Clinical trials: Early-Stage Invasive Breast Carcinoma
HER2-negative Breast Cancer
Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling
This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who…
- Trial name
- FB-12 (NCT03412643)
- Testing
- Doxorubicin, Cyclophosphamide, Weekly Paclitaxel
- Where
- 43 sites in United States
- Volunteers
- 64 people
- Sponsor
- NSABP Foundation Inc
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Breast Cancer WEight Loss Study (BWEL Study)
This randomized phase III trial compares whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence).
- Conditions
- Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- Trial name
- NCT02750826
- Testing
- Health Education Program, Weight Loss Intervention
- Where
- 1,498 sites in United States, Canada and 2 more
- Volunteers
- 3,177 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Ann Arbor Stage I Lymphoma, Ann Arbor Stage II Lymphoma
- Trial name
- NCT05334069
- Testing
- Questionnaire Administration, Biospecimen Collection
- Where
- 747 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
- Trial name
- NRR (NCT00182728)
- Testing
- surgery, therapy, radiation therapy
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery
Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking.
- Trial name
- INSEMA (NCT02466737)
- Testing
- no axillary surgery versus SLNB, SLNB versus completion ALND
- Where
- 150 sites in Austria, Germany
- Volunteers
- 5,505 people
- Sponsor
- University of Rostock
Breast Cancer
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC).
- Trial name
- CALORIE (NCT03821454)
- Testing
- Capecitabine
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Zhejiang Cancer Hospital
Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer.
- Conditions
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v6, Stage IA Breast Cancer AJCC v7
- Trial name
- NCT01266642
- Testing
- External Beam Radiation Therapy, Hypofractionated Radiation Therapy, Laboratory Biomarker Analysis
- Where
- 7 sites in United States
- Volunteers
- 301 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Breast Cancer, Invasive Ductal
Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer.
- Conditions
- Breast Cancer, Breast Cancer, Invasive Ductal, Invasive Mammary Carcinoma, Breast Cancer Stage I
- Trial name
- NCT04088435
- Testing
- Intraoperative radiotherapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Louisville
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
Invasive Ductal Carcinoma, Ductal Carcinoma in Situ
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer.
- Trial name
- NCT01644669
- Testing
- Intra-operative Radiation Therapy - IORT
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Xoft, Inc.
Breast Cancer, Ductal Carcinoma in Situ
Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer
In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment.
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ, Invasive Breast Cancer
- Trial name
- NCT06677944
- Testing
- Preoperative PBI
- Where
- South Korea
- Volunteers
- 47 people
- Sponsor
- Yonsei University
Ductal Breast Cancer
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
- Trial name
- NCT00694577
- Testing
- Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions, Partial Breast Irradiation using 40 Gy /10 fractions
- Where
- 4 sites in United States
- Volunteers
- 324 people
- Sponsor
- Massachusetts General Hospital
Breast Cancer, Node-negative Breast Cancer
Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer
This is a multicenter, randomized, phase III non-inferiority trial in women aged 40 years or older with clinically node-negative (cN0), pathologically pT1 (≤2 cm), grade 1-2, lymphovascular invasion (LVI)-negative invasive breast…
- Conditions
- Breast Cancer, Node-negative Breast Cancer, Early-Stage Invasive Breast Carcinoma
- Trial name
- APROOB (NCT07757958)
- Testing
- Whole Breast Irradiation, Partial Breast Irradiation
- Where
- South Korea
- Volunteers
- 520 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Radiation Therapy in Treating Women With Early Stage Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
- Trial name
- NCT00909909
- Testing
- External beam boost, whole breast irradiation
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Rutgers, The State University of New Jersey
Breast Cancer
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
- Trial name
- NCT01463007
- Testing
- Accelerated partial breast irradiation, Extended Follow up
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Jaroslaw Hepel
HER2-normal
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
- Trial name
- NCT01328249
- Testing
- eribulin mesylate
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery
This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
- Trial name
- NCT05327608
- Testing
- Short-Term Fasting, Chemotherapy, Biospecimen Collection
- Where
- 5 sites in United States
- Volunteers
- 55 people
- Sponsor
- Thomas Jefferson University
Ductal Carcinoma In Situ, Invasive Breast Cancer
The Prone Breast Radiation Therapy Trial
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction…
- Trial name
- NCT01815476
- Testing
- Radiation Therapy Positioning Intervention
- Where
- 2 sites in Canada
- Volunteers
- 378 people
- Sponsor
- Toronto Sunnybrook Regional Cancer Centre
Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative)…
- Conditions
- Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer
- Trial name
- NCT06144944
- Testing
- Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel, Epirubicin or doxorubicin, cyclophosphamide, paclitaxel
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Prospective Validation of Ataraxis AI Test for Predicting Treatment Response in Neoadjuvant Breast Cancer
This study evaluates the real-world clinical workflow integration of a previously developed artificial intelligence (AI) prognostic test in breast cancer patients receiving neoadjuvant chemotherapy, and validates its accuracy in…
- Trial name
- ATARAXIS NEOP (NCT07327970)
- Testing
- multi-modal foundation AI test
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Young-Joon Kang