacizumab
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Hebei Medical University Fourth Hospital
Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells.
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT01754519
- Testing
- Therapeutic Conventional Surgery, Radiation Therapy, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Roswell Park Cancer Institute
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
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
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 Cancer Stage II
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage…
- Trial name
- ACNTBC (NCT05558722)
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Xijing Hospital