Clinical trials: Early Breast Cancer
Breast Cancer
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
The GATHER trial aim to evaluate the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy.
- Trial name
- GATHER (NCT07593976)
- Testing
- [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Centre Henri Becquerel
Breast Cancer, Triple Negative Breast Cancer
TNBC Gut Microbiota During Neoadjuvant Treatment
The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT06610097
- Testing
- Nutritional Counseling
- Where
- United States
- Sponsor
- Scripps Health
Early-stage Breast Cancer
Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)
REaCT ZOL will compare one 4 mg dose of Zoledronate vs. one 4 mg dose of Zoledronate given every 6 months for 3 years.
- Trial name
- REaCT-ZOL (NCT03664687)
- Testing
- Zoledronate
- Where
- 6 sites in Canada
- Volunteers
- 211 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer, Surgery
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain.
- Trial name
- PoLyDOL (NCT00304850)
- Testing
- polyamine-free diet
- Where
- 5 sites in France
- Volunteers
- 160 people
- Sponsor
- University Hospital, Bordeaux
Breast Cancer, Premenopausal Breast Cancer
Role of Individualized Intervention(s) in Hormone-Receptor Positive Early-stage Breast Cancer
Although combination endocrine therapy has been associated with significant reduction in risk of recurrence in younger women with hormone receptor positive breast cancer, it has been associated with more adverse effects and…
- Conditions
- Breast Cancer, Premenopausal Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- MyCHOICE (NCT03407768)
- Testing
- Individualized interventions
- Where
- 2 sites in Canada
- Volunteers
- 41 people
- Sponsor
- University of Saskatchewan
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
Invasive Breast Cancer
Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.
- Trial name
- NCT01916837
- Testing
- Sampling of tumor tissue, Sampling of tumor tissue after breast cancer surgery
- Where
- Belgium
- Volunteers
- 180 people
- Sponsor
- Jules Bordet Institute
Early Breast Cancer, Metastatic Breast Cancer
Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers
This trial is a translational, open-label, monocentric and prospective cohort study of participants with breast cancer aiming to create a combined ESPRESSO (= organelle properties) phenotype and spatial proteomics data collection…
- Trial name
- ESPRESSOBREAST (NCT07233928)
- Testing
- Tumor biopsy
- Where
- France
- Volunteers
- 1,050 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer
Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening. PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early…
- Trial name
- NCT00311636
- Testing
- cyclophosphamide, docetaxel, doxorubicin hydrochloride
- Where
- 18 sites in Italy
- Volunteers
- 280 people
- Sponsor
- Gruppo Italiano Mammella (GIM)
Low-Risk, Early Stage Breast Cancer
Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)
The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.
- Trial name
- NCT07629206
- Testing
- Cryoablation
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- IceCure Medical Ltd.
Breast Cancer
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy.
- Trial name
- NCT03761706
- Testing
- Engagement in Physical Activity, Questionnaires
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Early Breast Cancer, Metastatic Breast Cancer
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
- Conditions
- Early Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- RosHER (NCT05217381)
- Where
- 7 sites in Spain
- Volunteers
- 18,533 people
- Sponsor
- MedSIR
Early-Stage Breast Carcinoma
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer
Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear.
- Trial name
- NCT02481128
- Testing
- without preoperative access to lymphoscintigraphy findings
- Where
- 23 sites in Germany, Switzerland
- Volunteers
- 1,198 people
- Sponsor
- Kliniken Essen-Mitte
Breast Cancer, Chemotherapeutic Toxicity
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer subtype, i.e.
- Trial name
- NCT05302336
- Testing
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Where
- China
- Volunteers
- 402 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Acupuncture, Early-stage Breast Cancer
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling…
- Conditions
- Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I
- Trial name
- PACT (NCT05528263)
- Testing
- Acupuncture, Nature scenery with a relaxation exercise
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Dana-Farber Cancer Institute
Early Stage Breast Cancer
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer.
- Trial name
- REaCT-TC2 (NCT02816112)
- Testing
- Ciprofloxacin, Neupogen
- Where
- Canada
- Volunteers
- 458 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer, Triple-negative Breast Cancer
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes.
- Trial name
- ADAPT-TN-IV (NCT07178730)
- Testing
- Sacituzumab govitecan, Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA], SoC Chemotherapy
- Where
- 26 sites in Germany
- Volunteers
- 765 people
- Sponsor
- Women's Cancer Study Group GmbH
Cancer, Breast, Triple Negative Breast Cancer
VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis.
- Conditions
- Cancer, Breast, Triple Negative Breast Cancer, Early-stage Breast Cancer
- Trial name
- NCT06409221
- Testing
- Non-interventional study, Observational only
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Concr
Breast Cancer, Breast Cancer (Early Breast Cancer)
Luminal Breast Cancer Cryoablation
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
- Trial name
- LUBRECA (NCT07447414)
- Testing
- Cryoablation with liquid nitrogen (Prosense® system)
- Where
- Spain
- Volunteers
- 140 people
- Sponsor
- Lucía Graña López
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group