Clinical trials: HR+/HER2- Early Breast Cancer
HR+/HER2-breast Cancer
A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer
This is a randomized, controlled, open, phase III trial of adjuvant intensive therapy for early breast cancer with HR+/ HER2-SNF4 based on SNF molecular typing.
- Trial name
- NCT05889871
- Testing
- Standard endocrine therapy plus Apatinib
- Volunteers
- 916 people
- Sponsor
- Fudan University
Breast Cancer
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast…
- Trial name
- NCT05891093
- Testing
- Fluzoparib, Anastrozole, Letrozole
- Where
- 15 sites in China
- Volunteers
- 766 people
- Sponsor
- Fudan University
Breast Cancer
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells…
- Trial name
- NoLEEta (NCT07237256)
- Testing
- Chemotherapy followed by endocrine therapy and ribociclib treatment, De-escalation
- Where
- 138 sites in France, Germany and 3 more
- Volunteers
- 3,902 people
- Sponsor
- UNICANCER
HR+/HER2- Breast Cancer
Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens.
- Trial name
- NCT06860529
- Testing
- Serplulimab, Epirubicin, Albumin Paclitaxel
- Where
- China
- Volunteers
- 357 people
- Sponsor
- Henan Cancer Hospital
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
An Exploratory Study on Individualized Neoadjuvant Treatment Regimens for Early HR+/HER2+ Breast Cancer
HR+/HER2+ breast cancer belongs to a special type of tumor with dual-channel signal activation. However, in clinical treatment, the preferred approach is usually the inhibition of the HER2 signaling pathway.
- Trial name
- NCT07300215
- Testing
- individualized neoadjuvant treatment
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital of Bengbu Medical 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.
Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer
De-escalation in Axillary Surgery for Early-stage Breast Cancer
The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka).
- Trial name
- RIDES (NCT07098507)
- Testing
- sentinel lymph node biopsy, omission of sentinel lymph node biopsy
- Where
- Croatia
- Volunteers
- 620 people
- Sponsor
- Clinical Hospital Center Rijeka
Breast Neoplasms
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks…
- Trial name
- TP-II (NCT03272477)
- Testing
- Perjeta Injectable Product, Herceptin, Tamoxifen
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Palleos Healthcare GmbH
HR+/HER2+ Early Breast Cancer
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early…
- Trial name
- TAYLOR-003 (NCT07616427)
- Testing
- Fovinaciclib, Aromatase Inhibitors, Trastuzumab + Pertuzumab
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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.
HR+/HER2- Early Breast Cancer
A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide for HRD-positive, HR+/HER2- early breast cancer.
- Trial name
- NCT07162051
- Testing
- Fuzaparib, standard chemotherapy
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Xijing Hospital
Breast Cancer
Trastuzumab/Pertuzumab With Fulvestrant and Culmerciclib in HR+/HER2+ Early Breast Cancer
This phase II single-arm study is designed to evaluate the neoadjuvant efficacy of a chemotherapy-free regimen consisting of trastuzumab, pertuzumab, Culmerciclib, and fulvestrant in patients with treatment-naïve stage II-III…
- Trial name
- NCT07857226
- Testing
- Trastuzumab (or biosimilar), Pertuzumab, Culmerciclib
- Volunteers
- 31 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer, Early Stage
Ablation Compare With Surgery for Early Breast Cancer
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance.
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Trial name
- NCT07484087
- Testing
- breast conserving surgery, cryo-thermal ablation
- Where
- China
- Volunteers
- 264 people
- Sponsor
- Peking University People's Hospital
Metastatic Breast Cancer, Unresectable Breast Cancer
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with hormone receptor (HR)…
- Trial name
- NCT05977036
- Testing
- DiviTum® TKa assay
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree…
- Trial name
- GIM29-GIMOMIC (NCT06871501)
- Where
- 25 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Consorzio Oncotech
Breast Cancer
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
- Trial name
- NCT05263570
- Testing
- Standard Therapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shengjing Hospital
Breast Cancer, Early-stage Breast Cancer
Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer
This is a prospective, single-center, randomize-controlled study. The purpose of this study is to evaluate the efficacy of neoadjuvant CDK4/6 inhibitors in patients with high-risk EPclin multigene risk analysis and non-response…
- Trial name
- NeoMARS (NCT06650748)
- Testing
- Dalpiciclib, Letrozole
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking University